FDA accepts NDA for Nyxol drops for mydriasis reversal
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The FDA accepted a new drug application for Nyxol for the reversal of pharmacologically induced mydriasis, according to a press release from Ocuphire Pharma.
The Prescription Drug User Fee Act date for the eye drop is Sept. 28.
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The filing is supported by results from the MIRA clinical program. In the MIRA-2 and MIRA-3 trials, Nyxol (phentolamine ophthalmic solution 0.75%) helped dilated pupils return to their baseline diameter as early as 60 minutes and 90 minutes, according to the release. In addition, the drop demonstrated favorable safety and tolerability across all trials.
“If approved later this year, Nyxol eye drops will be the first prescription reversal drop available for patients in the U.S.,” Mina Sooch, MBA, founder and CEO of Ocuphire, said in the release. “In addition, we look forward to leveraging the synergies of this first NDA for Nyxol in potential supplementary NDAs for presbyopia and dim light vision disturbances indications in the future.”
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