Intraocular therapeutics manufacturer Icon Bioscience Inc., focusing on innovative eye care, recently obtained U.S. Food and Drug Administration acceptance of its new drug application for Dexycu, with full approval anticipated in 2018.
Dexycu is used specifically to combat inflammation following cataract surgery. Under the Prescription Drug User Fee Act, the FDA set a target date for Feb. 12, 2018, indicating that the agency considers Icon’s NDA adequate for more thorough review.
“This is an important landmark event in advancing Dexycu through the regulatory process into the marketplace,” Icon’s President and CEO Dr. David Tierney said. “We look forward to working with the FDA during this review process to obtain marketing approval.”
Dexycu uses Icon’s proprietary Verisome technology in a sustained-release version of dexamethasone, an anti-inflammatory treatment dispensed by a single injection directly after cataract surgery into the eye’s anterior chamber.
Verisome’s extended-release drug delivery reduces maintenance for patients recovering from eye surgery. Benefits of the one-time injection include avoiding dosage errors among cataract patients, who are often elderly.
“The technology’s exceptional versatility can support products individually formulated to meet the particular clinical requirements of a given active agent targeting a specific ophthalmic disease,” Icon representatives said.
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