2014年6月3日訊 /生物谷BIOON/ --Omeros生物技術(shù)公司最近宣布公司開發(fā)的治療眼部疾病藥物Omidria獲得FDA批準用于白內(nèi)障手術(shù)以及人造晶狀體移植手術(shù)治療中。這也是Omeros公司成立20年以來獲得的首個FDA上市許可批準。Omidria是一種瞳孔放大劑與抗炎癥藥物結(jié)合的藥物。研究人員表示，瞳孔縮小和病人術(shù)后疼痛是白內(nèi)障手術(shù)等眼科疾病手術(shù)中常見問題，這些問題會極大影響手術(shù)的順利進行，而Omidria能夠明顯緩解這一癥狀。FDA未對Omidria提出明確的上市后承諾，僅要求使用這一藥物的兒童患者提供相應研究信息。

Omeros公司 CEO Dr. Gregory Demopulos表示，今后公司還會有一系列藥物提交FDA審核，不過在這之前，公司將先努力促使歐洲醫(yī)藥管理部門批準Omidria上市。（生物谷Bioon.com）

 

詳細英文報道：

Omeros ($OMER) has landed FDA approval for its eye drug Omidria for use during cataract surgery or other procedures that involve replacing the intraocular lens of the eye with a new artificial lens.

It's a long-awaited leap into the commercial realm for Omeros, which has been a company for 20 years without an FDA win up until now.

Omidria is a combination of a mydriatic, or pupil-dilating, agent designed to maintain pupil size by preventing intraoperative miosis, or pupil constriction, and an anti-inflammatory meant to reduce postoperative pain. The drug is intended to be used in addition to standard irrigation solution during cataract surgery and other intraocular lens replacement procedures, like refractive lens exchange, which collectively make up the most common surgical procedures performed in the U.S. at nearly 4 million annually.

"Miosis and postoperative pain are frequent and largely unpredictable, and their occurrence can make the procedure more difficult for the surgeon and unpleasant postoperatively for the patient. While not changing their surgical routine, the use of Omidria will better allow ophthalmic surgeons to control the operative experience and, I expect, will improve surgical outcomes," said Dr. Richard Lindstrom, adjunct clinical professor emeritus at the University of Minnesota's Department of Ophthalmology and past president of both the American Society of Cataract and Refractive Surgery and the International Society of Refractive Surgery.

The approval comes with no postmarketing commitments other than a previously agreed-upon study of Omidria for use in pediatric patients. If successful, the drug would be eligible for an additional 6 months of marketing exclusivity in the U.S., according to Omeros.

Omeros CEO Dr. Gregory Demopulos said Omidria's nod marks the first in a likely series of FDA approvals for the company. But first, Omeros has its sights on gaining European approval for Omidria, securing Medicare reimbursement and successfully launching the product in the U.S. in late summer or early fall.

Also in Omeros' pipeline is OMS824, a phosphodiesterase 10 (PDE10) inhibitor, which was granted fast-track designation by the FDA back in February for the treatment of cognitive impairment in patients with Huntington's disease.