Ocuphire Reports Results of Nyxol in P-III (MIRA-3) Registration Trial for the Reversal of Pharmacologically-Induced Mydriasis
Shots:
- The P-III (MIRA-3) trial evaluates Nyxol vs PBO in a ratio (2:1) in 368 patients with RM for 1hr. after receiving one of 3 mydriatic agents
- The trial met its 1EPs & 2EPs i.e., 58% vs 6% of patients returned to baseline PD at 90min., early onset of action with 42% vs 2% of patients at baseline PD @60min. post-dose, similar efficacy was observed with one or two drops of Nyxol, 36% of PBO treated patients returned to baseline PD @6hr.
- The therapy restored normal distance corrected near vision faster than PBO, favorable safety & tolerability profile with no serious AEs or withdrawals due to AEs. The company plans to file an NDA with the US FDA in late 2022 & Nyxol is expected to launch in H2’23 for RM
Ref: Globe Newswire | Image: Ocuphire
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