Drugs

Ocuvex Resubmits NDA for Glaucoma Drug

Sun Pharma Advanced Research Company (SPARC) says that Ocuvex Therapeutics has resubmitted an NDA for PDP-716, more than two years after FDA the agency issued a complete response letter (CRL) tied to manufacturing deficiencies at a third-party supplier. The agency 7/2023-issued CRL cited inspection-related issues at an external active pharmaceutical ingredient (API) manufacturing site.

In both a 2023 notice about the CRL and the latest update, SPARC emphasized that the agency has raised no concerns about the efficacy or safety of PDP-716, a once-daily ophthalmic suspension of brimonidine tartrate 0.35% for treating glaucoma, and developed with SPARC’s TearAct technology. No additional clinical trials have been requested, it adds.

PDP-716 had previously been licensed to Visiox Pharmaceuticals for commercialization outside India and China. Ocuvex is now leading the resubmission effort, according to SPARC.

Ocuvex Resubmits NDA for Glaucoma Drug

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