Claims for Patent: 12,533,347

Summary for Patent: 12,533,347

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:	US18/369,737
Patent Claims:	1. A method of treating presbyopia in a subject, comprising: (a) storing an aqueous ophthalmological composition in a container at a temperature from about 2 degrees Celsius to about 8 degrees Celsius, thereby providing a stored aqueous ophthalmological composition; and (b) administering the stored aqueous ophthalmological composition to the subject, thereby treating the presbyopia in the subject; wherein the aqueous ophthalmological composition comprises aceclidine, lacks a cycloplegic agent, and is configured within the container, wherein the container comprises: (i) a closure; (ii) a vessel; (iii) the aqueous ophthalmological composition; and (iv) a headspace between the aqueous ophthalmological composition and the closure; wherein the closure is configured to prevent the stored aqueous ophthalmological composition from exiting the vessel; wherein when the container is stored at the temperature from about 2 degrees Celsius to about 8 degrees Celsius for at least 7 months, wherein the stored aqueous ophthalmological composition comprises at least 90% of the aceclidine that the composition comprised at the onset of storing; and wherein when the container is stored at the temperature from about 2 degrees Celsius to about 8 degrees Celsius for at least 7 months, and wherein the stored aqueous ophthalmological composition is suitable for treating presbyopia after the storing. 2. The method of claim 1, wherein when the container is stored at the temperature from about 2 degrees Celsius to about 8 degrees Celsius for at least 12 months, wherein the stored aqueous ophthalmological composition comprises at least 90% of the aceclidine that the aqueous ophthalmological composition comprised at the onset of storing. 3. The method of claim 1, wherein when the container is stored at the temperature from about 2 degrees Celsius to about 8 degrees Celsius for at least 18 months, wherein the stored aqueous ophthalmological composition comprises at least 90% of the aceclidine that the aqueous ophthalmological composition comprised at the onset of storing. 4. The method of claim 1, wherein when the container is stored at the temperature from about 2 degrees Celsius to about 8 degrees Celsius for at least 24 months, wherein the stored aqueous ophthalmological composition comprises at least 90% of the aceclidine that the aqueous ophthalmological composition comprised at the onset of storing. 5. The method of claim 1, wherein the aqueous ophthalmological composition has a viscosity of about 1 centipoise (cp) to about 25 cps at a high shear rate of blinking and a viscosity of about 50 cps to about 200 cps at a low shear rate between blinks. 6. The method of claim 1, wherein the aqueous ophthalmological composition has a pH from about 4.0 to about 8.0. 7. The method of claim 6, wherein the pH is from about 5.0 to about 7.0. 8. The method of claim 1, wherein the aceclidine is at a concentration from about 0.25% to about 4.0% w/v, wherein w/v denotes weight by total volume of the aqueous ophthalmological composition. 9. The method of claim 8, wherein the aceclidine is at a concentration from about 0.25% to about 2.0% w/v, wherein w/v denotes weight by total volume of the aqueous ophthalmological composition. 10. The method of claim 9, wherein the aceclidine is at a concentration from about 0.5% to about 1.9% w/v, wherein w/v denotes weight by total volume of the aqueous ophthalmological composition. 11. The method of claim 1, wherein the aqueous ophthalmological composition further comprises a surfactant. 12. The method of claim 1, wherein the aqueous ophthalmological composition further comprises a viscosity agent.