Abstract
Purpose :
The objective of this study is to evaluate the efficacy of a combination of 0.75% phentolamine ophthalmic solution (POS) and 0.4% low-dose pilocarpine (LDP) to improve distance-corrected intermediate visual acuity (DCIVA) in patients with presbyopia.
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 were randomized to receive either 0.75% POS or placebo vehicle in the evening, followed with and without a morning dose of 0.4% LDP. DCIVA was assessed at multiple time points after a single combination treatment. Logistic regression models comparing POS+LDP to each treatment, with treatment and light/dark irides as factors and baseline DCIVA as a covariate was used to compare the proportion of patients with 5-letter and 10-letter improvements in DCIVA. Mean improvements in DCIVA were also assessed.
Results :
Of the 150 participants included in this clinical trial (mean age 53.1 years, 72% female, 89% White), 43 were randomized to placebo alone, 30 to POS alone, 43 to POS+LDP, and 30 to LDP alone. Subjects treated with POS+LDP had a mean (SD) 9.6 (5.7) letter improvement in DCIVA from baseline at 1 hour vs 4.5 (6.7) letters with placebo (p<0.0001). This improvement was seen in those with both irides: light 10.4 (5.7) letters; dark 8.4 (5.6) letters. At 6 hours, POS+LDP conferred a 7.1 (6.0) letter improvement from baseline, significantly more than placebo (4.0 [6.3], p<0.0001). LDP+POS yielded a greater proportion of patients with a ≥ 10-letter improvement in DCIVA than placebo at 1 hour (49% vs 27%, p=0.027). A greater proportion of patients treated with POS+LDP had ≥ 5 letter improvement in DCIVA at 1 hour compared to placebo (86% vs 58%, OR: 5.2, p=0.004) and at 6 hours (72% vs 49%, OR: 3.0, p=0.027).
Conclusions :
In this Phase 2 clinical trial, 0.75% POS and 0.4% LDP significantly improved DCIVA in subjects with presbyopia at 1 hour, with durable results through 6 hours. Phase 3 studies are planned to advance POS+LDP for a potential treatment for presbyopia.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.