Date: 2014-10-06
Type of information: Completion of the trial
phase: 3
Announcement: completion of the trial
Company: Icon Bioscience (USA - CA)
Product: IBI-10090
Action
mechanism: non-steroidal anti-inflammatory drug/glucosteroid. IBI-10090 employs Icon’s Verisome drug delivery platform to dispense a long-acting, biodegradable formulation of the anti-inflammatory agent dexamethasone into the anterior chamber of the eye through a single injection administered immediately following surgery. IBI-10090 has been specifically designed to deliver a controlled release of the active agent over a sufficient time to provide an alternative to the current standard treatment regimen involving a comparatively burdensome process of patient administered eye drops applied topically several times daily for an extended period of time.
Disease: ocular inflammation following cataract surgery
Therapeutic area: Ophtalmological diseases - Inflammatory diseases
Country:
Trial details:
Latest
news: * On October 6, 2014, Icon Bioscience, a specialty biopharmaceutical company focused on utilizing its Verisome® drug-delivery platform to develop unique intraocular eye-care therapeutics, announced that the last patient has completed treatment in its pivotal Phase 3 study IBI-10090. Top-line data is expected to be reported in the fourth quarter of 2014. Employing Icon’s Verisome technology, IBI-10090 is designed to provide a controlled, sustained-release formulation of the anti-inflammatory agent dexamethasone into the anterior chamber of the eye through a single injection administered immediately following cataract surgery. This Phase 3 study involved 390 patients in a randomized, double blind, andplacebo-controlled study. * On June 30, 2014, Icon Bioscience announced the completion of patient enrollment in its pivotal phase 3 study of IBI-10090, approximately four months ahead of projected timelines.