TARRYTOWN, N.Y., Dec. 8, 2022 /PRNewswire/ — Visiox Pharma, LLC., a privately funded biopharmaceutical firm centered on the event and commercialization of ophthalmic medication to handle extremely prevalent ailments in want of recent therapy choices, at the moment introduced that it has acquired notification from the U.S. Meals and Drug Administration (FDA) that the company has accomplished its submitting evaluate and accepted for submitting the New Drug Utility (NDA) for PDP-716 (0.35% brimonidine tartrate) for the therapy of glaucoma.
The FDA has assigned a Prescription Drug Person Charge Act (PDUFA) goal motion date of August 4, 2023.
“The NDA acceptance for submitting is an thrilling milestone and an necessary subsequent step in the direction of the deliberate approval and business launch of PDP-716,” stated Ryan Bleeks, Chief Govt Officer. “If accredited, Visiox has the potential to deliver the primary once-daily brimonidine to marketplace for the therapy of glaucoma to sufferers and eye care professionals.”
Visiox is a privately funded biopharmaceutical firm centered on the event and commercialization of ophthalmic therapeutic candidates to handle extremely prevalent ailments in want of recent therapy choices. Every day is a chance for us to disrupt and revolutionize the present market to maximise affected person and doctor satisfaction. As an agile enterprise associate, we’ll obtain this via a excessive stage of collaboration with all eye care professionals.
Visiox plans to quickly submit a second New Drug Utility for SDN-037 to the U.S. FDA to handle an unmet want for cataract surgical procedure. SDN-037 is a twice each day topical difluprednate corticosteroid using patented TJMTM (Tight Junction Modulation) proprietary formulation. The novel know-how supplies highly effective post-surgical management of irritation in a transparent answer enabling handy dosing with a confirmed lively ingredient. Cataract extraction is probably the most regularly carried out eye surgical procedure within the U.S. It accounts for 70% of all ocular surgical procedures. 50 million individuals are projected to have cataracts within the U.S. by 20501.
PDP-716, SDN-037, and TearActTM supply know-how have been licensed by Visiox from Solar Pharma Superior Analysis Firm Ltd. For extra info, please go to Visiox Pharma or LinkedIn.
1. Ocular Surgical procedure Procedures: Market Scope, 2019
Ryan S. Bleeks
Chief Govt Officer
SOURCE Visiox Pharma LLC