Ocuphire initiates phase 3 study of Nyxol for night vision disturbances
Patient recruitment and screening are underway in the LYNX-1 phase 3 registration study to investigate the safety and efficacy of Nyxol for night vision disturbances, Ocuphire Pharma announced in a press release.
One hundred sixty patients with night vision disturbances are expected to be enrolled in the randomized, double-masked, placebo-controlled trial, the release said. Participants will self-administer either Nyxol, a preservative-free eye drop formulation of phentolamine mesylate, or placebo in each eye daily for 14 days.
“Nyxol is currently the only product candidate we are aware of in development for [night vision disturbances] and, if approved, could become the first pharmacological daily treatment option,” Mina Sooch, MBA, Ocuphire president and CEO, said in the release.
The primary endpoint is the percentage of participants whose mesopic, low-contrast, best corrected distance visual acuity improves by at least three lines, and the secondary endpoints are pupil diameter reductions, other distance and near visual acuity measures, safety and tolerability.
Nyxol is also being developed for reversal of mydriasis and presbyopia.