FDA Accepts Icon Bioscience NDA Filing for Dexycu for Treatment of Inflammation Associated with Cataract Surgery.
M2 PHARMA-June 27, 2017-FDA Accepts Icon Bioscience NDA Filing for Dexycu for Treatment of Inflammation Associated with Cataract Surgery
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- US-based ophthalmic pharmaceuticals specialist Icon Bioscience Inc. has received notification from the US Food and Drug Administration that the agency has accepted for filing its recently submitted new drug application for Dexycu (IBI-10090), the company said.
In accordance with the FDA's standard review designation, the agency has established a user fee goal date under the Prescription Drug User Fee Act (PDUFA) of February 12, 2018.
Such notification indicates that FDA has determined that the NDA for Dexycu is sufficiently complete to permit a substantive review by the agency, and the PDUFA action date targets the potential approval of Dexycu in early 2018.
Dexycu employs Icon's Verisome technology to dispense a sustained-release, biodegradable formulation of the anti-inflammatory agent dexamethasone directly into the anterior chamber of the eye through a single injection administered by the physician immediately following cataract surgery.
Dexycu has been developed to help patients, in a largely elderly population, avoid noncompliance and dosing errors associated with the current standard-of-care which relies on a burdensome post-surgery process of patients self-administering medicated eye-drops several times daily over a period of weeks.
Icon Bioscience is a privately held specialty biopharmaceutical company focused on the development and commercialization of unique ophthalmic pharmaceuticals based on its patented and proprietary Verisome extended-release drug delivery technology.
The technology encompasses a broad number of related but distinct drug delivery systems capable of incorporating an extensive range of active agents, including small molecules, proteins and monoclonal antibodies. This drug delivery system controlls the release of medication within the eye for up to a year through the administration of a single injection.
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|Date:||Jun 27, 2017|
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