Claims for Patent: 12,128,036

Summary for Patent: 12,128,036

Title:	Compositions and methods for storage stable ophthalmic drugs
Abstract:	The present invention is related to methods of stabilizing an ophthalmic drug by adding a surfactant and a viscosity enhancer to the ophthalmic drug to create a composition wherein the composition has a viscosity of about 25 centipoise or less at a shear rate of 1/1000 per second at 25 degrees Celsius and a viscosity of about 70 centipoise or more at shear rate of 1 per second at 25 degrees Celsius, filling the composition into a container; and storing the container at a temperature from about 2 degrees Celsius to about 25 degrees Celsius. The present invention is further directed to a container prepared by the methods of the present invention.
Inventor(s):	Gerald Horn
Assignee:	Lenz Therapeutics Operations Inc
Application Number:	US18/239,087
Patent Claims:	1. A method for treating presbyopia in a subject in need thereof, the method comprising: (a) providing an aqueous ophthalmological solution comprising aceclidine, wherein the aqueous ophthalmological solution does not comprise a cycloplegic agent; (b) storing the aqueous ophthalmological solution in a container having a headspace at a temperature from about 2 degrees Celsius to about 8 degrees Celsius for at least 7 months to provide a stored aqueous ophthalmological solution; and (c) administering the stored aqueous ophthalmological solution to the subject in need thereof, wherein upon administration, the stored aqueous ophthalmological solution comprises at least 90% of the aceclidine that the aqueous ophthalmological solution comprised at the onset of the storing; thereby treating the presbyopia in the subject. 2. The method of claim 1, wherein the aqueous ophthalmological solution is stored for at least 12 months. 3. The method of claim 2, wherein the aqueous ophthalmological solution is stored for at least 18 months. 4. The method of claim 3, wherein the aqueous ophthalmological solution is stored for at least 24 months. 5. The method of claim 1, wherein the aqueous ophthalmological solution has a viscosity of about 1 centipoise (cp) to about 25 cps at a high shear of blinking and a viscosity of about 50 cps to about 200 cps at a low shear between blinks. 6. The method of claim 1, wherein the aqueous ophthalmological solution comprises a pH from about 4.0 to about 8.0. 7. The method of claim 1, wherein the aceclidine is at a concentration from about 0.25% to about 4.0% w/v aceclidine, wherein w/v denotes weight by total volume of the aqueous ophthalmological solution. 8. The method of claim 7, wherein the aceclidine is at a concentration from about 0.50% to about 1.90% w/v aceclidine, wherein w/v denotes weight by total volume of the aqueous ophthalmological solution. 9. The method of claim 8, wherein the aceclidine is at a concentration from about 1.65% to about 1.85% w/v aceclidine, wherein w/v denotes weight by total volume of the aqueous ophthalmological solution. 10. The method of claim 1, wherein the aqueous ophthalmological solution further comprises a surfactant. 11. The method of claim 1, wherein the aqueous ophthalmological solution further comprises a viscosity enhancer. 12. The method of claim 11, wherein the aceclidine remains in the aqueous ophthalmological solution for at least 7 additional months in comparison to an aqueous ophthalmological solution not comprising the viscosity enhancer. 13. The method of claim 1, wherein the aqueous ophthalmological solution is stored for 7 months to 18 months. 14. The method of claim 1, wherein the aqueous ophthalmological solution is stored for 7 months. 15. The method of claim 1, wherein the aqueous ophthalmological solution is stored for about 12 months. 16. The method of claim 1, wherein the aqueous ophthalmological solution is stored for about 15 months. 17. The method of claim 1 wherein the aqueous ophthalmological solution further comprises a cryoprotectant. 18. The method of claim 1, wherein the aqueous ophthalmological solution further comprises a polyol. 19. The method of claim 1, wherein the aqueous ophthalmological solution further comprises mannitol. 20. The method of claim 1, wherein a cycloplegic agent is not administered to the subject.