A new FDA-approved eyedrop offers patients a nonsurgical option for eyelid lifts.
In 2020, blepharoplasty ranked as the second highest reported cosmetic surgical procedure in the United States, according to the American Society of Plastic Surgeons (ASPS).1 With 325,112 patients reporting undergoing the procedure, even more are wanting the surgical results, without the downtime.
That’s where oxymetazoline hydrochloride ophthalmic solution 0.1% (Upneeq; RVL Pharmaceuticals) comes in. The FDA approved daily prescription eyedrop for adults with acquired ptosis, lifts the upper eyelid without surgery.
In the clinical trials, 84% of patients saw some form of eyelid lift improvement while 74% had 50% or more improvement. By day 14, it was also found that lifting the eyelid ptosis helped field of vision, with about 87% of patients having some form of improvement and 40.8% showing at least 50% improvement.
The first phase 3 efficacy clinical trial for Upneeq was a 2:1 randomized, double-masked, placebo-controlled study comprised of 140 patients with acquired blepharoptosis split into 2 treatment groups for 42 days.
Study results showed that the eye drop met its primary efficacy end points as determined by the Leicester Peripheral Field Test (LPFT). Patients who received Upneeq once daily experienced a statistically significant improvement in visual field when compared to the placebo group.
Upneeq was well tolerated by patients when administered once daily over a 6-week period and there were no reported serious adverse events identified from treatment use. 2
The second phase 3 efficacy trial, a 6-week randomized, multicenter, double-masked, placebo-controlled study, evaluated the safety and efficacy of once-daily treatment of Upneeq compared with placebo for the treatment of acquired blepharoptosis. The primary end point was the mean change measurement from baseline in the top 4 rows of the LPFT in 2 time points: hour 6 on day 1 and hour 2 on day 14.
The secondary end point was the distance measurement between the center of the pupillary light reflex and the upper eyelid margin, or Margin to Reflex [MRD]-1. The trial met both primary and secondary end points. The mean change from baseline on the LPFT for day 1 was 6.3 Upneeq vs 2.1 placebo and on day 14 was 7.7 Upneeq vs 2.4 placebo. The trial also achieved a statistically significant improvement in MRD-1 at the following timepoints: 5 minutes, 15 minutes, 2 hours, and 6 hours after dose on day 1 and 14.
A trial (NCT04831047) to examine Upneeq’s effect on eyelid position, eye redness, or patient-perceived appearance of the eyes, is upcoming.
1. 2020 national plastic surgery statistics. Published April 27, 2021. Accessed May 25, 2021.
2. Osmotica pharmaceuticals plc receives fda approval for upneeqTM (Oxymetazoline hydrochloride ophthalmic solution), 0. 1% for acquired blepharoptosis (Droopy eyelid) in adults. Osmotica Pharmaceuticals. Accessed May 25, 2021. https://ir.osmotica.com/news-releases/news-release-details/osmotica-pharmaceuticals-plc-receives-fda-approval-upneeqtm/
3. Eisenstadt-chayet J. Do your lids hang low? Zoom boom gives rise to Upneeq®- only non-surgical solution & MedTech Breakthrough award winner. Published May 25, 2021. Accessed May 25, 2021.