Gemini I Phase 3 Agn-190584 Improves Intermediate Vision in Participants with Presbyopia

Gemini I Phase 3: Agn-190584 Improves Intermediate Vision in Participants with Presbyopia

2021

Author: William C. Christie, MD, ABO

Contributors: Joseph Tauber MD, Fangqiu Zhang MS, Tudor Tepelus PhD, Eleonora Safyan PhD, Gary Jerkins MD

Purpose:

The GEMINI I phase 3 study evaluated a secondary efficacy endpoint of intermediate vision of AGN-190584 vs. vehicle in participants with presbyopia. Tasks that require intermediate vision are performed at a viewing distance of 20-40 inches. Distance-corrected intermediate visual acuity (DCIVA) measured at 66 cm (~26 inches) was evaluated.

Methods:

GEMINI I is a multicenter, double-masked, randomized, vehicle-controlled, phase 3 study. Participants with presbyopia, age 40 to 55 years, received topical AGN-190584 or vehicle once daily, bilaterally, for 30 days. The intent-to-treat population (ITT) included 323 participants. Study visits: screening, Day 1 (baseline), 3, 7, 14, and 30. Photopic, high contrast DCIVA was measured binocularly at 0, 1, 3, 6, 8, and 10 hours at Day 30. LogMar charts were used for DCIVA measurement. AGN-190584 (pilocarpine 1.25%) is an optimized formulation of pilocarpine designed for presbyopia, enhanced with a proprietary vehicle to reduce vision blur and discomfort following topical administration.

Results:

The mean (SD) age was 49.6 (3.53) years in the ITT population. A secondary efficacy endpoint of change from baseline in photopic DCIVA letters at Day 30, Hour 3 comparing AGN-190584 and vehicle was met (p<0.05) and="" this="" difference="" was="" maintained="" through="" 10="" hours=""><0.05). agn-190584,="" increased="" the="" depth="" of="" focus="" and="" had="" statistical="" and="" clinically="" significant="" dciva="" improvements="" of="" ≥2="" line="" through="" 10="" hours=""><0.05) without="" loss="" in="" distance="" va="" compared="" to="" vehicle.="" agn-190584="" was="" well-tolerated="" and="" had="" an="" acceptable="" safety="" profile.="" gemini="" i="" met="" its="" primary="" endpoint="" (proportion="" of="" participants="" gaining="" ≥="" 3="" lines="" in="" mesopic="" distance="" corrected="" near="" visual="" acuity="" (dcnva)="" at="" day="" 30,="" hour="" 3,=""><0.05).>

Conclusions:

AGN-190584 met its primary and secondary endpoint of near and intermediate vision improvement, respectively. AGN-190584 was well-tolerated and provides clinically significant improvements in both near and intermediate vision in participants with presbyopia.