Ocuphire shares up, as NDA for Nyxol accepted by FDA

Shares of US ophthalmic drug developer Ocuphire Pharma (Nasdaq: OCUP) were lifted 7.6% to $3.53 this morning, as the company updated on the development of its lead product candidate.

The US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Nyxol (phentolamine ophthalmic solution 0.75%) for the treatment of pharmacologically-induced mydriasis (RM), Ocuphire revealed. The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of September 28, 2023.

“The FDA’s acceptance of the NDA submission and PDUFA date in late September for Nyxol sets the stage for an exciting 2023”, said Mina Sooch, founder and chief executive of Ocuphire, adding: “We look forward to working closely with the FDA during the review process. If approved later this year, Nyxol eye drops will be the first prescription reversal drop available for patients in the US. 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.”