Sun Pharma Advanced Research Company (SPARC) announced that Ocuvex Therapeutics has resubmitted a Complete Response Letter (CRL) to the US Food and Drug Administration (FDA) for the New Drug Application (NDA) of PDP-716.

The resubmission addresses the FDA CRL issued in July 2023, which cited unresolved facility inspection-related conditions at a third-party Active Pharmaceutical Ingredient (API) manufacturing facility. Notably, the agency did not raise any concerns related to the efficacy or safety of PDP-716.    

SPARC said it will provide an update one the FDA has determined that the resubmission is complete.  

PDP-716 is a novel, once-daily ophthalmic suspension of brimonidine tartrate 0.35 percent, developed using SPARC’s proprietary TearAct technology.