Oxymetazoline hydrochloride 0.1% well tolerated for ptosis treatment
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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.
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From a safety and efficacy standpoint in clinical trials, the drug did very well.
The phase 3 trials, for which I was an investigator, showed positive outcomes after we instilled Upneeq on day 1 and day 14. It met both primary and secondary efficacy endpoints of improvement in points seen with automated visual field testing as well as elevated upper lid position measured by marginal reflex distance. What was interesting is the drops worked quickly. We were noticing improvement in the upper lid position within 5 to 10 minutes after instillation that was significantly different from baseline. Both from a functional standpoint and a cosmetic standpoint, it was great to see that the effects persisted when measured 6 hours after a single morning dose. Some patients were noted to benefit anecdotally even longer than the 6-hour time point where formal measurements were obtained.
Regarding safety, the drug fared very well. Treatment-related adverse events were about the same in both the treatment arm and the control arm, with most being mild in intensity. It was very well tolerated with low dropout rates, and adverse events included mild irritation or redness with application, commonly seen with drop trials.
Surgery for upper lid ptosis is no walk in the park. There are lots of risk associated even for excellent surgeons, and there might be a subgroup of patients in which the risks outweigh the potential benefits. One of the benefits of this drug is that it does not preclude the surgical treatment option at a later date. Patients can use this drop as needed and may choose to use it, for example, on a special occasion or, if desired, every day.
Overall, it is a great opportunity for doctors who have not been treating ptosis and only referring patients for surgery as well as for patients who either have been lacking a nonsurgical treatment option or have not really discussed it with their clinician.
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