Ocuphire aims to advance investigational oral treatment for diabetic retinopathy
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Ocuphire Pharma announced plans to meet with the FDA in the fourth quarter of 2023 to advance a phase 3 regulatory path for APX3330, an investigational treatment for diabetic retinopathy and diabetic macular edema.
According to a company press release, Ocuphire has scheduled an end-of-phase 2 meeting with the FDA, based on the strength of efficacy and safety results from the ZETA-1 phase 2 trial of APX3330. Prevention of binocular 3-step worsening of diabetic retinopathy has been identified as the phase 3 registration endpoint, which the company will confirm with the FDA as part of APX3330’s path to approval.
“If approved, we believe that APX3330 has the potential to shift the current wait-and-watch deferred treatment paradigm for [non-proliferative diabetic retinopathy (NPDR)] without [diabetic macular edema] and be the first noninvasive, oral, early treatment for the 8 million NPDR patients who are at risk of progressing to vision threatening complications,” Rick Rodgers, Ocuphire’s interim CEO, said in the release.
The oral tablet APX3330 is a small-molecule inhibitor of reduction oxidation effector factor-1 protein, which is designed to reduce levels of vascular endothelial growth factor and inflammatory cytokines and is administered twice daily.
The company also announced additional milestones that include a Prescription Drug User Fee Act date of Sept. 28 for Nyxol, a preservative-free eye drop formulation of phentolamine mesylate for reversal of pharmacologically induced mydriasis, and topline results from the VEGA-2 phase 3 trial of Nyxol for presbyopia and dim light vision disturbances.
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