Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia

Summary

A study to evaluate the efficacy, safety, and pharmacokinetics of pilocarpine hydrochloride (HCl) ophthalmic solution (AGN-190584) when administered bilaterally, once daily for 30 days in participants with presbyopia.

Timeline

Start

2018-12-21

Primary completion

2019-10-31

Completion

2019-10-31

Outcome

Met primary endpoint

registry analysis (superiority test); Vehicle vs Pilocarpine HCl Ophthalmic Solution; p <0.0001; Percentage Difference 22.5 (95% CI 14.3 to 30.8) NCT03804268 ↗

paper GEMINI 1 met its primary and key secondary efficacy end points. PMID 35238902 ↗

Publications

• Lievens CW, Hom MM, McLaurin EB, Yuan J, Safyan E, Liu H. Pilocarpine HCl 1.25% for treatment of presbyopia after laser vision correction: pooled analysis of two phase 3 randomized trials (GEMINI 1 and 2). J Cataract Refract Surg. 2024 Jan 1;50(1):57-63. doi: 10.1097/j.jcrs.0000000000001313.
• Westheimer G. Topical Review: Pilocarpine-induced Miosis as Help for Early Presbyopes? Optom Vis Sci. 2022 Aug 1;99(8):632-634. doi: 10.1097/OPX.0000000000001924. Epub 2022 Jul 14.
• Waring GO 4th, Price FW Jr, Wirta D, McCabe C, Moshirfar M, Guo Q, Gore A, Liu H, Safyan E, Robinson MR. Safety and Efficacy of AGN-190584 in Individuals With Presbyopia: The GEMINI 1 Phase 3 Randomized Clinical Trial. JAMA Ophthalmol. 2022 Apr 1;140(4):363-371. doi: 10.1001/jamaophthalmol.2022.0059.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pilocarpine	Unknown	1.25 %	Topical

Indications