Device and Method for the Delivery of Drugs for the Treatment of Posterior Segment Disease

• US 20080318843A1
• Filed: 09/02/2008
• Published: 12/25/2008
• Est. Priority Date: 04/09/2003
• Status: Active Grant

• Current Assignee: Direct Contact, LLC
• Original Assignee: Direct Contact, LLC
• Inventors: Schultz, Clyde L., Schentag, Jerome J.
• Granted Patent: US 9,216,106 B2
• Time in Patent Office: Days
• US Class Current: 514/9
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61K 38/13 Cyclosporins
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61P 27/02 Ophthalmic agents

Abstract

Hydrogel lenses are infused with a drug for the treatment of posterior segment disease. The lenses are placed in contact with the subject'"'"'s cornea. Drugs can be passively released from the hydrogel and can migrate around the globe of the eye to the posterior segment.

Claims

1. A method of delivering a drug or drug precursor to the posterior segment of the eye for the treatment of posterior segment disease, the method comprising:

contacting a polymeric hydrogel with the cornea of a subject in need of treatment or prevention of posterior segment disease, the polymeric hydrogel including the drug or drug precursor at a first concentration; and

passively transferring the drug or drug precursor around the globe of the eye to the posterior segment.

2. The method of claim 1 wherein the drug or drug precursor is transferred to the posterior segment via the eye circulatory system, the eye musculature or the eye nerve system.

3. The method of claim 1 wherein a concentration of the drug or drug precursor in the subject does not exceed 1% of the first concentration.

4. The method of claim 1 wherein the hydrogel is continuously contacted with the cornea for a period of greater than 5 minutes.

5. The method of claim 1 wherein the hydrogel is continuously contacted with the cornea for a period of greater than 3 hours.

6. The method of claim 1 wherein the hydrogel is continuously contacted with the cornea for a period of greater than 24 hours.

7. The method of claim 1 wherein the hydrogel is continuously contacted with the cornea for a period of greater than one week.

8. The method of claim 1 wherein a drug precursor is delivered.

9. The method of claim 1 wherein a drug is delivered.

10. The method of claim 1 wherein the drug or drug precursor comprises an angiogenesis inhibitor or an angiogenesis inhibitor precursor.

11. The method of claim 1 wherein the drug or drug precursor is selected from the group consisting of beclomethasone, prednisolone, prednisone, fluticasone, budesonide, betamethasone dipropionate, amelometasone, mometasone, ciclesonide, triamcinolone acetonide, fludrocorisone and flumethasone.

12. The method of claim 1 wherein the drug or drug precursor is metabolized at the posterior segment.

13. The method of claim 1 wherein the drug or drug precursor comprises an anti-inflammatory compound or growth factor.

14. The method of claim 1 wherein the drug or drug precursor comprises at least one of cyclosporin, sirolimus, rapamycin, and a cyclophilin A, B, or D inhibitor.

15. The method of claim 1 wherein the drug or drug precursor comprises a short acting corticosteroid.

16. The method of claim 1 wherein the drug or drug precursor comprises a fat soluble vitamin.

17. The method of claim 15 wherein the drug or drug precursor comprises vitamin A and/or vitamin E.

18. The method of claim 1 wherein the drug or drug precursor comprises a steroid selected from the group consisting of estrogens, androgens, progestagens, glucocorticoids, mineralocorticoids, phytosterols and ergosterols.

19. The method of claim 1 wherein the drug or drug precursor comprises a steroid selected from the group consisting of squalene, lanosterol, cholesterol, pregnenolone, 17-hydrosypregnenolone, DHEA, androstenedione and androstanediol.

20. The method of claim 1 wherein the drug or drug precursor comprises a compound selected from the group consisting of prednisone, prednisolone, methylprednisolone, betamethasone, dexamethasone, triamcinolone, hydrocortisone, aldosterone, squalene, lanosterol, cholesterol, pregnenolone, 17-hydroxypregnenolone, DHEA, androstenedione, androstanediol, estradiol, estriol, estrone, testosterone, dihydrotestosterone, androsterone, progesterone, 17-hydroxyprogesterone, progestins, cortisol, prednisone, stigmasterol, brassicasterol, ergosterol, ergocalciferol and derivatives thereof.

21. The method of claim 1 wherein the posterior segment disease is at least one of retinal detachment (wound), diabetic retinopathy, macular degeneration, age-related macular degeneration, proliferative vitreoretinopathy, endophthalmitis, retinopathy of prematurity, posterior or anterior segment trauma (wound), intraocular lens-related posterior segment complications, retinal vascular diseases, macular edema, intraocular tumors, hereditary retinal degenerations, AlDS-related retinitis and posterior segment uveitis.

22. The method of claim 1 wherein the systemic blood concentration of the drug or drug precursor in the subject does not exceed 1% of the peak drug or drug precursor concentration in the hydrogel.

23. The method of claim 1 wherein the drug or drug precursor comprises zinc-monocysteine.

24. The method of claim 1 wherein the concentration of the drug or drug precursor in the vitreous humor of the eye being treated is less than the concentration of the drug or drug precursor in the posterior segment at the time of peak concentration in the posterior segment.

25. The method of claim 1 further comprising limiting the transfer of the drug into the vitreous to a first concentration that is below a second concentration that results in increased intraocular pressure in a majority of subjects.

30. The polymeric hydrogel of claim 24 wherein the hydrogel is infused with the drug at a concentration sufficient to provide efficacious levels in the posterior segment of both the drug and at least one drug metabolite.

26. A polymeric hydrogel comprising a drug for the treatment of a posterior segment disease, wherein said drug is capable of being passively released from the polymeric hydrogel in a therapeutically effective amount while the hydrogel is positioned on the eye to ameliorate and/or stabilize said posterior segment disease wherein the drug is selected from the group consisting of beclomethasone, prednisolone, prednisone, fluticasone, budesonide, betamethasone dipropionate, amelometasone, mometasone, ciclesonide, triamcinolone acetonide, fludrocorisone, flumethasone and derivatives thereof.

27. A polymeric hydrogel comprising a drug for the treatment of a posterior segment disease, wherein said drug is capable of being passively released from the polymeric hydrogel while positioned on the eye in a therapeutically effective amount to ameliorate and/or stabilize said posterior segment disease wherein the drug comprises a steroid selected from the group consisting of estrogens, androgens, progestagens, glucocorticoids, mineralocorticoids, phytosterols, ergosterols and derivatives thereof.

28. A polymeric hydrogel comprising a drug for the treatment of a posterior segment disease, wherein said drug is capable of being passively released from the polymeric hydrogel while positioned on the eye in a therapeutically effective amount to ameliorate and/or stabilize said posterior segment disease wherein the drug comprises an anti-inflammatory compound.

29. A polymeric hydrogel comprising a drug for the treatment of a posterior segment disease, wherein said drug is capable of being passively released from the polymeric hydrogel while positioned on the eye in a therapeutically effective amount to ameliorate and/or stabilize said posterior segment disease wherein the drug comprises a compound selected from the group consisting of cyclosporin, sirolimus, rapamycin, cyclophilin A, B, or D inhibitors and derivatives thereof.