Press Release

July 01, 2021
1 min read

Nyxol, pilocarpine combination meets primary endpoint in phase 2 trial for presbyopia


Press Release

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Nyxol in combination with low-dose pilocarpine successfully met primary and key secondary endpoints in a phase 2 trial evaluating its safety and efficacy for presbyopia, according to a press release from Ocuphire Pharma.

The randomized, double-masked, placebo-controlled VEGA-1 trial was a four-armed study investigating improvement in photopic binocular near vision after treatment with Nyxol (0.75% phentolamine ophthalmic solution) combined with low-dose pilocarpine.

The study enrolled 150 patients across 17 centers in the United States.

Sixty-one percent of subjects in the Nyxol and low-dose pilocarpine arm improved by at least 15 letters in photopic binocular near vision, the primary end point, at 1 hour, compared with 28% of patients receiving placebo (P = .003).

The combination therapy also met additional efficacy endpoints of three-line gain in near vision with less than five letters of distance vision loss, rapid onset and efficacy, durable near-distance improvement for at least 6 hours, sustained reduction in pupil diameter for 18 hours, binocular and monocular near distance vision improvements and efficacy in patients with both light and dark irises, the release said.

There were no serious adverse events related to the treatment, and all documented adverse events were mild, including transient conjunctival hyperemia. There were no headaches, brow aches or blurry vision, the release said.

“The results from this phase 2 VEGA-1 trial validate Nyxol’s mechanism of action on iris dilator muscle and the beneficial effects of smaller pupil size in treating presbyopia,” Jay S. Pepose, MD, PhD, Ocuphire medical advisory and corporate board member, said in the release. “These latest data support a clinical profile for Nyxol plus LDP combination that includes rapid onset of action and sustained duration of effect, while maintaining distance visual acuity in day and night conditions.”

Ocuphire plans to move the combination to phase 3 trials, the release said.