Vertical Pharmaceuticals, a subsidiary of Osmotica Pharmaceuticals, has submitted a new drug application to the FDA for RVL-1201, its acquired blepharoptosis treatment candidate, according to a press release.
The once-daily ophthalmic formulation of the direct-acting alpha-adrenergic receptor agonist oxymetazoline is believed to target Müller’s muscle and elevate the upper eyelid, the release said.
“As a potential first-in-class pharmacologic treatment, we believe RVL will provide meaningful benefits to patients around the world,” Brian Markison, CEO of Osmotica Pharmaceuticals, said in the release. “Our commercial planning and readiness activities are on track for a potential launch in the second half of 2020. We are excited to enter the ophthalmic therapeutic area and look forward to exploring broader global partnership opportunities to help RVL reach its true potential.”
The company plans to present phase 3 clinical trial data for RVL-1201 in October at the Ophthalmology Innovation Summit and American Society of Ophthalmic Plastic and Reconstructive Surgery fall scientific symposium.