New Drug Application Submitted for ‘Droopy Eyelid’ Treatment

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A New Drug Application (NDA) has been submitted for RVL-1201 (Vertical Pharmaceuticals) for the treatment of acquired blepharoptosis.

Blepharoptosis occurs when there is partial or complete dysfunction of the muscles that elevate the upper eyelid. In severe cases, the current standard of care is surgery. 

RVL-1201 is an ophthalmic formulation of oxymetazoline, a direct-acting α-adrenergic receptor agonist. The NDA submission includes data from 3 clinical trials (RVL-1201-201, RVL-1201-202, RVL-1201-203) assessing the efficacy and safety of the investigational treatment in patients with acquired blepharoptosis.

The two phase 3 efficacy trials included over 300 patients who were randomized to receive RVL-1201 once-daily or placebo. The primary outcome measure was mean change from baseline in the number of points seen on the Leicester Peripheral Field Test, which measures the superior (upper) field of vision. Secondary efficacy end points included change from baseline in marginal reflex distance (MRD1), which measures the distance from the center pupillary light reflex to the central margin of the upper eyelid.

“As a potential first-in-class pharmacologic treatment, we believe RVL will provide meaningful benefits to patients around the world,” said Brian Markison, CEO of Osmotica Pharmaceuticals. “Our commercial planning and readiness activities are on track for a potential launch in the second half of 2020.”

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