■ If its recent NDA submission leads to FDA approval, Visiox Pharma’s PDP-716 (0.35% brimonidine tartrate), could be the market’s first once-daily brimonidine for glaucoma. The company said that the NDA submission is supported by data that showed IOP reduction for ocular hypertension and open-angle glaucoma while maintaining an excellent safety profile.
“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,” said CEO Ryan Bleeks in a news release.
Visiox plans to submit a second NDA for its twice-daily topical difluprednate corticosteroid utilizing its patented TJM (Tight Junction Modulation) formulation. “The novel technology provides powerful post-surgical control of inflammation in a clear solution enabling convenient dosing with a proven active ingredient,” according to the news release.