Nyxol meets primary endpoint in trial evaluating reversal of mydriasis
Click Here to Manage Email Alerts
In a second phase 3 registration trial, Nyxol helped reverse pharmacologically induced mydriasis at 90 minutes, according to a press release from Ocuphire Pharma.
The drop, an investigational formulation of phentolamine mesylate, is designed to reduce pupil size by inhibiting contraction of the iris dilator muscle. Efficacy and safety of the drop were evaluated in the MIRA-3 trial in 368 participants who underwent pharmacologically induced mydriasis.
Among those who received Nyxol, 58% met the primary endpoint and returned to 0.2 mm or less of baseline pupil diameter at 90 minutes compared with 6% in the placebo group (P < .0001). At 60 minutes, the effect was seen in 42% of Nyxol participants and 2% of placebo participants (P < .0001). In the placebo group, only 36% of participants returned to baseline at 6 hours.
No serious adverse events were recorded. Mild transient conjunctival hyperemia occurred in 11% of participants.
The results confirm the findings of the earlier MIRA-2 phase 3 trial. So far, more than 900 participants have been studied across 10 clinical trials, with more than 550 receiving Nyxol.
“Today’s announcement means that that we have two FDA registration trials to support potential approval for the [reversal of mydriasis] indication. We intend to file an NDA with the U.S. FDA in late 2022, which, if approved, would position Ocuphire for commercial launch of Nyxol in [reversal of mydriasis] in the second half of 2023,” Mina Sooch, MBA, president and CEO of Ocuphire Pharma, said in the release.
Click Here to Manage Email Alerts