Nyxol meets endpoint in phase 3 night vision disturbance trial
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Nyxol demonstrated positive topline results in subjects with night vision disturbances in the phase 3 LYNX-1 pivotal clinical trial, Ocuphire Pharma announced in a press release.
One hundred forty-five subjects who experienced night vision impairment were randomly assigned to receive either Nyxol (0.75% phentolamine ophthalmic solution) or placebo daily for 14 days. The primary endpoint was the gain of 15 letters or more of distance vision improvement on a low contrast chart in dim light, the release said.
Nyxol met the primary endpoint, with a greater percentage of subjects who received the eye drop gaining 15 or more letters of mesopic low contrast distance visual acuity at day 8 compared with placebo (13% vs. 3%; P < .05).
For key secondary efficacy endpoints, at day 15, 21% of subjects in the Nyxol group gained 15 or more letters compared with 3% in the placebo group (P < .01), and the percentage of subjects who gained at least 10 letters of mesopic low contrast distance visual acuity at day 8 and day 15 was higher in the Nyxol group compared with the placebo group (both P < .05).
A good safety profile and no serious adverse events were observed.
“In alignment with our overall clinical priorities, and while we plan for a future LYNX trial as needed next year, we will focus on the pivotal trials for presbyopia and on the [new drug application] submission and precommercial activities for Nyxol in reversal of mydriasis (RM),” Mina Sooch, MBA, Ocuphire founder and CEO, said in the release. “Importantly, the LYNX-1 trial results provide additional support for the safety and vision improvement benefits of Nyxol in RM and presbyopia in dim light conditions.”
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