Phentolamine improved distance-corrected near visual acuity
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SAN DIEGO — Phentolamine with and without low-dose pilocarpine significantly improved distance-corrected near visual acuity without compromising distance vision, according to a poster presented at Academy 2022.
Mitch Ibach, OD, of Vance Thompson Vision, and colleagues conducted a phase 2, multicenter, randomized, placebo-controlled, double-masked, 5-day clinical trial to evaluate Nyxol (0.75% phentolamine ophthalmic solution, Ocuphire Pharma) alone and in combination with 0.4% low-dose pilocarpine for improving distance-corrected near visual acuity (DCNVA) in patients with presbyopia.
Researchers enrolled 147 participants, aged 40 to 65 years, with DCNVA of 20/50 or worse. Seventy-three received one drop of 0.75% phentolamine, and 74 received placebo in the evening. Twelve hours later, 29% in the treatment arm and 12% in the placebo arm had at least a 15-letter binocular DCNVA improvement, losing no more than five letters of distance vision (P = .024), according to the study.
“Durability [of Nyxol] is up to 18 hours,” study co-author Ronil Patel, MS, vice president of business development and market strategy at Ocuphire Pharma, told Healio. “At 24 hours, the pupil is still 1 mm smaller than baseline.”
“Fifty-three percent gained functional near vision,” Ibach told Healio, compared with 29% with placebo (P = .006).
Patel added that “56% moved into 20/40 or better at 12 hours with Nyxol alone.”
Forty-three of the 73 participants randomized to phentolamine and 31 of those randomized to placebo then received low-dose pilocarpine in the morning after the 12-hour measurement. According to the study, 1 hour after dosing, 61% of those in the treatment arm vs. 28% in the placebo arm (P = .004) had at least a 15-letter improvement in DCNVA from baseline and lost no more than five letters of distance vision.
Ibach told Healio that the investigators observed no serious adverse events.
“You take [Nyxol] the night before instead of in the morning,” he said. “You may get hyperemia, but it happens while you sleep. No subjects experienced headache.”
The researchers concluded that phentolamine alone and in combination with low-dose pilocarpine had a favorable safety profile and significantly improved DCNVA in participants without compromising their distance vision.
Based on these findings, phase 3 trials are planned.
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Ibach M, et al. Phentolamine alone and in combination with low dose pilocarpine improves near vision in presbyopic subjects in the VEGA-1 phase 2 trial. Presented at: Academy; Oct. 26-29; San Diego.
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