WO2026022370A1

WO2026022370A1 - Injector for intraocular drug delivery device

Info

Publication number: WO2026022370A1
Application number: PCT/EP2025/071513
Authority: WO
Inventors: Ruben DA SILVA FERNANDES; Mona COLLIENNE; Laetitia PAYEN
Original assignee: Eyed Pharma Sa
Current assignee: Eyed Pharma Sa
Priority date: 2024-07-26
Filing date: 2025-07-25
Publication date: 2026-01-29
Anticipated expiration: 2027-01-26

Abstract

The current invention relates to an injector for injecting an intraocular drug delivery device into an eye, said injector comprising an injector housing, a plunger longitudinally displaceable in the injector housing, and a cartridge connected to a distal end of the injector housing, said cartridge comprising: a chamber for at least temporarily storing said intraocular drug delivery device in a relaxed state, a cartridge funnel connected to a distal end of said chamber, and a cartridge tip connected to a distal end of said cartridge funnel, said cartridge tip having an inner width A and an inner height B, the ratio A/B being between 1.6 and 3.

Description

INJECTOR FOR INTRAOCULAR DRUG DELIVERY DEVICE

FIELD OF THE INVENTION

The present invention relates to an injector for injecting an intraocular drug delivery device into an eye. In a second aspect, the present invention also relates to a cartridge for storing an intraocular drug delivery device. In another aspect, the present invention also relates to a use for treating ocular diseases. In another aspect, the present invention also relates to a kit for injecting an intraocular drug delivery device into an eye.

BACKGROUND

The treatment of many diseases and disorders of the eye, especially in case of degenerative or persistent conditions, poses challenges of achieving and maintaining adequate therapeutic drug concentrations within the eye and its surrounding structures.

Implantable intraocular devices have the potential to avoid the shortcomings and complications that can arise from both systemic and local therapies (i.e. topical administration or intravitreal injections). These intraocular devices are often artificial lenses, so-called intra-ocular lenses (IOL'S). Many injector devices have been developed for the insertion of IOL's. Examples of such injector devices are known from EP3068341 and US2014303636. However, these injector devices are all only applicable for the insertion of specific lens bodies and may not be compatible with intra-ocular devices of different shapes, sizes, or rigidity. W02020261009 describes a plunger design with two flexible lateral compression arms. These arms help precompress the IOL as it is being pushed through the injector's nozzle. WO2016122805 describes a modular IOL.

In these devices the IOL's are folded, because they are designed to be foldable to fit through injector tips that pass through smaller incisions. Planar intraocular (drug delivery) devices, however, cannot be folded like non-planar intraocular devices such as IOL's. Planar intraocular devices may therefore not be used in injectors as described in the prior art because for example twisting, rotating or displacing during loading or injecting may occur and give rise to problems in the OR. The applicant notes that the above issues are especially problematic when the intraocular drug delivery device itself is thinner, and thus more fragile and prone to stress, such as planar and/or annular intraocular drug delivery devices. A thinner device is desirable, as it causes much less hinder for the patient (both in reduction of line of sight as well as in inconveniencing the eye) and can deliver the therapeutic agent more efficiently.

A further issue is that of linearization, i.e. allowing the device to be compressed correctly for placement in a compact (very narrow) configuration through a simple surgery without implementing extra stress in the intraocular drug delivery device, which is also addressed by the invention at hand.

In addition, during surgery, an ocular incision of typically 2 to 3 mm is made, by which the intraocular dug delivery device is inserted. However, it is not possible to inject an planar intraocular drug delivery device in the compressed state through an appropriate incision using the injectors that are currently described in the prior art. Known injector devices are therefore not suited for injecting planar intraocular drug delivery devices.

The aim of the invention is to provide an injector which eliminates those disadvantages.

SUMMARY OF THE INVENTION

The present invention and embodiments thereof serve to provide a solution to one or more of above-mentioned disadvantages. To this end, the present invention relates to an injector for injecting an intraocular drug delivery device into an eye according to claim 1. Preferred embodiments of the injector are shown in any of the claims 2 to 11.

In a second aspect, the present invention relates to a cartridge for receiving and at least temporarily storing an intraocular drug delivery device according to claim 12. More particular, the cartridge as described herein provides that an intraocular drug delivery device can be stored in a substantially stress-free orientation.

In a third aspect the present invention relates to a use for treating ocular diseases. In a fourth aspect, the invention relates to a kit for treating ocular diseases comprising an injector according to the first aspect and an intraocular drug delivery device. In a fifth aspect, the invention relates to a kit for receiving and storing an intraocular drug delivery device comprising a chamber according to the second aspect and an intraocular drug delivery device.

It is an object of the invention to provide an injector and cartridge for receiving, storing and injecting planar intraocular drug delivery devices, such as annular (ringshaped) intraocular drug delivery devices or intraocular drug delivery devices such as described in EP3566693.

In addition, an injector is to be provided which is optimized regarding the manipulation steps for preparing the intraocular drug delivery device and the injector. In particular, as few manipulation steps as possible should be necessary before delivery of the intraocular drug delivery device and the injector. This should reduce sources of error. This is especially true for planar intraocular drug delivery devices, which can be damaged by twisting and turning. Another object is to provide an injector which requires only small incisions in the eye in the application.

It is another object of the present invention to provide an alternative injector. In particular, it is an object to develop an injector that solves as many or all of the problems mentioned. In particular, an injector is to be developed which, taking into account the above-mentioned requirements, can be used with planar, such as annular, drug delivery devices or intraocular drug delivery devices comprising withdrawal assisting means.

It is an object of the invention to exclude faulty insertion of the intraocular drug delivery device.

DETAILED DESCRIPTION OF THE INVENTION

The present invention concerns an injector for injecting an intraocular drug delivery device into an eye.

Unless otherwise defined, all terms used in disclosing the invention, including technical and scientific terms, have the meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. By means of further guidance, term definitions are included to better appreciate the teaching of the present invention. As used herein, the following terms have the following meanings:

A "predetermined orientation" refers to an orientation of the intraocular drug delivery device which is necessary for injecting said intraocular drug delivery device in a correct position in the eye.

The terms "relaxed state", "relaxed planar state", "relaxed orientation", "uncompressed orientation", "resting state", and "uncompressed state" are synonyms and refer to a state or position wherein the intraocular drug delivery device is not manipulated by applied pressure or compression, and is therefore substantially planar or substantially flat, and stress-free.

The terms "injecting state", "stressed state", and "compressed state" are synonyms and refer to a state or position wherein the intraocular drug delivery device is manipulated by applied pressure or compression into a position ready for injection from the injector into the eye.

"A", "an", and "the" as used herein refers to both singular and plural referents unless the context clearly dictates otherwise. By way of example, "a compartment" refers to one or more than one compartment.

"About" as used herein referring to a measurable value such as a parameter, an amount, a temporal duration, and the like, is meant to encompass variations of +/- 20% or less, preferably +/-10% or less, more preferably +/-5% or less, even more preferably +/-1% or less, and still more preferably +/-0.1% or less of and from the specified value, in so far such variations are appropriate to perform in the disclosed invention. However, it is to be understood that the value to which the modifier "about" refers is itself also specifically disclosed.

"Comprise", "comprising", and "comprises" and "comprised of" as used herein are synonymous with "include", "including", "includes" or "contain", "containing", "contains" and are inclusive or open-ended terms that specifies the presence of what follows e.g., component and do not exclude or preclude the presence of additional, non-recited components, features, element, members, steps, known in the art or disclosed therein.

Furthermore, the terms first, second, third and the like in the description and in the claims, are used for distinguishing between similar elements and not necessarily for describing a sequential or chronological order, unless specified. It is to be understood that the terms so used are interchangeable under appropriate circumstances and that the embodiments of the invention described herein are capable of operation in other sequences than described or illustrated herein.

The recitation of numerical ranges by endpoints includes all numbers and fractions subsumed within that range, as well as the recited endpoints.

The expression "% by weight", "weight percent", "%wt" or "wt%", here and throughout the description unless otherwise defined, refers to the relative weight of the respective component based on the overall weight of the formulation.

Whereas the terms "one or more" or "at least one", such as one or more or at least one member(s) of a group of members, is clear per se, by means of further exemplification, the term encompasses inter alia a reference to any one of said members, or to any two or more of said members, such as, e.g., any >3, >4, >5, >6 or >7 etc. of said members, and up to all said members.

Unless otherwise defined, all terms used in disclosing the invention, including technical and scientific terms, have the meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. By means of further guidance, definitions for the terms used in the description are included to better appreciate the teaching of the present invention. The terms or definitions used herein are provided solely to aid in the understanding of the invention.

Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment but may. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner, as would be apparent to a person skilled in the art from this disclosure, in one or more embodiments. Furthermore, while some embodiments described herein include some, but not other features included in other embodiments, combinations of features of different embodiments are meant to be within the scope of the invention, and form different embodiments, as would be understood by those in the art. For example, in the following claims, any of the claimed embodiments can be used in any combination. In a first aspect, the invention provides an injector for injecting an intraocular drug delivery device into an eye, preferably into the sulcus of the eye.

In a particularly preferred embodiment, the intraocular drug delivery device is a intraocular drug delivery device for use in the treatment of glaucoma.

The injector of the invention comprises an injector housing, a plunger longitudinally displaceable in the injector housing, and a cartridge for receiving an intraocular drug delivery device. Preferably, the cartridge comprises a chamber, a cartridge funnel and a cartridge tip.

In a preferred embodiment of the invention, said chamber is suitable for at least temporarily storing said intraocular drug delivery device in a relaxed or uncompressed state. This is advantageous as the stress in the intraocular drug delivery device is reduced to a minimum.

In a particularly preferred embodiment, said injector comprises an injector housing, a plunger longitudinally displaceable in the injector housing, and a cartridge connected to a distal end of the injector housing, said cartridge comprising: a chamber for at least temporarily storing said intraocular drug delivery device in a relaxed state, a cartridge funnel connected to a distal end of said chamber, and a cartridge tip connected to a distal end of said cartridge funnel.

In a further preferred embodiment, said injector comprises an injector housing, a plunger longitudinally displaceable in the injector housing, and a cartridge connected to a distal end of the injector housing, said cartridge comprising: a chamber storing an annular intraocular drug delivery device in an uncompressed state, a cartridge funnel connected to a distal end of said chamber, and a cartridge tip connected to a distal end of said cartridge funnel.

In a further embodiment, said chamber, said cartridge funnel and said cartridge tip are fluidly connected. So, said cartridge funnel preferably being fluidly connected to a distal end of said chamber, and said cartridge tip preferably being fluidly connected to a distal end of said cartridge funnel. In a preferred embodiment of the invention, said chamber comprises positioning means. Preferably, the positioning means are for at least temporarily fixing said intraocular drug delivery device in a relaxed planar predetermined orientation. The positioning means are advantageous as on the one hand the stress in the intraocular drug delivery device will be reduced due to the lack of possible orientation change, and on the other hand, the intraocular drug delivery device can be fixed in a predetermined orientation necessary to enter the eye. "Temporarily fixing" refers in the current context to fixing (holding) an intraocular drug delivery device in a predetermined orientation up until the injector is used, thus up until the plunger is used to push the intraocular device out of the chamber.

In a particularly preferred embodiment of the invention, said chamber is suitable for at least temporarily storing said intraocular drug delivery device in a relaxed state, and said chamber comprises positioning means for at least temporarily fixing said intraocular drug delivery device in a relaxed planar predetermined orientation.

In a preferred embodiment of the invention, said positioning means are removable. This is advantageous as the positioning means can hold the intraocular drug delivery device in a predetermined orientation right up to the moment of compression and injection of the intraocular drug delivery device, wherein the positioning means can be removed prior to compression and injecting the intraocular drug delivery device into the eye.

By using said positioning means, faulty insertion of the intraocular drug delivery device can be excluded.

In a further preferred embodiment of the invention, said positioning means are removable from an exterior side of said chamber. This is advantageous because the positioning means can be removed without opening the chamber. Therefor the manipulation of the intraocular drug delivery device is minimized.

In an embodiment of the invention, said intraocular drug delivery device is a intraocular drug delivery device removable from the eye. For example, said intraocular drug delivery device can be injected into the eye and be removed after 1, 6, 12, 18, 24, 30 or 36 months in the eye.

In an embodiment of the invention, the intraocular drug delivery device comprises withdrawal assisting means, preferably fixedly attached to the intraocular drug delivery device. In a further and preferred embodiment, said withdrawal assisting means is adapted to assist the withdrawal of said intraocular drug delivery device. It is advantageous when using intraocular drug delivery devices comprising withdrawal assisting means that the withdrawal assisting means are located somewhere in the eye where it can easily be found by the surgeon. To that end it may be advantageous to insert the intraocular drug delivery device into a predetermined orientation into the eye. This is advantageous, so a surgeon can remove the intraocular drug delivery device, without burden, even after for example 1, 6, 12, 18, 24, 30 or 36 months in the eye.

Said positioning means are preferably positioned at a distal or proximal end of said chamber, more preferably at a distal end of said chamber. In a preferred embodiment of the invention, said positioning means are for at least temporarily fixing said withdrawal assisting means of said intraocular drug delivery device in a distal or proximal end of said chamber. The inventors have found that by fixing the withdrawal assisting means in the distal or proximal end of the chamber, the withdrawal assisting means will be positioned in the lower part of the sulcus of the eye, where it may keep its position due to gravity. This is an advantageous position for retrieval of the intraocular drug delivery device from the eye by the surgeon.

The predetermined orientation may also be advantageous in other situations wherein an intraocular drug delivery device has a certain shape or comprises certain features which require a predetermined orientation prior to injection into the eye. The reasons maybe of a mechanical or a medical kind.

In a preferred embodiment, said chamber comprises a internal lumen for receiving, and at least temporarily storing the intraocular drug delivery device. Said internal lumen allows the intraocular drug device at least temporarily to be stored in an uncompressed state.

In a preferred embodiment said chamber has a circular or regular convex polygonal shape, so it a planar intraocular drug delivery device may be stored in a relaxed state. Said polygonal shape, such as hexagonal, heptagonal, octagonal, nonagonal and decagonal, is preferably rounded. It is believed to be obvious that the internal lumen of said chamber has a corresponding shape.

In a further embodiment, said internal lumen has a radius R of between 4 and 8 mm, preferably of between 5 and 7 mm, more preferably between 5,5 and 6,5 mm. A "radius" as described herein needs to be interpreted as the circumradius in embodiments wherein the chamber has a regular convex polygon shape.

The chamber has a radius R and an inner height F. The height F is preferably between 0.1 and 3 mm, more preferably between 0.4 and 2 mm. The radius R is preferably 1 and 15 mm, preferably between 5 and 10 mm, more preferably between 5.5 and 7.5 mm. The ratio R/F is preferably between 2.5 and 25, more preferably between 3 and 15. The inventors found that this ratio will almost always prevent twisting of the implant.

In a preferred embodiment of the invention, said cartridge, preferably said chamber, comprises one or more openings, preferably one opening, through which a viscoelastic can be supplied to facilitate sliding of the intraocular drug delivery device during injection and to eliminate air present in the injector. Possible viscoelastics can be: Sodium Hyaluronate (Hyaluronic Acid); Chondroitin Sulfate; Methylcellulose; Hydroxypropyl Methylcellulose; Sodium Alginate; Polyacrylamide; Polyvinyl Alcohol; Hyaluronic Acid Derivatives; Sodium Chondroitin Sulfate-Hyaluronic Acid Mixture; Carboxymethylcellulose; Dextran; or combinations thereof.

The cartridge funnel has preferably the function of guiding the intraocular drug delivery device to a compressed state, which can subsequently fit through the cartridge tip. The plunger can push the uncompressed intraocular drug delivery device through the cartridge funnel, thereby compressing it to a compressed state. In a preferred embodiment of the invention, the distal end of the cartridge funnel has a similar, preferably essentially the same, height and width as the cartridge tip.

In a preferred embodiment, the plunger comprises at its distal end a cushion made of a deformable material, such as an elastomer. The elastomer can be a silicone elastomer, a polyurethane elastomer, natural rubber (latex), synthetic rubber (SBR, Nitrile, Neoprene) but preferably the cushion is made of a silicone elastomer. The inventors found that the silicone rubber has the ideal shore hardness and compression modulus for pushing the intraocular drug delivery device and deforming in the injector.

The cartridge funnel may be characterized by a funnel length D and a funnel angle E°. The combination of the funnel length (D) and funnel angle (E°) parameters are preferably so that the implant can fit in the cartridge funnel before entering the cartridge tip and such that the cushion fully encloses the cartridge funnel so that only the cartridge tip lumen is open.

The preferred funnel length D lies between 5 and 30 mm, more preferably between 10 and 25 mm, even more preferably between 15 and 25 mm. Because this funnel length will allow most ocular implants to fit.

The preferred funnel angle (E°) lies between 1° and 20°, more preferably between 5° and 15°, even more preferably between 5° and 10°. If the funnel angle is too low, it may not be possible to push the implant into the funnel due to the flexibility of the implant and the friction forces between the implant and the cartridge. If the funnel angle is too large then the cushion will undergo a lot of compression and this could result in buckling of the plunger or rupture of the cartridge.

The cartridge funnel preferably has at its proximal end a width of between 1 and 10 mm, more preferably between 3 and 8 mm, even more preferably between 5 and 6 mm.

A large funnel angle also reduces the pushability of the implant. Meaning that the implant will not be displaced as a whole but instead the most distal filament will be pushed towards the center of the implant and the injection of the implant will be unsuccessful. This happens when the frictional forces are higher than the flexibility of the implant filament in that defined configuration. Reducing the width will lead to a higher friction force but it will also significantly reduce the flexibility of the filament.

Said cartridge tip is suitable for insertion into the eye through an incision. In a further embodiment, said cartridge comprises a cartridge tip along the longitudinal axis for guiding the compressed intraocular drug delivery device into the eye through the incision. In a preferred embodiment of the invention, said cartridge tip is an oval cartridge tip. The inventors have unexpectedly found that an oval cartridge tip prevents the intraocular drug delivery device from twisting during injection, on the contrary to circular cartridge tips. An oval cartridge tip is characterized by an oval outer and inner circumference.

The expression "oval" refers to a two-dimensional geometric shape characterized by its curved outline. It encompasses a variety of shapes that share this basic characteristic, including those that closely resemble a true ellipse as well as shapes that exhibit some degree of asymmetry or distortion while still maintaining a general elongated elliptical form, and stadium-shapes.

In a preferred embodiment of the invention, said cartridge tip has an inner circumference and an outer circumference, and wherein the outer circumference at a distal end of the cartridge tip is at most 5.5 mm, preferably at most 5 mm. This allows a smaller incision size in the eye and prevents the intraocular drug delivery device from twisting during injection.

A cartridge tip according to an embodiment comprises an inner height B and an inner width A determining the inner circumference Cl. The inner width A is large enough to allow place for two times the diameter of the annular intraocular drug delivery device 2.

The ratio A/B is advantageously between 1.5 and 5, preferably between 1.6 and 5, more preferably between 1.6 and 4, more preferably between 1.6 and 3.5, more preferably between 1.6 and 3, even more preferably between 1.6 and 2.5. The inventors have found that between these ratios twisting of the intraocular drug delivery device during implantation is avoided. A ratio lower than A/B = 1.6 or higher than A/B = 4 would increase the risk of implant twisting. Further, the absolute values of A and B are advantageously minimized as these also determine the cartridge outer perimeter C2 which has a direct correlation with the corneal incision size.

In a preferred embodiment, said cartridge tip has an inner height B of at least 0.30 mm, preferably at least 0.50 mm, more preferably at least 0.55 mm, even more preferably at least 0.70 mm. A smaller inner height would lead to difficulties during injection molding in the manufacturing process. Furthermore, an inner height of at least 0.30 mm allows for compatibility with an intraocular drug delivery device with an outer diameter of 0.30 mm.

In another or a further preferred embodiment, said cartridge tip has an inner height B of at most 1 mm, preferably at most 0.95 mm, more preferably at most 0.90 mm, even more preferably at most 0.85 mm. The inventors have unexpectedly found that this inner height avoids twisting of the intraocular drug delivery device. A larger inner height will allow twisting of the intraocular drug delivery device during injection. In another or a further preferred embodiment, said cartridge tip has an inner height B of between 0.30 mm and 1 mm, preferably 0.50 and 0.95 mm, more preferably between 0.5 and 0.90 mm, even more preferably between 0.70 and 0.85 mm. The inventors have unexpectedly found that this inner height allows enough room for the passing of the compressed intraocular drug delivery device, without giving it room to twist during injection. This inner height allows smooth injection of the intraocular drug delivery device.

In a preferred embodiment, said cartridge tip has an inner width A of at least 0.70 mm, preferably at least 0.80 mm, more preferably at least 0.90 mm, even more preferably at least 1.0 mm, preferably at least 1.10 mm, even more preferably at least 1.20 mm, even more preferably at least 1.30 mm, still even more preferably at least 1.40 mm. A smaller inner width would lead to difficulties for guiding the compressed intraocular drug delivery device.

In another or a further preferred embodiment, said cartridge tip has an inner width A of at most 1.70 mm, preferably at most 1.60 mm, more preferably at most 1.50 mm. A maximum inner width is desirable to minimize the necessary incision size.

In another or a further preferred embodiment, said cartridge tip has an inner width A of between 1.0 mm and 1.70 mm, preferably 1.20 and 1.70 mm, more preferably between 1.40 and 1.50 mm. The inventors have unexpectedly found that this inner width allows enough room for the passing of the compressed intraocular drug delivery device, without giving it room to twist during injection. This inner width allows smooth injection of the intraocular drug delivery device through without increasing the necessary incision size.

In a particularly preferred embodiment, the injector comprises an injector housing, a plunger longitudinally displaceable in the injector housing, and a cartridge connected to a distal end of the injector housing, said cartridge comprising: a chamber for at least temporarily storing said intraocular drug delivery device (2) in a relaxed state, a cartridge funnel connected to a distal end of said chamber, and a cartridge tip connected to a distal end of said cartridge funnel, said cartridge tip having an inner width A and an inner height B, the ratio A/B being between 1.6 and 3, and preferably wherein the inner width A is at most 1.7 mm and the inner height B is at most 0.9 mm. The design of the cartridge tip is especially advantageous for delivering an intraocular drug delivery device into the sulcus of the eye. Placement in the sulcus of the eye positively affects the effectiveness of the intraocular drug delivery device in especially the use for treatment of glaucoma. Its specialized shape and structure are essential for navigating the confined space of the eye (sulcus), ensuring accurate placement of the intraocular drug delivery device while minimizing potential trauma to the sensitive ocular tissues. Moreover, this cartridge tip facilitates controlled deployment of the device, crucial for its effective functioning, and enhances patient comfort and safety by reducing the risk of post-operative complications. This design makes the injector an advantageous for successful application of intraocular drug delivery devices in ocular treatments, and specifically glaucoma.

Said intraocular drug delivery device is preferably an extruded intraocular drug delivery device. Alternatively, said intraocular drug delivery device is preferably a planar, and more preferably an annular (ring-shaped), intraocular drug delivery device. More preferably, said intraocular drug delivery device is an extruded and planar, preferably annular, intraocular drug delivery device. In some embodiments, the intraocular drug delivery device comprises withdrawal assisting means.

Said intraocular drug delivery device is preferably a sustained release intraocular drug delivery device configured for the sulcus of the eye, comprising:

(a) a polymeric matrix core into which at least one therapeutic agent is mixed, and;

(b) a polymeric coating completely surrounding said polymeric matrix material.

In a second aspect, the invention relates to a cartridge for receiving and/or storing an intraocular drug delivery device.

The cartridge according to the second aspect can be fixedly or removably connected to the injector housing of an injector. Advantageously, the cartridge according to the second aspect is designed as a cartridge for insertion into an injector housing of an injector, preferably an injector according to the first aspect. Alternatively, the chamber according to the second aspect may be an integrated part of an injector, preferably an injector according to the first aspect.

In a particularly preferred embodiment, said cartridge comprises: a chamber for at least temporarily storing said intraocular drug delivery device in a relaxed state, a cartridge funnel connected to a distal end of said chamber, and a cartridge tip connected to a distal end of said cartridge funnel.

The features and embodiments of the cartridge according to the second aspect correspond to the cartridge as described above.

In a preferred embodiment of the invention, said the chamber is sealed at the proximal end of the chamber with a removable seal. In another or a further preferred embodiment of the invention, said the cartridge tip is sealed at the proximal end of the chamber with a removable seal, such as a cap. In this embodiment the cartridge can be used for storage of the intraocular drug delivery device and opened prior to insertion into the injector.

Alternatively, when the cartridge is an integrated part of an injector, the chamber may comprise a lid for opening the chamber and loading it with an intraocular drug delivery device.

In a third aspect, the invention relates to a use of an injector according to the first aspect for treating ocular diseases, wherein said injector is for injecting an intraocular drug delivery device into an eye.

As used herein, the term "ocular disease" refers to any condition which affects or involves the eye or one of the parts or regions of the eye. Broadly speaking, the eye includes the eyeball and the tissues and fluids which constitute the eyeball, the periocular muscles (such as the oblique and rectus muscles) and the portion of the optic nerve which is within or adjacent to the eyeball.

An anterior ocular disease is any condition which affects or which involves an anterior (i.e. front of the eye) ocular region or site, such as a periocular muscle, an eye lid or an eye ball tissue or fluid which is located anterior to the posterior wall of the lens capsule or ciliary muscles. Thus, an anterior ocular disease primarily affects or involves the conjunctiva, the cornea, the anterior chamber, the iris, the lens or the lens capsule and blood vessels and nerve which vascularize or innervate an anterior ocular region or site. Examples of anterior ocular diseases which can be treated using the sustained release intraocular drug delivery device of the present application include astigmatism; blepharospasm; conjunctival diseases; conjunctivitis; corneal diseases; corneal ulcer; dry eye syndromes; eyelid diseases; lacrimal apparatus diseases; lacrimal duct obstruction; myopia; presbyopia; pupil disorders; refractive disorders and strabismus. Glaucoma and ocular hypertension may also be considered to be an anterior ocular disease because a clinical goal of glaucoma treatment can be to reduce ocular hypertension, caused by excess of aqueous fluid in the anterior chamber of the eye (i.e. reduce intraocular pressure).

A posterior ocular disease is any condition which primarily affects or involves a posterior ocular region or site such as choroid or sclera (in a position posterior to a plane through the posterior wall of the lens capsule), vitreous, vitreous chamber, retina, optic nerve (i.e. the optic disc), and blood vessels and nerves which vascularize or innervate a posterior ocular region or site. Examples of posterior ocular diseases which can be treated using the sustained release intraocular drug delivery device of the present application include acute macular neuroretinopathy; Behcet's disease; choroidal neovascularization; diabetic uveitis; histoplasmosis; infections, such as fungal or viral-caused infections; macular degeneration, such as acute macular degeneration, non-exudative age related macular degeneration and exudative age related macular degeneration; edema, such as macular edema, cystoid macular edema and diabetic macular edema; multifocal choroiditis; ocular trauma which affects a posterior ocular site or location; ocular tumors; retinal disorders, such as central retinal vein occlusion, diabetic retinopathy (including proliferative diabetic retinopathy), proliferative vitreoretinopathy (PVR), retinal arterial occlusive disease, retinal detachment, uveitic retinal disease; sympathetic opthalmia; Vogt Koyanagi-Harada (VKH) syndrome; uveal diffusion; a posterior ocular condition caused by or influenced by an ocular laser treatment; posterior ocular conditions caused by or influenced by a photodynamic therapy, photocoagulation, radiation retinopathy, epiretinal membrane disorders, branch retinal vein occlusion, anterior ischemic optic neuropathy, non-retinopathy diabetic retinal dysfunction, retinitis pigmentosa, and glaucoma. Glaucoma may be considered a posterior ocular condition because the therapeutic goal is to prevent the loss of or reduce the occurrence of loss of vision due to damage to or loss of retinal cells or optic nerve cells (i.e. neuroprotection).

As used herein, the terms "treat", "treating", or "treatment", refer to reduction, resolution or prevention of an ocular disease, ailment or condition, or to promote healing of injured or damaged ocular tissue. A treatment is usually effective to reduce at least one symptom of an ocular disease, ailment or condition. In a fourth aspect, the invention relates to a kit for treating ocular diseases comprising: an injector according to the first aspect, and an intraocular drug delivery device, wherein said intraocular drug delivery device is positioned in an uncompressed state in the chamber.

In a fifth aspect, the invention relates to a kit for receiving and storing an intraocular drug delivery device comprising: a cartridge according to the second aspect, and an intraocular drug delivery device, wherein said intraocular drug delivery device is positioned in an uncompressed state in the cartridge.

The invention is further described by the following non-limiting examples which further illustrate the invention, and are not intended to, nor should they be interpreted to, limit the scope of the invention.

EXAMPLES AND DESCRIPTION OF FIGURES

The following numbering refers to:

1 : Injector

2: Intraocular drug delivery device

3: Injector housing

4: Plunger

5: Longitudinal direction

6: Cartridge

7: Chamber

8: Cartridge funnel

9: Cartridge tip

10: Distal end

11: Handle

12: Cushion

13: Positioning means

14: Pins

15: Pin holes

16: Opening for a viscoelastic or lubricating fluid

17: Viscoelastic or lubricating fluid

With as a goal illustrating better the properties of the invention the following presents, as an example and limiting in no way other potential applications, a description of a number of preferred applications of the method for examining the state of the grout used in a mechanical connection based on the invention, wherein : FIG. 1-4 present an embodiment of an injector according to this disclosure loaded with an annular intraocular drug delivery device.

FIG. 5-8 present a working embodiment of an injector according to this disclosure during injection of the annular intraocular drug delivery device.

FIG. 9-10 present embodiments of the cartridge tip of an injector according to the current disclosure.

FIG. 11 presents a cartridge according to an embodiment of the present invention. FIG. 12-15 present a working embodiment of an injector according to this disclosure during injection of the annular intraocular drug delivery device without withdrawal assisting means.

Figures 1-4

Figures 1-4 present an injector 1 in a storage configuration. In this configuration the intraocular drug delivery device 2 is in a relaxed state. Figures 1 and 2 show a cross- sectional side-view of an injector loaded with an annular intraocular drug delivery device 2. Figures 3 and 4 show a cross-sectional top-view of an injector loaded with an annular intraocular drug delivery device 2.

An injector 1 for injecting an intraocular drug delivery device 2 into the eye comprises an injector housing 3, a plunger 4 longitudinally 5 displaceable in the injector housing 3, and a cartridge 6 comprising a chamber 7 for receiving a planar, preferably annular, intraocular drug delivery device 2. The cartridge 6 further comprises a cartridge funnel 8 and a cartridge tip 9 at a distal end 10 of the injector 1. The injector 1 in this embodiment also comprises a handle 11 for easy handling by a surgeon.

The plunger 4 is longitudinally displaceable in said injector housing 3, wherein the plunger 4 is to be guided in translation along the longitudinal axis 5 so as to move a distal end of the plunger 4 through the cartridge 6, thereby pushing the intraocular drug delivery device through the chamber 7, the cartridge funnel 8 and the cartridge tip 9 into the eye. The plunger 4 comprises at its distal end a cushion 12 made of a deformable material such as an elastomer. The elastomer can be a silicone elastomer, a polyurethane elastomer, natural rubber (latex), synthetic rubber (SBR, Nitrile, Neoprene) but preferably the cushion is made of a silicone elastomer. The inventors found that the silicone rubber has the ideal shore hardness and compression modulus for pushing the intraocular drug delivery device and deforming in the injector. The cushion 12 makes contact with the intraocular drug delivery device 2 when it is pushed through the cartridge 6.

The chamber 7 is suitable for at least temporarily storing said annular intraocular drug delivery device in a relaxed state. The chamber 7 comprises further positioning means 13. The positioning means 13 are for at least temporarily fixing said intraocular drug delivery device in a relaxed planar predetermined orientation.

The positioning means 13 are removable. This is advantageous as the positioning means can hold the intraocular drug delivery device 2 in a predetermined orientation right up to the moment of injection of the intraocular drug delivery device 2, wherein the positioning means 13 can be removed prior to pressing and injecting the intraocular drug delivery device 2 into the eye.

By using said positioning means 13, faulty insertion of the intraocular drug delivery device 2 can be excluded.

In this embodiment, said positioning means 13 are removable from an exterior side of said cartridge 6. This is advantageous because the positioning means 13 can be removed without opening the cartridge 6. Therefor the manipulation of the intraocular drug delivery device 2 is minimized.

In a preferred embodiment, the positioning means 13 comprises a number of pins 14 for inserting through pin holes 15 in the cartridge 6. The number of pins 14 and the pin holes 15 are the same in number and corresponding in shape so a malefemale connection is created when the positioning means 13 are provided on the cartridge 6.

The cartridge 6 comprises pin holes 15 for receiving the positioning means 13. In this embodiment a positioning means 13 with three pins 14 is provided in three corresponding pin holes 15 in the cartridge.

The cartridge 6 further comprises one or more openings 16, through which a viscoelastic or lubricating fluid 17 can be supplied to facilitate sliding of the intraocular drug delivery device 2 during injection.

To increase visibility the positioning means 13 are not shown on figures 3 and 4. The cartridge 6 and the injector housing 3 can be manufactured as a whole component or as separate components. In the latter embodiment, the cartridge 6 is insertable into the distal end of the injector housing 3 as to form an injector 1. The connection between the injector housing 3 and the cartridge 6 can be made similar to other IOD injectors.

The plunger 4 is mounted in a starting position in the injector housing 3, preferably locked so that it is not in the way when inserting the cartridge 6 in the case where the cartridge 6 and the injector housing 3 are two separate components.

In one aspect, the invention provides a preloaded injector 1 for injecting an intraocular drug delivery device 2 into an eye. The term "preloaded" as used herein means that the injector 1 is packaged together with an intraocular device 2 wherein the intraocular device 2 is held by a cartridge 6 in a storage position on the injector. In an alternate preferred embodiment of the invention, the injector 1 is "semipreloaded" meaning that the intraocular drug delivery device 2 and cartridge 6 are packaged together but not yet coupled to the injector 1. In this alternate embodiment, the doctor or nurse attaches the cartridge 6 and intraocular drug delivery device 2 to the injector housing 3 at the time of surgery.

Figures 5-8

Figure 5 shows that before the intraocular drug delivery device 2 is pushed though the narrowest section of the cartridge 6, the cushion 12 will be fully enclosed by the lumen of the cartridge 6 to exert a forward pressure on the viscoelastic 17 and intraocular drug delivery device 2. Note that at this stage the pin holes 14 are also proximal to the location of the cushion 12. Otherwise, the pressure would escape through these holes 15 (pressure release) resulting in the implant not having the support of the forward pressure on the viscoelastic. Up until this stage the cushion was only pushing on the implant and the viscoelastic 17 was able to escape from the sides.

Figure 6 shows the deformation of the cushion in the narrowest tunnel of the cartridge 6, the cartridge tip 9.

Figures 7 and 8 show the position of the plunger 4 and cushion 17 once the whole intraocular drug delivery device 2 has been injected.

Figures 9-10 A cartridge tip 9 according to an embodiment comprises an inner height B and an inner width A determining the inner circumference Cl. The inner width A is large enough to allow place for two times the diameter of the annular intraocular drug delivery device 2.

The ratio A/B is advantageously between 1.6 and 3. The inventors have found that between these ratios twisting of the intraocular drug delivery device during implantation is avoided. A ratio lower than A/B = 1.6 or higher than A/B = 3 would increase the risk of implant twisting. Further, the absolute values of A and B are advantageously minimized as these determine the cartridge outer perimeter C2 which has a direct correlation with the corneal incision size.

Figure 9 show a cartridge tip 8 with a cross-section composed of two half circles and straight middle segment (stadium-shaped). This cross-section can also be an ellipse to further minimize the perimeter and reduce the incision size, as presented in figure 10. For example, an ellipse with the same inner height (for example, 0.8 mm) and width (for example, 1.5 mm) as presented will lead to an outer perimeter of 4.71 mm which is a reduction of 4.7% with respect to the first design (4.9 mm).

Prior art injectors have circular insertion tips. The change in dimension and shape to an oval or ellipse channel as shown in figure 9 and 10 prevents twisting of the annular intraocular drug delivery device 2.

Figure 11

Figure 11 shows a cartridge 6, with a funnel length D and a funnel angel E°. The combination of the funnel length D and funnel angle E° parameters are preferably such that the implant can fit in the funnel before entering the narrowest tunnel of the cartridge and the cushion fully encloses the cartridge so that only the tip lumen is open.

The cartridge tip 9 has a length G of between 5 and 7 mm, preferably between 5.5 and 6.5 mm.

The chamber 7 has a radius R and an inner height F. The height F is preferably between 0.1 and 3 mm, more preferably between 0.4 and 2 mm. The radius R is preferably 1 and 15 mm, preferably between 5 and 10 mm, more preferably between 5.5 and 7.5 mm. The ratio R/F is preferably between 2.5 and 25, more preferably between 3 and 15. The inventor found that this ratio will almost always prevent twisting of the implant.

The present invention is in no way limited to the embodiments described in the examples and/or shown in the figures. On the contrary, methods according to the present invention may be realized in many different ways without departing from the scope of the invention.

Figures 12-15

Figures 12-15 are analogous to the figures 4-7, with the difference that the annular drug delivery device does not comprise withdrawal assisting means. As a result thereof the cartridge does not comprise positioning means or pin holes.

Example 1 and comparative example 2

Tests on an animal model were carried out to verify the occurrence of implant twisting. During testing with an animal model an injector according to the current invention was compared with other IOL injectors on the market which are known for being compatible with a 2.2-2.4 mm incision size. The following injectors were tested with an annular intraocular drug delivery device on explanted New Zealand rabbit eyes: • an injector according to the invention having an inner width A of 0.8 mm and an inner height B of 1.5 mm the ratio A/B being 1.875 (example 1);

• an injector designed for IOL'S as known in the prior art with a circular cross-section, thus a ratio A/B being 1 (comparative example 2);

• an injector designed for IOL's with an inner width A of 2,03 mm and an inner height B of 1,73 mm, the ratio A/B being roughly 1.3 (comparative example 3);

• an injector according to the invention having an inner width A of 0.5 mm and an inner height B of 1.5 mm the ratio A/B being 3 (example 4);

The occurrence of implant twisting during simulated injection was observed in comparative examples 2 and 3. This phenomenon is undesirable, as it may complicate positioning of the implant and increase the risk of intraoperative difficulties. By contrast, no implant twisting was observed during simulated injection in example 1 and 4. Notably, implant twisting also occurred in comparative example 3, despite its oval cross-section. This suggests that not all non-circular injector geometries are suitable for use with annular intraocular devices. No implant twisting was observed with the injector of example 1 and 4. The inventors found that a cross- sectional ratio A/B within the range of 1.6 to 3 is particularly effective in minimizing the risk of twisting during injection.

Claims

1. An injector (1) suitable for injecting an annular intraocular drug delivery device (2) into an eye, said injector (1) comprising an injector housing (3), a plunger (4) longitudinally displaceable in the injector housing (3), and a cartridge (6) connected to a distal end of the injector housing (3), said cartridge (6) comprising: a chamber (7) for at least temporarily storing said intraocular drug delivery device (2) in an uncompressed state, a cartridge funnel (8) connected to a distal end of said chamber (7), and a cartridge tip (9) connected to a distal end of said cartridge funnel (8), said cartridge tip having an inner width A and an inner height B, the ratio A/B being between 1.6 and 3, wherein the inner width A is at most 1.7 mm and the inner height B is at most 0.9 mm.

2. Injector (1) according to claim 1, said cartridge funnel (8) having a funnel angle E° of between 5° and 10°, and said cartridge funnel (8) having a funnel length D of between 10 and 25 mm.

3. Injector (1) according to any of the previous claims, said chamber (7) having a radius R and an inner height F, the ratio R/F being between 2.5 and 25.

4. Injector (1) according to any of the preceding claims, said cartridge tip (9) being an oval cartridge tip (9).

5. Injector (1) according to any of the preceding claims, said intraocular drug delivery device (2) being an annular intraocular drug delivery device (2).

6. Injector (1) according to any of the previous claims, said chamber (7) comprising positioning means (13) for at least temporarily fixing said intraocular drug delivery device (2) in an uncompressed state.

7. Injector (1) according to claim 6, said positioning (13) means being positioned at a distal end or a proximal end of said chamber (7).

8. Injector (1) according to claim 6 or 7, said positioning means (13) being removable from an exterior side of said chamber (7).

9. Injector (1) according to any of the preceding claims, said cartridge tip having an inner circumference and an outer circumference, said outer circumference being at most 5 mm.

10. Injector (1) according to one of the preceding claims, said cartridge tip having an inner height of between 0.5 and 0.9 mm.

11. A cartridge (6) suitable for receiving an annular intraocular drug delivery device (2), said cartridge comprising: a chamber (7) for at least temporarily storing said intraocular drug delivery device (2) in an uncompressed state, a cartridge funnel (8) connected to a distal end of said chamber (7), and a cartridge tip (9) connected to a distal end of said cartridge funnel (8), said cartridge tip having an inner width A and an inner height B, the ratio A/B being between 1.6 and 3, wherein the inner width A is at most 1.7 mm and the inner height B is at most 0.9 mm.

12. Use of an injector (1) according to claim 1-10 for treating ocular diseases, wherein said injector (1) is for injecting an intraocular drug delivery device (2) into an eye.

13. Kit for treating ocular diseases comprising: an injector (1) according to any of the claims 1-10, and an intraocular drug delivery device (2), wherein said intraocular drug delivery device (2) is positioned in an uncompressed state in the chamber (7).

14. Kit for storing an intraocular drug delivery device comprising: a cartridge (6) according to claim 11, and an intraocular drug delivery device (2), wherein said intraocular drug delivery device (2) is positioned in an uncompressed state in the chamber (7).

15. Injector (1) according to claim 13 or 14, said intraocular drug delivery (2) comprising withdrawal assisting means.

16. Injector (1) according to claim 15, the chamber (7) comprising positioning means (13), wherein said positioning means (13) are suitable for fixing said withdrawal assisting means in a distal or a proximal end of said chamber (7).