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

FOR IMMEDIATE RELEASE SPARC announces Complete Response Letter Resubmission for PDP-716 NDA by Ocuvex Mumbai, India, November 20, 2025 – Sun Pharma Adva nced Research Company Ltd. (Reuters: SPRC.BO, Bloomberg: SPADV IN, NSE: SPARC, BSE: 532872, “SPARC”) today announced Complete Response Letter (CRL) resubmission to the US Food and Drug Administration (FDA) by Ocuvex Therapeutics Inc. ( Ocuvex) for the PDP-716 New Drug Application (NDA). 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. About PDP-716: PDP-716 is a novel, once daily, ophthalmic suspension of brimonidine tartrate 0.35%. PDP -716 was developed using SPARC’s proprietary TearActTM technology. About Sun Pharma Advanced Research Company Ltd. (CIN - L73100GJ2006PLC047837): Sun Pharma Advanced Research Company Ltd. (SPARC) is a clinical stage bio -pharmaceutical company focused on continuously improving standards of care for patients globally, through innovation in therapeutics and delivery. SPARC aims to advance availability of treatment options for patients across the world. More information about the company can be found at www.sparc.life Disclaimer: Statements in this “Document” describing the Company’s objectiv es, projections, estimates, expectations, plans or predictions or industry conditions or events may be “forward looking statements” within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ m aterially from those expressed or implied. The Company undertakes no obligation to update or revise forward looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. Contact Jaydeep Issrani Tel +91 22 66455645, Ext: 5787 Tel Direct +91 22 6645 5787 Mobile +91-9820216916 E-mail [email protected]

The release as fetched from its publisher. sparc.life ↗