Perspective from Jason Bacharach, MD
Disclosures: Slonim reports he received personal fees from RevitaLid and is a paid consultant to RVL Pharmaceuticals. Please see the study for all other authors’ relevant financial disclosures.
October 28, 2020
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Oxymetazoline hydrochloride 0.1% well tolerated for ptosis treatment

Perspective from Jason Bacharach, MD
Disclosures: Slonim reports he received personal fees from RevitaLid and is a paid consultant to RVL Pharmaceuticals. Please see the study for all other authors’ relevant financial disclosures.
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Oxymetazoline hydrochloride 0.1%, a preservative-free eye drop, was well tolerated and produced positive outcomes in the treatment of acquired ptosis, according to a study.

“Blepharoptosis (or ptosis) is an abnormal drooping of the upper eyelid margin with the eye in primary gaze,” Charles B. Slonim, MD, of the department of ophthalmology, University of South Florida Morsani College of Medicine, and colleagues wrote. “Standard of care is surgery, often targeting the upper eyelid retractor muscles. While effective in improving visual function and quality-of-life measures, there are risks associated with surgical intervention.”

The pooled analysis looked at data from two randomized, double-masked, placebo-controlled phase 3 clinical trials to examine the safety and efficacy of Upneeq (oxymetazoline 0.1%, Osmotica Pharmaceuticals) for the treatment of acquired ptosis. The studies enrolled a total of 304 participants randomly assigned 2:1 to treatment with oxymetazoline (66.8% of participants) or vehicle (33.2% of participants). Participants self-administered a single drop per eye once daily for 42 days. Superior visual field deficits and marginal reflex distance 1 were assessed at baseline, day 1 (6 hours after instillation) and day 14 (2 hours after instillation).

Oxymetazoline was associated with an increase in the mean number of points seen on the Leicester Peripheral Field Test vs. vehicle on day 1, 5.9 vs. 1.8 (P < .001), and on day 14, 7.1 vs. 2.4 (P < .001). As well, mean difference in increase in marginal reflex distance 1 was 0.47 mm and 0.67 mm (both P < .001) in favor of the study drug at day 1 and day 14, respectively.

Regarding safety, treatment-emergent adverse events were similar between the treatment group (31%) and the control group (35.6%), with most considered to be mild.