SPARC resubmits PDP-716 NDA after addressing FDA concerns

Sun Pharma Advanced Research Company Ltd. (SPARC) announced the resubmission of the Complete Response Letter (CRL) for the PDP-716 New Drug Application (NDA) to the US Food and Drug Administration (FDA) by Ocuvex Therapeutics Inc. The resubmission, dated November 20, 2025, addresses issues raised in a CRL issued in July 2023.

The previous CRL cited unresolved facility inspection-related conditions at a third-party Active Pharmaceutical Ingredient (API) manufacturing facility. The FDA did not raise any concerns regarding the efficacy or safety of PDP-716. SPARC expects to provide a further update once the FDA confirms the completeness of the resubmission.

PDP-716 is a novel, once-daily ophthalmic suspension of brimonidine tartrate 0.35%, developed using SPARC's proprietary TearAct™ technology. SPARC, a clinical-stage biopharmaceutical company, focuses on advancing global patient care through therapeutic and delivery innovations.