Oxymetazoline 0.1% solution receives US FDA nod for treatment of ptosisJuly 10, 2020 0 By FM
The biopharmaceutical company Osmotica Pharmaceuticals plc, announced that the company received the US FDA approval for oxymetazoline hydrochloride ophthalmic solution 0.1% (Upneeq) for treatment against acquired blepharoptosis or ptosis in adults.
Ptosis is a condition characterised by the abnormal drooping of the upper eyelid that can limit the field of vision. Acquired ptosis often results from a partial or complete dysfunction of Müller’s muscle, which in conjunction with the levator superioris, elevates the eyelid.
The solution demonstrated statistically significant improvements compared to placebo in both superior visual field, as measured by the Leicester Peripheral Field Test (LPFT), and eyelid lift, as measured by the Marginal Reflex Distance Test (MRD-1) in two pivotal double-masked efficacy studies.
The third pivotal safety study showed enhanced tolerance when administered once daily in the morning (to both eyes) over a 12-week period.
“With the approval of Upneeq, eye care specialists now have a safe and convenient non-surgical option to treat their patients who have ptosis,” stated Brian Markison, Chief Executive Officer.
Results from Upneeq’s phase III efficacy clinical trial showed that the formulation met its primary efficacy endpoints, which were a change in baseline visual field as measured by the LPFT and improvement in the measurement of the distance between the center of the pupillary light reflex and the upper eyelid margin.
Adverse reactions that occurred in 1-5% of subjects treated with Upneeq were punctate keratitis, conjunctival hyperemia, dry eye, blurred vision, instillation site pain, eye irritation and headache.