Claims for Patent: 8,808,225

Summary for Patent: 8,808,225

Title:	Methods and devices for drug delivery to ocular tissue using microneedle
Abstract:	Methods and devices are provided for targeted administration of a drug to a patient\'s eye. In one embodiment, the method includes inserting a hollow microneedle into the sclera of the eye at an insertion site and infusing a fluid drug formulation through the inserted microneedle and into the suprachoroidal space of the eye, wherein the infused fluid drug formulation flows within the suprachoroidal space away from the insertion site during the infusion. The fluid drug formulation may flow circumferentially toward the retinochoroidal tissue, macula, and optic nerve in the posterior segment of the eye.
Inventor(s):	Prausnitz; Mark R. (Atlanta, GA), Edelhauser; Henry F. (Atlanta, GA), Patel; Samirkumar Rajnikant (Atlanta, GA)
Assignee:	Emory University (Atlanta, GA) Georgia Tech Research Corporation (Atlanta, GA)
Application Number:	13/447,246
Patent Claims:	1. A method of administering a drug to an eye of a patient, comprising: inserting a hollow microneedle into the eye at an insertion site, the microneedle having a tip end with an opening; and infusing over a period of time a fluid drug formulation comprising the drug, through the inserted microneedle and into the suprachoroidal space of the eye, wherein during the period the infused drug formulation flows within the suprachoroidal space away from the insertion site. 2. The method of claim 1, wherein during the period the infused fluid drug formulation flows at least 5 mm away from the insertion site. 3. The method of claim 1, wherein at least a portion of the fluid drug formulation reaches ocular tissue posterior to the equator of the eye during the period. 4. The method of claim 1, wherein the microneedle is inserted into the surface of the sclera at an angle of about 90 degrees. 5. The method of claim 1, wherein the tip end of the microneedle is inserted substantially to the base of the sclera without completely penetrating through the sclera. 6. The method of claim 1, wherein the tip end of the microneedle is inserted through the sclera into the suprachoroidal space without penetrating through the choroid. 7. The method of claim 1, wherein the fluid drug formulation comprises a suspension of microparticles or nanoparticles, the microparticles or nanoparticles comprising the drug. 8. The method of claim 1, wherein from about 10 .mu.L to about 200 .mu.L of the fluid drug formulation is infused. 9. The method of claim 1, wherein the suspension further comprises a physiologically acceptable aqueous vehicle. 10. The method of claim 1, wherein the fluid drug formulation comprises a formulation that undergoes a phase change after being infused into the suprachoroidal space. 11. The method of claim 1, wherein the step of infusing comprises driving the fluid drug formulation at an infusion pressure of at least 150 kPa. 12. The method of claim 1, wherein the step of infusing comprises driving the fluid drug formulation at an infusion pressure of at least 300 kPa. 13. The method of claim 1, wherein the microneedle has an effective length between 500 microns and 1000 microns. 14. The method of claim 1, wherein the microneedle has an effective length between 700 microns and 1000 microns. 15. The method of claim 1, wherein the microneedle has an effective length between 800 microns and 1000 microns. 16. The method of claim 1, wherein the portion of the microneedle that is inserted into the sclera has a maximum cross-sectional width or diameter of 400 microns. 17. The method of claim 1, wherein the microneedle is formed of metal and has a total effective length between 500 microns and 1000 microns, the microneedle comprising a cylindrical shaft having an outer diameter of between 200 microns and 400 microns, and a beveled tip less than about 400 microns in length. 18. The method of claim 1, wherein the microneedle extends substantially perpendicularly from a planar or convex base. 19. The method of claim 1, wherein the patient is in need of treatment of uveitis, glaucoma, diabetic macular edema, wet or dry age-related macular degeneration, choroidal neovascularization, or cytomegalovirus retinitis. 20. The method of claim 1, wherein the insertion site is at the equator of the eye. 21. The method of claim 1, wherein the insertion site is between the equator and the limbus of the eye. 22. The method of claim 1, wherein from about 10 .mu.L to about 500 .mu.L of the fluid drug formulation is infused. 23. The method of claim 1, wherein the fluid drug formulation flows circumferentially toward the posterior segment of the eye. 24. The method of claim 1, wherein the fluid drug formulation flows posterior to the equator of the eye during the injection. 25. The method of claim 1, wherein the drug comprises an oligonucleotide. 26. The method of claim 25, wherein the oligonucleotide is selected from an antisense oligonucleotide, therapeutic DNA, ribozyme, siRNA, RNAi or double stranded RNA. 27. The method of claim 1, wherein the drug is an antiviral agent. 28. The method of claim 27, wherein the antiviral agent is acyclovir, cidofovir, idoxuridine or an interferon. 29. The method of claim 1, wherein the drug is an analgesic. 30. The method of claim 1, wherein the drug is an anesthetic. 31. The method of claim 1, wherein the drug is a collagenase inhibitor. 32. The method of claim 1, wherein the drug is pegagtanib sodium, ranibizumab or bevacizumab. 33. The method of claim 1, further comprising dissolving a coating of a drug formulation off the hollow microneedle into the eye. 34. The method of claim 1, wherein the fluid drug formulation comprises an anesthetic. 35. The method of claim 33, wherein the coating of the drug formulation comprises an anesthetic. 36. The method of claim 34, wherein the anesthetic is amethocaine, lignocaine, oxbuprocaine or proxymetacaine. 37. The method of claim 35, wherein the anesthetic is amethocaine, lignocaine, oxbuprocaine or proxymetacaine. 38. The method of claim 36, wherein the anesthetic is lignocaine. 39. The method of claim 37, wherein the anesthetic is lignocaine.

Details for Patent 8,808,225

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		2026-05-02
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	02/26/2004		2026-05-02
Genentech, Inc.	LUCENTIS	ranibizumab	Injection	125156	06/30/2006		2026-05-02