Claims for Patent: 11,398,306

Summary for Patent: 11,398,306

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:	US17/091,607
Patent Claims:	1. A method of delivering a microdosage volume of a composition comprising at least one medicament as an ejected stream of droplets to an eye of a subject in need thereof, the method comprising: (a) generating an ejected stream of droplets of the composition comprising the at least one 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; and an ejector mechanism fluidly coupled to the reservoir, the ejector mechanism comprising an 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 droplet size of at least about 15 microns and an average initial ejecting velocity between about 0.5 m/s to about 20 m/s; and (b) delivering said ejected stream of droplets to said eye of the 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 microdosage volume of the composition comprising said medicament of less than 15 μl to said eye; and wherein the at least one medicament is selected from the group consisting of travoprost, latanoprost, bimatoprost, dorzolamide hydrochloride, timolol maleate, brimonidine tartrate, brinzolamide, phenylephrine hydrochloride, tropicamide, and a combination of two or more thereof. 2. The method according to claim 1, wherein said composition is an aqueous solution. 3. The method according to claim 1, wherein said composition is an oil/water emulsion. 4. The method according to claim 3, wherein said oil in said oil/water emulsion comprises glycerin, castor oil, or polysorbate 80. 5. The method according to claim 1, wherein said droplets have an average droplet size in the range of about 30 microns to about 60 microns. 6. The method according to claim 1, wherein said droplets have an average initial ejecting velocity between about 1 m/s to about 10 m/s. 7. The method according to claim 1, wherein said ejected stream of droplets is delivered to the eye of the subject in need thereof for the treatment of an eye condition, an eye disorder, an eye indication, or eye discomfort. 8. The method according to claim 1, wherein the microdosage volume of the composition is from about 2 μl to about 10 μl. 9. The method according to claim 1, wherein said composition comprises each of said at least one medicament at a concentration of from about 0.0001% to about 5%. 10. The method according to claim 1, wherein said composition comprises each of said at least one medicament at a concentration of from about 0.001% to about 0.5%. 11. The method according to claim 1, wherein said composition comprises at least one of said at least one medicament at a concentration of about 1%. 12. The method according to claim 1, wherein said composition comprises at least one of said at least one medicament at a concentration of about 2.5%. 13. The method according to claim 1, wherein said at least one medicament is selected from the group consisting of tropicamide, phenylephrine hydrochloride, and a combination thereof. 14. The method according to claim 13, wherein said composition comprises each of said at least one medicament at a concentration of from about 0.0001% to about 5%. 15. The method according to claim 13, wherein said composition comprises each of said at least one medicament at a concentration of from about 0.001% to about 0.5%. 16. The method according to claim 13, wherein said composition comprises at least one of said at least one medicament at a concentration of about 1%. 17. The method according to claim 13, wherein said composition comprises at least one of said at least one medicament at a concentration of about 2.5%. 18. The method according to claim 1, wherein said at least one medicament is tropicamide and phenylephrine hydrochloride. 19. The method according to claim 18, wherein said composition comprises tropicamide at a concentration of about 1%. 20. The method according to claim 18, wherein said composition comprises phenylephrine hydrochloride at a concentration of about 2.5%. 21. A method of delivering droplets comprising a composition to an eye of a subject in need thereof, the method comprising: (a) generating the droplets comprising the composition via a piezoelectric actuated ejection device, the ejection device comprising: (i) a housing; (ii) a reservoir disposed within the housing for receiving a volume of the composition; and (iii) an ejector mechanism fluidly coupled to the reservoir, the ejector mechanism comprising an ejector plate comprising 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 generate droplets from the composition upon actuation, wherein the droplets have an average droplet size of at least 15 microns and an average initial ejecting velocity between about 0.5 m/s to about 20 m/s; and (b) delivering the droplets to the eye of the subject; wherein the droplets provide a total volume of less than 15 μl of the composition to the eye; and wherein the composition comprises travoprost, latanoprost, bimatoprost, dorzolamide hydrochloride, timolol maleate, brimonidine tartrate, brinzolamide, phenylephrine hydrochloride, tropicamide, or a combination of two or more thereof. 22. The method of claim 21, wherein the composition comprises tropicamide. 23. The method of claim 21, wherein the composition comprises tropicamide at a concentration of about 1%. 24. The method of claim 21, wherein the composition comprises phenylephrine hydrochloride. 25. The method of claim 21, wherein the composition comprises phenylephrine hydrochloride at a concentration between about 2% and about 3%. 26. The method of claim 21, wherein the composition comprises phenylephrine hydrochloride at a concentration of about 2.5%. 27. The method of claim 21, wherein the composition comprises tropicamide and phenylephrine hydrochloride. 28. The method of claim 21, wherein between about 85% to about 100% of the ejected mass of the droplets are deposited on the eye. 29. The method according to claim 1, wherein the composition is a suspension.