Visiox Pharma has announced the submission of a New Drug Application to the FDA for lead product candidate, PDP-716.
Visiox Pharma this week announced the submission of a New Drug Application to the FDA for lead product candidate, PDP-716 (0.35% brimonidine tartrate), which has the potential to be the first once-daily brimonidine to enter the market for the treatment of glaucoma.
"This NDA submission marks a significant milestone for Visiox," said Ryan Bleeks, Chief Executive Officer. "We believe the patented TearAct delivery technology, which provides slow, consistent, and sustained release for IOP control throughout the day will address a significant unmet need for glaucoma patients."
The NDA submission is supported by data demonstrating IOP reduction for ocular hypertension and open angle glaucoma while maintaining an excellent safety profile.
Visiox 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. Each day is an opportunity for us to disrupt and revolutionize the current market to maximize patient and physician satisfaction. As an agile business partner, we will achieve this through a high level of collaboration with all eye care professionals.
Visiox plans to submit a second New Drug Application for SDN-037 to the U.S. FDA later this year 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.