The Food and Drug Administration (FDA) has approved Upneeq™ (oxymetazoline hydrochloride ophthalmic solution; Osmotica) for the treatment of acquired blepharoptosis in adults.
Upneeq 0.1% is a novel, once-daily, direct-acting alpha adrenergic receptor agonist that is believed to selectively target Müller muscle and elevate the upper eyelid. The product contains 1mg of oxymetazoline hydrochloride per mL, which is equivalent to 0.09 mg (0.09%) of oxymetazoline free base.
The approval was based on data from 2 double-masked, vehicle-controlled, parallel-group phase 3 trials (Trial 1 and Trial 2) that evaluated the efficacy and safety of Upneeq in 304 patients with acquired blepharoptosis. Patients were randomized 2:1 to receive Upneeq once daily or vehicle for 42 days. The primary end point was the mean change from baseline in the number of points seen on the Leicester Peripheral Field Test in the study eye at hour 6 on day 1 and hour 2 on day 14. A secondary end point included the change from baseline in marginal reflex distance 1 (MRD1).
In both studies, improvement in superior visual field was observed with Upneeq at the 2-hour time point and maintained at the 6-hour time point. Results from Trial 1 (N=140) showed that Upneeq met the primary end point achieving a statistically significant improvement at hour 6 on day 1 (mean difference 3.7; 95% CI, 1.8-5.6; P <.01) and at hour 2 on day 14 (mean difference 4.2; 95% CI, 2.0-6.0; P <.01) vs vehicle.
Additionally, statistically significant improvements in the Upneeq treatment arm were noted in Trial 2 (N=164) at hour 6 on day 1 (mean difference 4.2; 95% CI, 2.4-6.1; P <.01) and at hour 2 on day 14 (mean difference 5.3; 95% CI, 3.7-7.1; P <.01) vs vehicle. Both studies demonstrated greater MRD1 increases at both time points vs vehicle.
With regard to safety, the most common adverse reactions observed were punctate keratitis, conjunctival hyperemia, dry eye, vision blurred, instillation site pain, eye irritation and headache. Upneeq should be used with caution in patients with severe or unstable cardiovascular disease, orthostatic hypotension, uncontrolled hypertension or hypotension, cerebral or coronary insufficiency, or Sjogren syndrome.
“With the approval of Upneeq, eye care specialists now have a safe and convenient non-surgical option to treat their patients who have ptosis,” said Brian Markison, Osmotica’s CEO. “We look forward to launching Upneeq through our subsidiary, RVL Pharmaceuticals, Inc, and ensuring its widespread availability through the Company’s pharmacy.”
The Company expects to have Upneeq available next month to a selected group of ophthalmologists and optometrists through an early experience program. The product will be supplied as a 0.3mL single patient-use container in 15- and 30-count cartons.
For more information visit osmotica.com.