JAMA Ophthalmology Publishes Pooled Analysis of Data from two Phase 3 Clinical Trials of Upneeq (oxymetazoline hydrochloride, 0.1% solution) for Acquired Ptosis

-- Phase 3 trials showed UPNEEQ was associated with positive outcomes after instillation on days 1 and 14 and was well-tolerated, demonstrating its potential promise for the treatment of acquired ptosis --

BRIDGEWATER, N.J., Oct. 01, 2020 (GLOBE NEWSWIRE) -- RVL Pharmaceuticals, Inc., a subsidiary of Osmotica Pharmaceuticals plc (Nasdaq: OSMT) (Osmotica), today announced that JAMA Ophthalmology has published pooled analysis of data from two Phase 3 clinical trials of Upneeq (oxymetazoline hydrochloride ophthalmic solution), 0.1%, for treatment of acquired blepharoptosis (ptosis) in adults. Upneeq, a novel pharmacologic agent, is the first and only ophthalmic formulation approved by the U.S. Food and Drug Administration (FDA) for the treatment of ptosis. Upneeq is a preservative-free eye drop administered once daily to the ptotic eye(s).  

In two Phase 3 studies comprising of 304 patients, the treatment was associated with positive outcomes after instillation on days 1 and 14 and was well tolerated.  

Ptosis is an abnormal drooping of the upper eyelid margin with the eye in primary gaze¹. In addition to the characteristic asymmetric or sleepy appearance caused by ptosis, obstruction of the pupil by the upper eyelid can lead to superior visual field deficits.² Ptosis is a common eyelid disorder that is often associated with aging^{3 4 5}.

“Upneeq contains oxymetazoline, a potent, direct-acting alpha-adrenergic receptor agonist, which when administered to the eye, is believed to stimulate Müller muscle causing contraction resulting in elevation of the upper eyelid,” said Tina deVries, PhD, Executive Vice President, Research & Development, Osmotica. “These trials represent a meaningful step in our evolution to an innovation-focused specialty pharmaceutical company.”  

“Acquired blepharoptosis is a common, but often overlooked and under-treated, ophthalmic condition, leaving many patients frustrated until they become candidates for surgery,” said Charles Slonim, M.D., Chief Medical Officer, Oculos Development Services and lead medical monitor for the Phase 3 trials. “In these clinical trials, we saw statistically significant improvements in the ptosis-induced superior visual field defects and drooping upper eyelid positions. These improvements were observed from the first patient assessment on Day 1 and maintained over the 14-day treatment period. Upneeq, which was just recently approved by the FDA, has the potential to significantly change the treatment paradigm in a condition where patients and clinicians have had only surgical treatment options.”