AbbVie's Investigational Eye Drop AGN-190584 Shows Positive Phase 3 Results for Presbyopia Treatment

Today, Allergan, an AbbVie company, announced the full results from the Phase 3 GEMINI 1 clinical trial evaluating its investigational ophthalmic solution AGN-190584 (pilocarpine 1.25%) for the treatment of presbyopia. The press release stated that, if approved by the U.S. FDA, it could become the first eye drop therapy for presbyopia.

Presbyopia affects nearly 2 billion people worldwide, and there is currently no effective pharmacological solution available for patients. Currently, patients are limited to wearing reading glasses, which is inconvenient for many. Undergoing irreversible invasive surgery carries inherent procedural risks. Therefore, there is a strong interest among patients in an effective and safe pharmaceutical treatment for presbyopia.

AGN-190584 is an innovatively optimized ophthalmic formulation of pilocarpine. Its primary mechanism of action is pupillary constriction, which enhances depth of focus to improve near and intermediate vision, while maintaining the pupil's normal response to varying lighting conditions.

The GEMINI 1 trial evaluated the efficacy and safety of AGN-190584 in 323 participants. Participants received the eye drops once daily for a 30-day treatment period. Trial results demonstrated that AGN-190584 met the primary endpoint; on Day 30, a greater proportion of patients treated with AGN-190584 achieved an improvement of three or more lines in distance-corrected near visual acuity (DCNVA) compared to placebo. The results further indicated that AGN-190584 had an onset of action within 15 minutes of administration, with effects lasting up to 6 hours.

Based on the results of the GEMINI 1 and GEMINI 2 trials, AbbVie has submitted a New Drug Application (NDA) for AGN-190584 to the U.S. FDA. It is currently under review, and the FDA is expected to issue a decision by the end of this year.

Note: The original text has been abridged.

References:

[1] New Data Presented on the Safety and Efficacy of Investigational AGN-190584 as a Potential Novel Treatment for Presbyopia, a Common and Progressive Eye Condition. Retrieved July 25, 2021, from https://www.prnewswire.com/news-releases/new-data-presented-on-the-safety-and-efficacy-of-investigational-agn-190584-as-a-potential-novel-treatment-for-presbyopia-a-common-and-progressive-eye-condition-301339937.html

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