Phase 2 Clinical Trial to Evaluate the Efficacy of Phentolamine Ophthalmic Solution and LowDose Pilo

Phase 2 Clinical Trial to Evaluate the Efficacy of Phentolamine Ophthalmic Solution and Low-Dose Pilocarpine for the Treatment of Presbyopia

2021

Author: Jay S. Pepose, MD, PhD, ABO

Contributors: Mina Sooch MBA, BEng, Konstantinos Charizanis PhD, MBA, Alan Meyer MBA, BEng, Charles Slonim MD, Eliot Lazar MD

Purpose:

The objective of this study is to evaluate the efficacy of a kit combination of Nyxol, or 0.75% phentolamine ophthalmic solution (POS), and low-dose pilocarpine for the temporary treatment of presbyopia. POS has shown in multiple Phase 2 trials a tolerable safety profile, significant reductions of pupil diameter, and improvements in near vision

Methods:

The VEGA-1 study is a Phase 2, multi-center, randomized, placebo-controlled, double-masked clinical trial. Subjects with distance-corrected near visual acuity (DCNVA) of 20/50 or worse will be randomized to receive either 0.75% POS or placebo vehicle with and without low-dose pilocarpine. The primary endpoint will be the percent of patients with at least 15 letters ETDRS (3 lines) or more of binocular DCNVA improvement relative to baseline on a standard near vision eye chart without loss of distance vision. Trial start-up activities are underway with first patient expected in 1Q21

Results:

Enrollment for the VEGA-1 study completed in May 2021 with 150 subjects enrolled across 17 sites. The primary endpoint will be the percent of patients with at least 15 letters ETDRS (3 lines) or more of binocular photopic DCNVA improvement relative to baseline on a standard near vision eye chart at 1 hour. Additional secondary endpoints include near/distance/intermediate visual acuity at multiple timepoints, effect of iris color, percentage of subjects with < 5="" letters="" of="" loss="" in="" distance="" visual="" acuity="" and="" measurements="" in="" pupil="" diameter="" over="" time.="" following="" data="" lock,="" topline="" efficacy="" and="" safety="" data="" will="" be="" analyzed="" and="" presented="" at="" the="" meeting.="" 5="" letters="" of="" loss="" in="" distance="" visual="" acuity="" and="" measurements="" in="" pupil="" diameter="" over="" time.="" following="" data="" lock,="" topline="" efficacy="" and="" safety="" data="" will="" be="" analyzed="" and="" presented="" at="" the="" />

Conclusions:

The results from this Phase 2 trial will define the clinical efficacy and safety profile of a kit combination of 0.75% POS and low-dose pilocarpine for further Phase 3 trials. This approach of POS and LDP may offer a potential new pharmacologic drop option for the treatment of presbyopia.