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Ocuphire Pharma provides anticipated 2023 milestones
The Fly

Ocuphire Pharma provides anticipated 2023 milestones

Ocuphire Pharma announced that the Company will release its first quarter 2023 financial results on Monday, May 15, 2023. The Company also provided a corporate update, reiterating its previous guidance on its clinical programs. "All development program timelines remain unchanged from previous guidance and the Ocuphire team is committed to executing on our near-term priorities. 2023 is a pivotal year for Ocuphire with multiple potential late-stage clinical, regulatory, and product approval catalysts across the Nyxol and APX3330 programs," said Rick Rodgers, Interim CEO and President of Ocuphire. In February 2023, Ocuphire announced that U.S. Food and Drug Administration had accepted for review a New Drug Application for Nyxol in RM and set a PDUFA date of September 28, 2023. The NDA was submitted in November 2022 and was supported by positive results from the four MIRA clinical trials that collectively involved over 600 subjects, including pediatric subjects over 3 years old. An NDA approval for Nyxol in RM would trigger a $10 million payment from Viatris. The Company entered into a partnership with Viatris in November 2022 and Viatris has highlighted the Nyxol portfolio of indications as one of the key elements of its plan to create a global eye care leader. The partnership provides an externally financed pathway to complete development and all regulatory activities for Nyxol and provides a commercial partner to execute successful US and global launches. The financial elements of the agreement have strengthened Ocuphire’s balance sheet and provides additional capital to help advance APX3330 . Topline results from the ZETA-1 Phase 2 trial of oral APX3330 for the treatment of diabetic retinopathy were announced in January 2023. Oral APX3330 achieved statistical significance on a key pre-specified secondary endpoint of binocular greater than or equal to 3-step worsening of DRSS and demonstrated favorable safety and tolerability after 24 weeks of treatment. This binocular secondary endpoint is a potential Phase 3 registration endpoint. The Company plans an End-of-Phase 2 FDA meeting in the second half of 2023 to formally agree on this endpoint. In January 2023, the Company announced the initiation of the VEGA-2 Phase 3 pivotal trial in presbyopia, with the first patient enrolled in late December. VEGA-2 is evaluating treatment efficacy and safety for two labels for presbyopia: Nyxol alone and Nyxol with adjunctive Low Dose Pilocarpine therapy. The Company plans to release topline data from VEGA-2 in the second half of 2023 and to initiate a second Phase 3 pivotal trial in presbyopia, and a one-year safety study in 2023.

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