FDA approves novel therapy for blepharoptosis
Upneeq 0.1%, a novel treatment for acquired blepharoptosis, has been approved by the FDA, according to a press release.
Upneeq (oxymetazoline hydrochloride ophthalmic solution, Osmotica Pharmaceuticals) is a once-daily first-in-class alpha-adrenergic agonist, which is thought to target Müller's muscle to elevate the upper eyelid.
In two pivotal phase 3 efficacy studies, Upneeq demonstrated statistically significant improvements over the control in superior visual field and eyelid lift, with a separate safety study showing the drug was well-tolerated when administered every morning in both eyes for 12 weeks.
During clinical trials, the drug was known as RVL-1201.
Adverse reactions, occurring in 1% to 5% of Upneeq-treated subjects, were mostly mild and self-limited, and included punctate keratitis, conjunctival hyperemia, dry eye, blurred vision, instillation site pain, eye irritation and headache.
“Given the previous absence of any approved medical treatment options, ptosis has been often under-diagnosed or overlooked,” Tina deVries, PhD, executive vice president, research and development, Osmotica Pharmaceuticals, said. “Upneeq has the potential to address a significant unmet need in ptosis therapy.”
The company intends to make Upneeq commercially available to a select group of ophthalmologists and optometrists in August.