SPARC Announces Complete Response Letter Resubmission for PDP-716 NDA by Ocuvex

Sun Pharma Advanced Research Company Ltd. (SPARC) announced that Ocuvex Therapeutics Inc. (Ocuvex) has resubmitted a Complete Response Letter (CRL) to the US Food and Drug Administration (FDA) for the PDP-716 New Drug Application (NDA). The resubmission addresses the FDA's CRL issued in July 2023, which stated unresolved facility inspection-related conditions at a third-party Active Pharmaceutical Ingredient (API) manufacturing facility. The FDA did not raise any concerns related to the efficacy or safety of PDP-716. PDP-716 is a novel, once daily, ophthalmic suspension of brimonidine tartrate 0.35%, developed using SPARC’s proprietary TearAct™ technology. SPARC will provide an update after the FDA has determined that the response resubmission is complete.