The FDA approved Osmotica Pharmaceuticals’ (NASDAQ:OSMT) Upneeq for the treatment of acquired blepharoptosis, an abnormal drooping of the upper eyelid that can limit field of vision.
Acquired blepharoptosis is often caused by a partial or complete dysfunction of Müller’s muscle, which works with the levator superioris to elevate the eyelid. Upneeq is a 0.1% oxymetazoline hydrochloride ophthalmic solution designed to selectively target Müller’s muscle.
The approval was based on three pivotal trials, all of which demonstrated a statistically significant improvement in visual field in patients who were administered once-daily Upneeq, compared with the placebo groups.
“With the approval of Upneeq, eye care specialists now have a safe and convenient non-surgical option to treat their patients who have ptosis,” Brian Markison, Osmotica’s CEO, said in a statement.
“Upneeq has garnered a great deal of interest from ophthalmic physicians and key opinion leaders, and we are prepared to commercialize Upneeq and engage providers through our medical education outreach,” he added.
