FDA OKs Dexycu Intraocular Suspension for Cataract Surgery

Megan Brooks

February 13, 2018

The US Food and Drug Administration (FDA) has approved dexamethasone intraocular suspension (Dexycu, Icon Bioscience Inc) for inflammation associated with cataract surgery, according to the company.

Dexycu uses the company'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 cataract surgeon immediately following 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 postsurgery process of patients self-administering medicated eyedrops several times daily over a period of weeks," the company explained.

Dexycu was assessed in a prospective, randomized, double-masked, placebo-controlled, multicenter phase 3 trial involving 394 patients who underwent unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation.

Dexycu was effective in reducing inflammation associated with cataract surgery. The safety profile was similar to that of placebo, the company said.

"The approval of Dexycu represents a significant advancement in ophthalmic drug development, as Dexycu is the first long-acting intracameral product approved by the FDA for treating inflammation following cataract surgery," Eric D. Donnenfeld, MD, clinical professor of ophthalmology, New York University, New York City, and lead investigator for Dexycu clinical studies, said in news release.

"This novel ophthalmic medication offers the cataract surgeon the option of a single administration of a corticosteroid at the site of action. This, in turn, benefits patients by eliminating noncompliance and dosing errors associated with the current practice of relying on the patient dispensing frequent drops following cataract surgery," Donnenfeld added.

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