Visiox Pharma Announces FDA Acceptance of NDA for Glaucoma Drug Candidate

Visiox Pharma announced that it has received notification from the 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," Ryan Bleeks, Chief Executive Officer, said in a company news release. "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."

Visiox plans to soon submit a second new drug application for SDN-037 to the FDA to address an unmet need for cataract surgery. SDN-037 is a twice daily topical difluprednate corticosteroid utilizing patented TJMTM (Tight Junction Modulation) proprietary formulation. The novel technology is mdesigned to provide powerful post-surgical control of inflammation in a clear solution enabling convenient dosing with a proven active ingredient.

PDP-716, SDN-037, and TearAct delivery technology were licensed by Visiox from Sun Pharma Advanced Research Company Ltd.