Purpose:

To evaluate the safety and efficacy of an optimized formulation of 1.25% pilocarpine (AGN-190584) compared to vehicle in participants with presbyopia. We report the proportion of gaining 3 lines or more in distance-corrected near visual acuity (DCNVA) and achieving functional visual acuity (20/40 or better binocular DCNVA) at day 30, hour 3.

Methods:

In this 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. Study visits included screening, day 1 (baseline), 3, 7, 14, and 30. DCNVA was assessed binocularly in mesopic and photopic conditions. The proportion of participants gaining ≥ 3 lines in DCNVA, achieving 20/40 or better binocular DCNVA, and safety profile were assessed.

Results:

In all, 323 participants (88 males, 235 females) were evaluated. Mean (SD) age was 49.6 (3.53) years. The primary efficacy endpoint, proportion of participants gaining 3 lines or more in mesopic DCNVA at day 30, hour 3, was met with a significantly higher responder rate in the AGN-190584 group (22.5%, p < 0.0001)="" compared="" with="" vehicle.="" no="" responders="" had="" cdva="" (corrected="" distance="" visual="" acuity)="" loss="" of="" /> 5 letters and AGN-190584 was tolerable and safe. The proportion of participants achieving 20/40 or better photopic binocular DCNVA was significantly higher in the AGN-190584 group (12.6%, p = 0.0171) compared with vehicle.

Conclusions:

An optimized formulation of 1.25% pilocarpine with proprietary vehicle applied once a day bilaterally, was found to be statistically superior in efficacy compared to vehicle, safe and well-tolerated. This phase 3 study met its primary endpoint and demonstrated improvement in near and functional vision for 30 days without impairing distance vision.