IP Library Granted Patent US 12,533,347
Granted Patent B2
US 12,533,347 · App. 18/369,737 · Granted Jan 27, 2026

Compositions and methods for storage stable ophthalmic drugs

Inventor: Gerald Horn (Highland Park, IL)
Assignee: LENZ THERAPEUTICS OPERATIONS, INC.
A61K31/439A61K47/02A61K47/12A61K47/14A61K47/183A61K47/186A61K47/20A61K47/22A61K47/26A61K47/38A61J1/165
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Quick Facts
Patent No.
US 12,533,347
App. No.
18/369,737
Granted
Jan 27, 2026
Kind
B2
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.

Claims (22)

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.

Assignments (2)
CHANGE OF NAME Recorded Apr 2, 2024
From: LENZ THERAPEUTICS, INC.
To: LENZ THERAPEUTICS OPERATIONS, INC.
Reel/Frame 066978/0082 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 13, 2023
From: HORN, GERALD
To: LENZ THERAPEUTICS, INC.
Reel/Frame 065857/0458 →
Continuity (6)
Continuation 18239087 · Aug 28, 2023
Continuation 17242398 · Apr 28, 2021
Continuation In Part 17069155 · Oct 13, 2020
Continuation In Part 16595789 · Oct 8, 2019
Provisional Application 62743720 · Oct 10, 2018
Related Publication 20240091207A1 · Mar 21, 2024
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