Source: BioSpace
Area: News
According to a Biospace report, positive phase III data have been reported for Omeros' experimental ocular drug, OMS302. The drug is a combination of the anti-inflammatory agent ketorolac and the mydriatic agent phenylephrine and is intended for the maintenance of mydrioasis (pupil dilation) and reduction of post-operative pain during cataract and other lens replacement surgery.
The multicenter, double-blind, phase III clinical trial randomised 405 patients to either OMS302 or placebo. The primary endpoint, maintenance of intraoperative mydriasis, which is critical to the safety and surgical ease of lens replacement surgery, was met (p<0.00001).
OMS302 also demonstrated statistical superiority (p<0.00001) over placebo in reduction of pain in the early postoperative period.
The most common adverse events were eye pain, eye inflammation, headache and increased intraocular pressure with frequency being similar between the two groups.
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