FDA approves Upneeq to treat blepharoptosis. - Osmotica Pharma

Osmotica Pharmaceuticals plc, a fully integrated biopharmaceutical company, announced that the FDA has approved Upneeq (oxymetazoline hydrochloride ophthalmic solution), 0.1%, formerly known as RVL-1201, its novel treatment for acquired blepharoptosis, or ptosis, a condition characterized by the abnormal drooping of the upper eyelid that can limit field of vision. Upneeq becomes the only FDA-approved medical treatment for ptosis. Upneeq is a safe and effective, first-in-class treatment for acquired ptosis, which often results from a partial or complete dysfunction of Müller’s muscle, which in conjunction with the Levator superioris, elevates the eyelid. Upneeq demonstrated statistically significant improvements compared to placebo in both superior visual field, as measured by the Leicester Peripheral Field Test (LPFT), and eyelid lift, as measured by the Marginal Reflex Distance Test (MRD-1) in two pivotal double-masked efficacy studies. A third pivotal safety study successfully showed that Upneeq was well tolerated when administered once daily in the morning (to both eyes) over a 12-week period. The majority of adverse events were mild and self-limited.