Abstract
Purpose :
In the VEGA-1 Phase 2b presbyopia clinical trial, 0.75% phentolamine ophthalmic solution (POS) in combination with low dose pilocarpine (LDP) had a tolerable safety profile and met its primary efficacy endpoint by improving near vision by 3 lines. This abstract describes a pre-specified secondary analysis evaluating the efficacy of POS alone for improving distance-corrected near visual acuity (DCNVA) by 3 lines in presbyopia patients.
Methods :
In the VEGA-1 trial, a Phase 2b, multi-center, randomized, placebo-controlled, double-masked clinical trial, a pre-specified secondary analysis evaluated the efficacy of POS alone for the treatment of presbyopia. Subjects with DCNVA of 20/50 or worse were randomized to receive POS vs placebo for 3-4 nights. The following morning at study visit 2, the percent of patients with ≥15 letters (3 lines) binocular photopic DCNVA improvement relative to baseline on an ETDRS chart in the POS and placebo arms were compared using logistic regression. We also assessed ≥ 10 letter (2 line) DCNVA improvement outcomes. Mean change in number of ETDRS letters read between treatment arms was compared using analysis of covariance. Percentage of subjects achieving DCNVA of 20/40 or better was also assessed.
Results :
After randomization, 73 and 75 subjects received POS and placebo, respectively. Twelve or more hours after treatment, 30% of subjects in the POS arm and 14% in the placebo arm had a ≥ 15 letter binocular DCNVA improvement (p=0.027). POS compared to placebo resulted in more subjects achieving DCNVA improvements of ≥ 10 letters (53% vs 28%; p=0.005) and ≥ 5 letters (75% vs 55%; p=0.01). Compared to baseline, POS conferred a mean 10.2 letter improvement in DCNVA, significantly more than the 5.8 letter improvement with placebo (p=0.0008). Forty-one (56%) patients treated with POS and 27 (36%) treated with placebo had DCNVA of 20/40 or better (p=0.014). POS demonstrated similar improvements in monocular DCNVA. POS showed a favorable safety profile with only few mild adverse events and no headaches.
Conclusions :
In this Phase 2b clinical trial, POS showed clinical efficacy to achieve a ≥15 letters improvement in DCNVA in presbyopia subjects. Given these results, advancement to Phase 3 trials is planned to evaluate the efficacy of POS alone and in combination with LDP for presbyopia.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.