• The approval is based on P-III trial assessing Upneeq vs PBO in 2:1 ratio in 140 patients with acquired blepharoptosis split into two treatment groups for 42 days. Additionally- another second P-III clinical trial evaluated safety and efficacy of Upneeq vs PBO in 35 patients to treat acquired blepharoptosis
• The study resulted in well tolerated results when administered once daily over a six-week period with no serious AEs and met its both 1EPs and 2EPs- mean change from baseline on the LPFT on Hour 6- Day 1 6.3 vs 2.1- Hour 2 Day 14 7.7 vs 2.4- improvement in MRD-1 at 5 and 15 minutes- and 2 and 6 hours post dose on days 1 and 14
• Upneeq (oxymetazoline hydrochloride ophthalmic solution) is a QD ophthalmic formulation of oxymetazoline and an alpha-adrenergic receptor agonist a novel pharmacologic treatment indicated for the treatment of acquired blepharoptosis

­ Ref: Osmotica | Image: Osmotica