Claims for Patent: 10,839,960

Summary for Patent: 10,839,960

Title:	Ophthalmic drug delivery
Abstract:	The present invention includes and provides a method of delivering a medicament to an eye of a subject in need thereof a solution, the method comprising: (a) providing droplets containing the medicament with a specified average size and average initial ejecting velocity; and (b) delivering the medicament to the eye, where the droplets deliver a percentage of the ejected mass of the droplets to the eye.
Inventor(s):	Bernard L. Ballou, JR., Mark Packer, Russell John Mumper, Tsontcho Ianchulev
Assignee:	Eyenovia Inc
Application Number:	US16/113,231
Patent Claims:	1. A method of providing a microdosage volume of a composition comprising a medicament to an eye of a subject in need thereof as an ejected stream of droplets, the method comprising: (a) generating an ejected stream of droplets of a composition comprising a medicament via a piezoelectric actuated ejection device, the ejection device comprising: a housing; a reservoir disposed within the housing for receiving a volume of said composition; an ejector mechanism comprising an ejector plate having a first surface coupled to a fluid delivery area of the reservoir, the ejector plate including a plurality of openings formed through its thickness; and a piezoelectric actuator coupled to the ejector plate, the actuator being operable to oscillate the ejector plate at a frequency to thereby generate the ejected stream of droplets upon actuation; wherein said droplets have an average ejecting droplet size of between about 20 microns and about 100 microns in diameter and an average initial droplet ejecting velocity of between about 0.5 m/s to about 20 m/s; and (b) delivering said ejected stream of droplets to an eye of a subject in need thereof, wherein between about 85% to about 100% of the ejected mass of said droplets are deposited on the eye; wherein said droplets provide a total volume of the composition comprising said medicament of less than about 10 μl to said eye; and wherein said composition comprises said medicament at a concentration of from about 0.0001% to about 5%. 2. The method according to claim 1, wherein said droplets provide a total volume of the composition comprising said medicament of between about 2 μl to about 10 μl to said eye. 3. The method according to claim 1, wherein said composition comprises said medicament at a concentration of from about 0.001% to about 0.5%. 4. The method according to claim 1, wherein said composition comprises said medicament at a concentration of about 1%. 5. The method according to claim 1, wherein said composition comprises said medicament at a concentration of about 2.5%. 6. The method according to claim 1, wherein said composition is delivered in an aqueous droplet solution. 7. The method according to claim 1, wherein said composition is delivered in an oil/water emulsion droplet. 8. The method according to claim 7, wherein said oil in said oil/water emulsion droplet is a glycerin, a castor oil, or a polysorbate 80 mixture. 9. The method according to claim 1, wherein said medicament is a glaucoma medicament. 10. The method according to claim 1, wherein said medicament is an antibiotic. 11. The method according to claim 1, wherein said average droplet ejecting size is in the range of about 30 microns to about 60 microns. 12. The method according to claim 1, wherein said average droplet initial ejecting velocity is between about 1 m/s to about 10 m/s. 13. The method according to claim 1, said medicament is selected from the group consisting of ranibizumab antibody FAB, VEGF Trap fusion molecule, microplasmin enzyme, and bevacizumab. 14. The method according to claim 1, wherein said medicament comprises a medicament selected from the group consisting of carboxymethylcellulose sodium, tetrahydrozoline HCl, pheniramine maleate, ketotifen fumarate, oxymetazoline HCl, naphazoline HCl, pheniramine maleate, moxifloxacin hydrochloride, bromfenac, proparacaine hydrochloride, difluprednate, gatifloxacin, travoprost, bepotastine besilate, gatifloxacin, loteprednol etabonate, timolol ophthalmic, olopatadine hydrochloride, phenylephrine hydrochloride, levofloxacin, ketorolac tromethamine, latanoprost, bimatoprost BAK free latanoprost, tropicamide, and any combination thereof. 15. The method according to claim 1, wherein said medicament comprises a medicament selected from the group consisting of sodium carboxymethylcellulose, hydroxypropyl methylcellulose, tetrahydrozoline HCl, propylene glycol, zinc sulfate, dorzolamide HCl-timolol maleate, azithromycin, brimonidine tartrate, nepafenac, brinzolamide, besifloxacin, dorzolamide HCl, prenisone acetate, loteprednol etabonate, tobramycin/dexamethasone, cyclosporine, and any combination thereof. 16. The method according to claim 1, wherein said medicament is selected from the group consisting of travoprost, timolol ophthalmic, latanoprost, bimatoprost, dorzolamide HCl timolol maleate, brimonidine tartrate, brinzolamide, dorzolamide HCl, BAK free latanoprost, phenylephrine hydrochloride, tropicamide, and any combination thereof. 17. The method according to claim 1, wherein said ejected stream of droplets of a composition comprising a medicament is delivered to an eye of a subject in need thereof for the treatment of an eye condition, disorder, indication, or discomfort. 18. The method according to claim 1, wherein said medicament comprises a medicament selected from the group consisting of tropicamide, phenylephrine hydrochloride, and any combination thereof. 19. The method according to claim 18, wherein said composition comprises said medicament at a concentration of about 1%. 20. The method according to claim 18, wherein said composition comprises said medicament at a concentration of about 2.5%.