FDA approves Dexycu for inflammation associated with cataract surgery.- Icon Bioscience.
Icon Bioscience announced that the FDA has approved IBI�s New Drug Application (NDA) for Dexycu (dexamethasone intraocular suspension), a dropless, long-acting therapeutic for treating inflammation associated with cataract surgery. Dexycu offers new treatment of inflammation in post cataract surgery because it is applied as a single injection administered at the conclusion of surgery. It employs IBI�s Verisome technology to dispense a biodegradable extended-release formulation of dexamethasone into the posterior chamber of the eye.
Approval follows positive data from its pivotal Phase III clinical trial for Dexycu in Cataract Surgery. The results of the trial showed that Dexycu is highly effective in treating inflammation post cataract surgery. In this trial, Dexycu showed unprecedented efficacy in reducing inflammation associated with cataract surgery, with a safety profile similar to that of placebo. It could prove to be an important new therapy as an alternative to frequent corticosteroid drop instillation in post cataract surgical care.
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