Ocular drug delivery device

• US 20070112318A1
• Filed: 08/25/2004
• Published: 05/17/2007
• Est. Priority Date: 08/26/2003
• Status: Active Grant

• Current Assignee: Amorphex Therapeutics Llc
• Original Assignee: Vista Scientific, LLC
• Inventors: Leahy, Charles, Labombard, Denis
• Granted Patent: US 8,167,855 B2
• Time in Patent Office: Days
• US Class Current: 604/294
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 27/06 Antiglaucoma agents or miotics

Abstract

An ocular device for insertion into an eye is provided and includes a body having an anterior surface and a posterior surface for placement on one of superior sclera and inferior sclera of the eye. The posterior surface is defined by a base curve that is substantially identical to a radius of curvature of the one of the superior sclera and inferior sclera of the eye. In one embodiment, the ocular device serves as an ocular drug delivery device and contains an active pharmaceutical agent, a lubricant, etc.

Claims

1. An ocular device for delivery of a therapeutic agent to an eye comprising:

a body having an anterior surface and a posterior surface for placement on one of a '"'"'superior sclera and inferior sclera of the eye, wherein the posterior surface is defined by a base curve and edge lift radii at peripheral edges thereof that are both complementary to and adapted to fit the sclera of the eye so as to permit the device to the held on the eye by fluid attraction and be retained on the eye without aid of an eyelid.

2. An ocular device for insertion into an eye comprising:

a body having an anterior surface and a posterior surface for placement on one of superior sclera and inferior sclera of the eye, the posterior surface being defined by a base curve and a peripheral curvature at edges of the body that is of a different radius of curvature than the base curve, wherein both the base curve and the peripheral curvature are substantially identical to a radius of curvature of the one of the superior sclera and inferior sclera of the eye.

3. The ocular device of claim 2, wherein the base curve of the posterior surface is spherical, aspherical or toric and is defined in relation to scleral anatomical geometry.

4. The ocular device of claim 2, wherein the body has a center section with a pair of lobes formed on each side thereof, each lobe having a horizontal width and height greater than a horizontal width and height, respectively, of the center section.

5. The ocular device of claim 4, wherein the body is symmetrical about a center axis extending across a width of the body.

6. The ocular device of claim 4, wherein each lobe has a greater mass and thickness than the center section.

7. The ocular device of claim 4, wherein the body has a volume of from about 70 μ

l to about 400 μ

l.

8. The ocular device of claim 4, wherein the body has at least one property selected from the group consisting of:

a horizontal width of from about 8 mm to about 35 mm, a height from about 1.0 mm to about 14 mm, and a thickness from about 0.10 mm to about 5.0 mm.

9. The ocular device of claim 2, wherein the body has front curves that are aspheric.

10. The ocular device of claim 2, wherein the body has front curves that are toric.

11. The ocular device of claim 2, wherein the perimeter edge is formed between the posterior surface and the anterior surface and has a geometry that promotes tear exchange underneath the body, stability of position of the device and comfort during wear.

12. The ocular device of claim 2, wherein the body is formed of a material that is free of erosion when placed in an eye environment.

13. The ocular device of claim 2, wherein the body is formed of a material that erodes when placed in an eye environment.

14. The ocular device of claim 2, wherein the body is formed of a combination of materials that are both erodable and free of erosion when placed in an eye environment.

15. The ocular device of claim 2, wherein the body has a posterior edge that is tapered away from the scleral surface with a degree of edge lift being defined by the radius and width of the peripheral curvature.

16. The ocular device of claim 2, wherein the body has a central vertical axis that extends across a width of the body and divides the body into two sections, the body having at least two areas of increased thickness that are orientated so as to be symmetrically disposed about the center axis and serve to maintain position and stability and minimize random movement of the device over the surface of the eye when the device is placed in the eye.

17. The ocular device of claim 4, wherein the center section is defined by a first perimeter edge, such edge being proximal to a cornea of the eye when the device is placed in the eye and having a shape corresponding approximately to a projection of a perimeter of the cornea, Such edge has an inwardly curved shape with a curvature such that if a corneal boundary, at the limbus of the eye, and a boundary of the device are projected into a corneal plane, the device has an approximately uniform clearance in relation to the corneal boundary when the device is placed on the superior or inferior sclera. The contour of this perimeter edge serves as a corneal relief curve.

18. The ocular device of claim 17, wherein a curvature of the corneal relief curve is a conic or spline projection of the curvature of a junction of the cornea and the sclera at the limbus.

19. The ocular device of claim 4, wherein the center section is defined by an edge that is distal to a cornea of the eye when the device is placed in the eye, the edge having an inwardly curved shape that is defined by a curvature that permits clearance of an insertion of a rectus muscle associated with the eye. The contour of this perimeter edge serves as a muscle relief curve.

20. The ocular device of claim 4, wherein the body has a center longitudinal (horizontal) axis that extends from one end to another end of the body and divides the body into two symmetric halves, wherein the center section has a mass that is greater on a side of the longitudinal axis that is distal to a cornea when the device is placed in the eye.

21. The ocular device of claim 2, wherein the posterior surface is defined by two edge lift radii in the form of two elliptical radii to permit the body to conform to a scleral surface which is slightly elliptical in shape.

22. The ocular device of claim 21, wherein a radius of curvature of the edge lift radii is from about 0.5 mm to about 5.0 mm flatter than a radius of curvature of the base curve.

23. The ocular device of claim 4, wherein a transition from each lobe to the center section is defined by transitional curves having a shape selected from the group consisting of:

linear, parabolic, elliptical and hyperbolic.

24. The ocular device of claim 2, wherein the base curve is defined between peripheral edges that have a different radius of curvature than the radius of curvature of the base curve so as to define an edge lift at the peripheral edge that promotes tear exchange and fluid attraction between the device and the eye resulting in retention of the device on the sclera underneath an eyelid.

25. The device of claim 4, wherein an apex of the center portion lies in a first plane and peripheral edges of the center portion lie in a second plane that is substantially parallel to the first plane, with a distance between the first plane and the second plane being between about 0.5 mm and about 5.0 mm.

26. The device of claim 4, wherein an anterior surface of the device is defined at least in part by a lenticular shape such that the lenticular radius of the anterior surface is at a minimum along a vertical meridian that extends through the central portion and divides the body into two halves.

27. The device of claim 2, wherein the anterior surface has a lenticular shape to enhance balance and minimize sensation of the device in interaction with a lid contact area.

29. A method of applying a pharmaceutical agent or lubricant to an eye comprising the steps of:

constructing an ocular device according to claim 2 and adding the pharmaceutical agent or lubricant to the device such that it is carried thereby; and

placing the ocular device on a superior sclera or inferior sclera of the eye.

30. The method of claim 29, wherein the step of placing the ocular device on the superior sclera or inferior sclera comprises the step of:

inserting the ocular device underneath the conjunctiva of the eye or Tenon'"'"'s capsule of the eye.

28. An article for wear on a superior sclera or inferior sclera of an eye comprising:

a body having an anterior surface and a posterior surface for placement on one of the superior sclera and inferior sclera of the eye, the posterior surface being defined by a system of complementary curves that includes a base curve and edge lift radii at peripheral edges thereof, the system of curves being adapted to fit the superior sclera and inferior sclera of the eye and configured to permit the body to be held on the eye by fluid attraction between the body and the eye.

31. An ocular drug delivery device for placement substantially on a sclera of an eye behind an eyelid comprising:

a preformed polymeric body having a posterior surface that is defined by a posterior radius of curvature that substantially conforms to a surface of the sclera on which the body is for placement, wherein the posterior radius of curvature is selected so that the body is retained on the sclera of the eye by fluid attraction therebetween, while permitting a degree of travel over the eye without interfering with a blinking motion of an eyelid of the eye underwhich the body is disposed.

32. The ocular drug delivery device of claim 31, wherein the posterior radius of curvature is spherical with a radius of from about 10 mm to about 16 mm.

33. An ocular drug delivery device comprising:

a body having an anterior surface and a posterior surface for placement on one of superior sclera and inferior sclera of the eye, the posterior surface being defined by a base curve and edge lift radii that are both substantially identical to a radius of curvature of the one of the superior sclera and inferior sclera of the eye; and

a sufficient amount of a pharmaceutically active agent or lubricant disposed within the body to treat a medical condition.