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AGN-190584 appears safe and effective in managing presbyopia

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AGN-190584 (Allergan) was found to be safe and effective through 30 days, according to the results of a phase 3 clinical trial. The investigational pilocarpine formulation improved near and intermediate vision on day 30 for up to 10 hours after administration.

Bilaterally administered of AGN-190584 or the AGN-190584 formulation vehicle was given to 323 participants (163 patients and 160 patients, respectively) once daily for 30 days.

On day 30, the percentage of participants with an improvement of ≥3 lines in mesopic DCNVA was as follows:

Hour 3
AGN-190584 group: 30.7% (50 of 163)
Vehicle group: 8.1% (13 of 160)

Hour 6
AGN-190584 group: 18.4% (30 of 163)
Vehicle group: 8.8% (14 of 160)

At house 8, between-group difference in ≥3 of mesopic DCNVA gains was not statistically significant. However, prespecified clinically relevant outcome measures showed AGN-190584 was superior to vehicle in least-squares mean (SE) mesopic DCNVA change from baseline at hour 8 and photopic distance-corrected intermediate visual acuity at hour 8 and hour 10.

Of the participants with mesopic DCNVA improvement of ≥3 lines at hour 3, none had losses of > 5 letters in mesopic, high-contrast, binocular-corrected distance visual acuity.

At 15 minutes, the onset of effect was evident.

Waring GO, Price FW, Wirta D, et al. Safety and Efficacy of AGN-190584 in Individuals With Presbyopia: The GEMINI 1 Phase 3 Randomized Clinical Trial. JAMA Ophthalmol. Published online March 03, 2022. doi:10.1001/jamaophthalmol.2022.0059