US-20260124178-A1 - PRESBYOPIA TREATMENTS

Abstract

Described herein are methods and compositions for the treatment of ocular conditions and for the improvement of vision parameters using pharmaceutically acceptable ophthalmic pilocarpine formulations. A nonlimiting example of an ocular condition that may be treated with the methods and compositions disclosed herein is presbyopia.

Inventors

• Michael R. Robinson
• Mohammed DIBAS
• Jaya Giyanani
• Anuradha Gore
• Sungwook Lee
• Haixia Liu
• Aileen Morgan
• Jihao Zhou

Assignees

• ALLERGAN, INC.

Dates

Publication Date

20260507

Application Date

20250905

Claims (6)

1. 1 . A method of treating an ocular condition in a patient in need thereof, comprising administering to the patient a pharmaceutically acceptable ophthalmic composition comprising pilocarpine hydrochloride at a concentration from 1.0 to 1.5% w/v, wherein the formulation is administered topically to at least one eye of the patient, and wherein the ocular condition is selected from the group consisting of presbyopia, hyperopia, mydriasis, anisocoria, accommodative esotropia, myopia, and astigmatism.
2. 2 . A method of improving at least one vision parameter in a patient in need thereof, comprising administering to the patient a pharmaceutically acceptable ophthalmic composition comprising pilocarpine hydrochloride at a concentration from 1.0 to 1.5% w/v, wherein the formulation is administered topically to at least one eye of the patient, and wherein the at least one vision parameter is selected from the group consisting of near vision acuity, intermediate vision acuity, distance vision acuity, night vision, day vision, glare, and light scattering.
3. 3 . A method for improvement of near vision in a patient with presbyopia in need thereof, comprising administering to an eye of the patient a pharmaceutically acceptable ophthalmic composition comprising pilocarpine hydrochloride at a concentration from 1.0 to 1.5% w/v.
4. 4 . The method of claim 1 , wherein the ocular condition is presbyopia.
5. 5 . The method of claim 1 , wherein the ocular condition is hyperopia.
6. 6 . The method of claim 1 , wherein the ocular condition is mydriasis.

Description

PRIORITY This application is a continuation of U.S. patent application Ser. No. 18/621,624, filed Mar. 29, 2024, which is a continuation of U.S. patent application Ser. No. 18/507,354, filed Nov. 13, 2023, now abandoned, which is a continuation of U.S. patent application Ser. No. 17/647,813, filed Jan. 12, 2022, now abandoned, which is a continuation of U.S. patent application Ser. No. 16/791,039, filed Feb. 14, 2020, now U.S. Pat. No. 11,285,134, issued Mar. 29, 2022, which is a continuation of U.S. patent application Ser. No. 16/393,175, filed Apr. 24, 2019, now U.S. Pat. No. 10,610,518, issued Apr. 7, 2020, which claims the benefit of priority from U.S. Provisional Application 62/662,144, filed Apr. 24, 2018, U.S. Provisional Application 62/780,117, filed Dec. 14, 2018, and U.S. Provisional Application 62/790,957, filed Jan. 10, 2019, the disclosures of which are hereby incorporated in their entireties herein by reference. BACKGROUND Presbyopia and other visual disorders have long been treated primarily with optical lenses and other such mechanical devices. As discussed in further detail herein, it would be advantageous to provide an alternative treatment that would avoid the use of such devices and the various disadvantages that these entail. Cholinergic agonists, such as pilocarpine, have been used to lower intraocular pressure (“IOP”) so as to treat primary open angle glaucoma. Such cholinergic agonists were a mainstay for treatments that sought to lower IOP until the introduction of timolol in 1978. In the subsequent decades, and with the introduction of topical carbonic anhydrase inhibitors, alpha agonists, and prostaglandin agonists, pilocarpine became prescribed less often since the newer drugs had a much lower incidence of side effects such as reduced visual acuity and ocular discomfort (Allingham et al., Shields' Textbook of Glaucoma, 5th edition, Lippincott Williams & Wilkins (Philadelphia), 2005, pp. 501-503). BRIEF SUMMARY Described herein are compositions and methods for improving vision using pilocarpine. In some embodiments, there is provided a method of treating an ocular condition in a patient comprising administering to the patient an ophthalmic composition comprising pilocarpine hydrochloride. In one preferred embodiment, there is provided a method of treating an ocular condition in a patient in need thereof, comprising administering to the patient a pharmaceutically acceptable ophthalmic composition comprising pilocarpine hydrochloride at a concentration from 1.0 to 1.5% w/v, wherein the formulation is administered topically to at least one eye of the patient, and wherein the ocular condition is selected from the group consisting of presbyopia, hyperopia, mydriasis, anisocoria, accommodative esotropia, myopia, and astigmatism. In another preferred embodiment, there is provided a method of improving at least one vision parameter in a patient in need thereof, comprising administering to the patient a pharmaceutically acceptable ophthalmic composition comprising pilocarpine hydrochloride at a concentration from 1.0 to 1.5% w/v, wherein the formulation is administered topically to at least one eye of the patient, and wherein the at least one vision parameter is selected from the group consisting of near vision acuity, intermediate vision acuity, distance vision acuity, night vision, day vision, glare, and light scattering. In a further preferred embodiment, there is provided a method for improvement of near vision in a patient with presbyopia in need thereof, comprising administering to an eye of the patient a pharmaceutically acceptable ophthalmic composition comprising pilocarpine hydrochloride at a concentration from 1.0 to 1.5% w/v. In some embodiments, the ocular condition is presbyopia. In some embodiments, the ocular condition is hyperopia. In some embodiments, the ocular condition is mydriasis. In some embodiments, the vision parameter is near vision acuity. In some embodiments, the vision parameter is intermediate vision acuity. In some embodiments, the vision parameter is distance vision acuity. In some embodiments, the vision parameter is night vision. Additional embodiments provide for the method resulting in an at least 3-line improvement from baseline under the condition of mesopic, high contrast UNVA. In some embodiments, the method results in an at least 2-line improvement from baseline under the condition of mesopic, high contrast UNVA. In some embodiments, the method results in an increase in the average letter change from baseline under the condition of mesopic, high contrast UNVA. In some embodiments, the method results in an at least 2-line improvement from baseline under the condition of photopic, high contrast UNVA. In some embodiments, the method results in an at least 2-line improvement from baseline under the condition of photopic, high contrast UDVA. In some embodiments, the method results in an at least 3-line improvement from baseline under the condition of me