Ocuvex Therapeutics resubmits Complete Response Letter to USFDA for PDP-716

Ruchika Sharma

Ocuvex Therapeutics resubmits Complete Response Letter to USFDA for PDP-716

Written By : Ruchika Sharma Published On 2025-11-20T16:14:48+05:30 | Updated On 20 Nov 2025 4:14 PM IST

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

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

The PDP-716 Complete Response resubmission addresses the FDA CRL issued in July 2023, stating 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. SPARC will provide an update after the FDA has determined that the response resubmission is complete.

Read also: SPARC enters pact with University of California, San Francisco, Tiller Therapeutics for Pre-clinical Oncology asset

SPARC is a clinical stage bio-pharmaceutical company.

Sun Pharma Advanced Research CompanyUSFDAOcuvex TherapeuticsPDP 716

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751