Vertical Pharmaceuticals, a subsidiary of Osmotica Pharmaceuticals, announced the submission of a new drug application (NDA) to the FDA for approval of RVL-1201 (RVL) for the treatment of acquired blepharoptosis (droopy eyelid).
RVL is a novel, once-daily ophthalmic formulation of oxymetazoline, a direct-acting α-adrenergic receptor agonist, which when administered to the eye is believed to selectively target Müller’s muscle and elevate the upper eyelid. The standard of care is surgery, which is often reserved only for severe cases and may carry an increased risk of adverse events such as infection, bleeding, and asymmetry. If approved, RVL will be the first pharmacologic treatment option for the wide range of patients suffering from droopy eyelids.
The NDA submission is supported by a robust development program with compelling safety and efficacy data from three well-controlled pivotal studies—two efficacy and one extended-duration safety trial, according to Vertical Pharmaceuticals.
“We are pleased to submit our NDA to the FDA. As a potential first-in-class pharmacologic treatment, we believe RVL will provide meaningful benefits to patients around the world,” Brian Markison, Chief Executive Officer of Osmotica Pharmaceuticals, said in a company news 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.”