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Positive trial results for OMS 302 (Omeros Corporation) in Cataract surgery

Read time: 1 mins
Last updated:26th Apr 2013
Published:26th Apr 2013
Source: Pharmawand

Analyses of Phase II and Phase II clinical data show the favorable impact of OMS 302 (ketorolac and phenylephrine), from Omeros Corporation, on reducing the incidence of miosis (pupil constriction) during intraocular lens replacement (ILR) surgery for Cataracts. In patients receiving standard-of-care preoperative mydriatic topical drops, OMS 302 reduces the occurrence of pupil constriction of 2.5 mm or more and the incidence of the pupil constricting to less than 6 mm in diameter throughout surgery. These two measures are widely recognized by ophthalmologic surgeons as important for successful ILR procedures. "Given the well-recognized need for a product like OMS302 in lens replacement procedures, I expect that it will be widely and rapidly adopted by ophthalmologic surgeons," says Eric B. Donnenfeld, M.D., clinical professor of ophthalmology at New York University and newly elected president of the ASCRS.

Omeros Corporation expects to submit a New Drug Application to the FDA this quarter and a Marketing Authorization Application to the European Medicines Agency in mid-2013. Data was presented at the Annual American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators Symposium and Congress.

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