2014年6月3日讯 /生物谷BIOON/ --Omeros生物技术公司最近宣布公司开发的治疗眼部疾病药物Omidria获得FDA批准用于白内障手术以及人造晶状体移植手术治疗中。这也是Omeros公司成立20年以来获得的首个FDA上市许可批准。Omidria是一种瞳孔放大剂与抗炎症药物结合的药物。研究人员表示，瞳孔缩小和病人术后疼痛是白内障手术等眼科疾病手术中常见问题，这些问题会极大影响手术的顺利进行，而Omidria能够明显缓解这一症状。FDA未对Omidria提出明确的上市后承诺，仅要求使用这一药物的儿童患者提供相应研究信息。
Omeros公司 CEO Dr. Gregory Demopulos表示，今后公司还会有一系列药物提交FDA审核，不过在这之前，公司将先努力促使欧洲医药管理部门批准Omidria上市。（生物谷Bioon.com）
详细英文报道：
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.
