Ocuphire Pharma announced it has submitted a new drug application (NDA) to the FDA for phentolamine ophthalmic solution 0.75% (Nyxol) for the reversal of pharmacologically-induced mydriasis (RM).
Wasn’t Nyxyol just in the news?
It was! Ocuphire hinted at this submission last month when announcing a global license agreement with FamyGen Life Sciences for the exclusive rights to develop and commercialize Nyxol.
Remind me about Nyxol.
Nyxol is a preservative-free eye drop designed to be administered once a day to reduce pupil dilation in patients with three indications: dim light vision disturbances, presbyopia, and reversal of mydriasis. It was granted a small business waiver of the Prescription Drug User Fee Act (PDUFA) by the FDA for the NDA in September 2022. (via)
How did it perform in clinical trials?
Nyxol has been assessed in 12 completed clinical trials. It showed a favorable safety and tolerability profile for RM across all studies, including the MIRA-1 (NCT04024891), MIRA-2 (NCT04620213) and MIRA-3 (NCT05134974) registration trials, as well as the MIRA-4 phase 3 pediatric safety trial (NCT05223478).
More details, please.
The MIRA-2 and MIRA-3 trials both met their primary and secondary endpoints, with Nyxol exhibiting a statistically significant superiority in comparison to a placebo: dilated eyes returned to baseline pupil diameter as early as 60 to 90 minutes. The MIRA-4 trial’s positive data signals potential for Nyxol in RM to treat pediatric patients ages 3 and older.
What’s next?
The FDA has 60 days to determine whether to accept Ocuphire’s NDA. If accepted, it has 6 to 10 months to review Nyxol for official approval. If approved, Nyxol would become the only commercially available treatment option indicated for the reversal of dilated eyes.