Novel dry eye treatment shows efficacy in phase 2 trial
Click Here to Manage Email Alerts
ST-100, a novel dry eye treatment, achieved positive topline results in a phase 2 clinical trial, according to a press release from Stuart Therapeutics.
In the multicenter, randomized, controlled, double-masked trial, 160 patients received twice-daily dosing of 20 mg/mL of ST-100, 50 mg/mL of ST-100 or placebo.
The 50 mg/mL group achieved the study’s primary endpoint of Schirmer’s test responder rate at 28 days (P = .0266). The therapy also demonstrated improvement in several symptoms and ocular staining scores as early as day 7, as well as improvement in overall ocular discomfort at day 14 (P = .0332).
The treatment was well tolerated, and no serious drug-related adverse events were observed during the trial.
“The phase 2 trial has provided us with an important understanding of the efficacy and tolerability of ST-100 as a topical ophthalmic therapeutic and provided us with a wealth of human data to further explore the details of the mechanism of action and the potential for ST-100 and our collagen mimetic platform technology, PolyCol, in additional disease indications,” Eric Schlump, president and CEO of Stuart, said in the release.