Mydriasis trial results expected in 2012

Seattle-Data are expected early next year from a phase 3 trial evaluating a product (OMS302, Omeros) used to maintain intraoperative mydriasis and reduce postoperative pain and inflammation associated with cataract surgery and other lens replacement surgery, according to the company. The first patients in the study have been treated.

The product, a proprietary combination of an anti-inflammatory active pharmaceutical ingredient (API) and an API that causes mydriasis, is added to standard irrigation solution.

Data expected to be released in the first quarter of next year will come from the North American segment of the two-study phase 3 clinical program, already under way in patients undergoing cataract surgery and refractive lens exchange. The company expects to begin the other randomized, double-blind, placebo-controlled, multicenter trial after it completes discussions with regulators to ensure that the collected data meet European expectations for marketing approval. The co-primary endpoints for both trials, maintenance of intraoperative mydriasis and reduction of postoperative pain, are the same as those achieved in a recently completed 221-patient phase IIb trial.

“[The product] has the potential to represent a significant advance for both ophthalmologic surgeons and their patients,” said Gregory A. Demopulos, MD, chairman and chief executive officer of Omeros. “The pace of enrollment to date has exceeded our expectations, and we look forward to announcing data from this program early next year.”

Each API used in the product has a well-known safety and pharmacologic profile, according to the company. Also, according to the company, FDA-approved drugs containing each of these APIs have been used in ophthalmologic clinical practice for more than 15 years, and both APIs are contained in generic, FDA-approved drugs.

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