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.3
In clinical trials, 84% of patients had some form of improvement and 74% had 50% or more improvement in eyelid lift. It has also been found to improve the upper field of vision, with about 87% of patients having some form of improvement and 40.8% had at least 50% improvement by day 14.
Upneeq’s first phase 3 efficacy clinical trial was a 2:1 randomized, double-masked, placebo-controlled study. The study was comprised of 140 patients with acquired blepharoptosis split into two treatment groups for 42 days.
The results demonstrated that the treatment met its primary efficacy endpoints 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. It was well tolerated by patients in this clinical trial when administered once daily over a six-week period and there were no serious adverse events identified from treatment. 2
The second phase 3 efficacy trial was a 6-week randomized, multicenter, double-masked, placebo-controlled study to evaluate the safety and efficacy of once-daily treatment of Upneeq compared with placebo for the treatment of acquired blepharoptosis. The primary endpoint was a measurement of the mean change from baseline in the top four rows of the LPFT as measured in two time points: hour 6 on day 1 and hour 2 on day 14.
The secondary endpoint was a measurement of the distance between the center of the pupillary light reflex and the upper eyelid margin, or Margin to Reflex [MRD]-1. The trial met both the primary and secondary endpoints. The mean change from baseline on the LPFT on hour 6 on day 1 was 6.3 for Upneeq vs 2.1 for the placebo and on hour 2 on day 14 was 7.7 for Upneeq vs 2.4 for 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.
There is an upcoming trial (NCT04831047) to see if Upneeq has an effect on eyelid position, eye redness, or patient-perceived appearance of the eyes.
1. 2020 NATIONAL PLASTIC SURGERY STATISTICS. Published online April 27, 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 online May 25, 2021.