Visiox Pharma, LLC has obtained notification from the U.S. Meals and Drug Administration (FDA) that the company has accomplished its submitting overview and accepted for submitting the New Drug Software (NDA) for PDP-716 (0.35% brimonidine tartrate) for the remedy 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 vital subsequent step in the direction of the deliberate approval and industrial launch of PDP-716,” stated Ryan Bleeks, chief government officer. 

“If authorized, Visiox has the potential to carry the primary once-daily brimonidine to marketplace for the remedy of glaucoma to sufferers and eye care professionals.”

About Visiox Pharma

Visiox Pharma is a privately funded biopharmaceutical firm centered on the event and commercialization of ophthalmic therapeutic candidates to handle extremely prevalent illnesses in want of latest remedy choices. 

Visiox Pharma plans to quickly submit a second New Drug Application 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 TJM (Tight Junction Modulation) proprietary formulation. 

The novel expertise offers highly effective post-surgical management of irritation in a transparent answer enabling handy dosing with a confirmed energetic ingredient. Cataract extraction is probably the most steadily carried out eye surgical procedure within the U.S. It accounts for 70% of all ocular surgical procedures. 

PDP-716, SDN-037, and TearAct supply expertise had been licensed by Visiox from Solar Pharma Superior Analysis Firm Ltd.

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