![]() ![]() Topline results from the VEGA-2 Phase 3 pivotal trial of Nyxol in presbyopia are expected in late 2023.FDA approval in RM would trigger a $10 million milestone payment to Ocuphire. In February 2023, the Company announced that the FDA has accepted for review a New Drug Application (NDA) for Nyxol ® in RM and set a PDUFA date of September 28, 2023.The Company plans an End-of-Phase 2 FDA meeting in the second half of 2023 to formally confirm this endpoint and other clinical trial parameters. This binocular secondary endpoint is a potential Phase 3 registration endpoint. Oral APX3330 achieved statistical significance on a key pre-specified secondary endpoint of binocular ≥ 3-step worsening of DRSS and demonstrated favorable safety and tolerability. In January 2023, the Company announced topline results from the ZETA-1 Phase 2 trial of oral APX3330 for the treatment of diabetic retinopathy (DR).Nyxol: Topline results from VEGA-2 Phase 3 pivotal trial of Nyxol in Presbyopia (Late 2023).FDA approval in RM would trigger a $10 million milestone payment to Ocuphire (September 28, 2023) APX3330: End of Phase 2 meeting with FDA to confirm Phase 3 regulatory path for Oral APX3330 in DR (2H 2023).With a strong cash position and our partner Viatris funding the Nyxol program, we are well positioned to advance both APX3330 and Nyxol programs.” For Nyxol, we look forward to the September 2023 PDUFA date in its first indication in RM. If approved, APX3330 has the potential to be a non-invasive, oral, early intervention treatment for millions of DR patients at risk of progressing to vision-threatening complications. “Based on the efficacy and safety data from the ZETA-1 Phase 2 trial of APX3330, we are preparing for an End-of-Phase 2 meeting with the FDA to confirm Phase 3 registration endpoints and study parameters. ![]() “Ocuphire made significant progress across both our APX3330 and Nyxol programs throughout the first quarter,” said Rick Rodgers, Interim Chief Executive Officer. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing novel therapies for the treatment of unmet needs of patients with retinal and refractive eye disorders, today announced financial results for the first quarter ended March 31, 2023, and provided a corporate update. PDUFA date for Nyxol First Indication in Reversal of Pharmacologically-Induced Mydriasis (RM) Set for SeptemNyxol Development and Commercialization Funded by ViatrisĬash Balance of $39 Million Expected to Fund Operations into 2025įARMINGTON HILLS, Mich., (GLOBE NEWSWIRE) - Ocuphire Pharma, Inc. End-of-Phase 2 Meeting with FDA Anticipated in 2H 2023 to Confirm Phase 3 Regulatory Path for Oral APX3330 in Diabetic Retinopathy (DR) ![]()
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