CA2384255A1 - Ophthalmic drug delivery device - Google Patents

Ophthalmic drug delivery device Download PDF

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Publication number
CA2384255A1
CA2384255A1 CA002384255A CA2384255A CA2384255A1 CA 2384255 A1 CA2384255 A1 CA 2384255A1 CA 002384255 A CA002384255 A CA 002384255A CA 2384255 A CA2384255 A CA 2384255A CA 2384255 A1 CA2384255 A1 CA 2384255A1
Authority
CA
Canada
Prior art keywords
drug delivery
delivery device
active agent
pharmaceutically active
human eye
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002384255A
Other languages
French (fr)
Other versions
CA2384255C (en
Inventor
Yoseph Yaacobi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Alcon Inc
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2384255A1 publication Critical patent/CA2384255A1/en
Application granted granted Critical
Publication of CA2384255C publication Critical patent/CA2384255C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • A61K9/0051—Ocular inserts, ocular implants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
    • A61F9/0017—Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A61F2009/00885—Methods or devices for eye surgery using laser for treating a particular disease
    • A61F2009/00891—Glaucoma
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/00781—Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment

Abstract

The present invention is directed to a drug delivery device for a human eye.
The human eye has a sclera, an inferior oblique muscle, and a macula. The device of the present invention includes a pharmaceutically active agent, and a geometry that facilitates the implantation of the device on an outer surface of the sclera, beneath the inferior oblique muscle, and with the pharma-ceutically active agent disposed above the macula. Methods of delivery a pharmaceutically active agent to the posterior segment of the human eye are also disclosed.

Claims (35)

1. A drug delivery device for a human eye, said eye having a sclera, an inferior oblique muscle, and a macula, said device comprising:
a pharmaceutically active agent; and a geometry that facilitates an implantation of said device on an outer surface of said sclera, beneath said inferior oblique muscle, and with said pharmaceutically active agent disposed above said macula.
2. The drug delivery device of claim 1 wherein said geometry is a generally F-shaped geometry.
3. The drug delivery device of claim 1 wherein said geometry is a generally C-shaped geometry.
4. The drug delivery device of claim 1 wherein said geometry is a generally L-shaped geometry.
5. The drug delivery device of claim 1 further comprising:
a body having a scleral surface for placement proximate said outer surface of said sclera and a well having an opening to said scleral surface; and an inner core disposed in said well comprising said pharmaceutically active agent.
6. The drug delivery device of claim 5 wherein said body comprises a biocompatible, non-bioerodable material.
7. The drug delivery device of claim 5 wherein said body comprises a polymeric composition.
8. The drug delivery device of claim 7 wherein said polymeric composition comprises one or more polymers selected from the group consisting of silicone, polyvinyl alcohol, ethylene vinyl acetate, polylactic acid, nylon, polypropylene, polycarbonate, cellulose, cellulose acetate, polyglycolic acid, polylactic glycolic acid, cellulose esters, polyethersulfone, and acrylics.
9. The drug delivery device of claim 8 wherein said polymeric composition comprises silicone.
10. The drug delivery device of claim 5 wherein said body is impermeable to said pharmaceutically active agent.
11. The drug delivery device of claim 5 wherein said inner core is a tablet.
12. The drug delivery device of claim 5 wherein said inner core comprises a semi-solid form, and said pharmaceutically active agent is disposed within said semi-solid form.
13. The drug delivery device of claim 5 wherein said human eye comprises a Tenon's capsule, and said body comprises an orbital surface having a radius of curvature that facilitates said implantation of said device below said Tenon's capsule.
14. The drug delivery device of claim 1 wherein said scleral surface has a radius of curvature substantially equal to the radius of curvature of said human eye.
15. The drug delivery device of claim 1 wherein said pharmaceutically active agent is nepafenac.
16. The drug delivery device of claim 1 wherein said pharmaceutically active agent comprises a compound selected from the group consisting of 4,9(11)-Pregnadien-17.alpha.,21-diol-3.20-dione and 4,9(11)-Pregnadien-17.alpha.,21-diol-3,20-dione-21-acetate.
17. The drug delivery device of claim 1 wherein said pharmaceutically active agent comprises eliprodil.
18. The drug delivery device of claim 5 further comprising a retaining member extending from said body proximate said opening.
19. The drug delivery device of claim 5 wherein said body comprises a notch for facilitating an accommodation of said inferior oblique muscle during said implantation of said device.
20. The drug delivery device of claim 19 wherein said notch comprises a ramp.
21. A method of delivering a pharmaceutically active agent to a human eye, said human eye having a sclera, an inferior oblique muscle, and a macula, comprising the steps of:
providing a drug delivery device comprising a pharmaceutically active agent;
and disposing said device on an outer surface of said sclera, beneath said inferior oblique muscle, and with said pharmaceutically active agent disposed above said macula.
22. The method of claim 21 wherein said disposing step comprises disposing said device beneath a Tenon's capsule of said human eye.
23. The method of claim 21 wherein said drug delivery device further comprises:
a body having a scleral surface for placement proximate said outer surface of said sclera and a well having an opening to said scleral surface; and an inner core disposed in said well comprising said pharmaceutically active agent.
24. The method of claim 23 wherein said body comprises a biocompatible, non-bioerodable material.
25. The method of claim 23 wherein said inner core is a tablet.
26. The method of claim 23 wherein said inner core comprises a semi-solid form, and said pharmaceutically active agent is disposed within said semi-solid form.
27. The method of claim 23 wherein said body is impermeable to said pharmaceutically active agent.
28. The method of claim 23 wherein said scleral surface has a radius of curvature substantially equal to the radius of curvature of said human eye.
29. The method of claim 21 wherein said pharmaceutically active agent comprises a compound selected from the group consisting of 4,9(11)-Pregnadien-17.alpha.,21-diol-3,20-dione and 4,9(11)-Pregnadien-17.alpha.,21-diol-3,20-dione-21-acetate.
30. The method of claim 21 wherein said pharmaceutically active agent comprises eliprodil.
31. The method of claim 23 wherein said body comprises a notch, and wherein said disposing step comprises disposing a scleral side of said inferior oblique muscle in said notch.
32. The method of claim 21 wherein said device has a generally F-shaped geometry.
33. The method of claim 21 wherein said device has a generally C-shaped geometry.
34. The method of claim 21 wherein said device has a generally L-shaped geometry.
35. The method of claim 21 wherein said pharmaceutically active agent is nepafenac.
CA2384255A 1999-10-21 2000-10-12 Ophthalmic drug delivery device Expired - Fee Related CA2384255C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US16067399P 1999-10-21 1999-10-21
US60/160,673 1999-10-21
US09/664,790 US6416777B1 (en) 1999-10-21 2000-09-19 Ophthalmic drug delivery device
US09/664,790 2000-09-19
PCT/US2000/028187 WO2001028474A1 (en) 1999-10-21 2000-10-12 Ophthalmic drug delivery device

Publications (2)

Publication Number Publication Date
CA2384255A1 true CA2384255A1 (en) 2001-04-26
CA2384255C CA2384255C (en) 2010-01-26

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA2384255A Expired - Fee Related CA2384255C (en) 1999-10-21 2000-10-12 Ophthalmic drug delivery device

Country Status (19)

Country Link
US (4) US6416777B1 (en)
EP (1) EP1221919B1 (en)
JP (1) JP4685311B2 (en)
KR (1) KR100752821B1 (en)
CN (1) CN100341470C (en)
AR (2) AR026183A1 (en)
AT (1) ATE289500T1 (en)
AU (2) AU764226B2 (en)
BR (1) BR0014928B1 (en)
CA (1) CA2384255C (en)
DE (1) DE60018298T2 (en)
DK (1) DK1221919T3 (en)
ES (1) ES2237463T3 (en)
HK (1) HK1048428B (en)
PL (1) PL196539B1 (en)
PT (1) PT1221919E (en)
TR (1) TR200201046T2 (en)
TW (1) TW539560B (en)
WO (1) WO2001028474A1 (en)

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