Visiox Pharma, LLC has received notification from the U.S. Food and Drug Administration (FDA) that the agency has completed its filing review and accepted for filing the New Drug Application (NDA) for PDP-716 (0.35% brimonidine tartrate) for the treatment of glaucoma.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 4, 2023.
“The NDA acceptance for filing is an exciting milestone and an important next step towards the planned approval and commercial launch of PDP-716,” said Ryan Bleeks, chief executive officer.
“If approved, Visiox has the potential to bring the first once-daily brimonidine to market for the treatment of glaucoma to patients and eye care professionals.”
About Visiox Pharma
Visiox Pharma is a privately funded biopharmaceutical company focused on the development and commercialization of ophthalmic therapeutic candidates to address highly prevalent diseases in need of new treatment options.
Visiox Pharma plans to soon submit a second New Drug Application for SDN-037 to the U.S. FDA to address an unmet need for cataract surgery. SDN-037 is a twice daily topical difluprednate corticosteroid utilizing patented TJM (Tight Junction Modulation) proprietary formulation.
The novel technology provides powerful post-surgical control of inflammation in a clear solution enabling convenient dosing with a proven active ingredient. Cataract extraction is the most frequently performed eye surgery in the U.S. It accounts for 70% of all ocular surgeries.
PDP-716, SDN-037, and TearAct delivery technology were licensed by Visiox from Sun Pharma Advanced Research Company Ltd.