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FDA OKs Single-Shot Dexycu to Replace Eye Drops After Cataract Surgery
The FDA has approved dexamethasone intraocular suspension (Dexycu, Icon Bioscience, Inc.), a long-acting treatment for inflammation associated with cataract surgery that allows patients to dispense with weeks of self-administered eye drops.
Under the current standard of care for inflammation associated with the surgery, patients (many of them elderly) must self-administer medicated eye drops several times daily for weeks. Dexycu, given as a single injection at the conclusion of surgery, employs Icon Bioscience’s Verisome technology to dispense a biodegradable extended-release formulation of dexamethasone into the posterior chamber of the eye.
Dexycu is the first long-acting intracameral product approved by the FDA for treating inflammation following cataract surgery, said Eric D. Donnenfeld, MD, Clinical Professor of Ophthalmology at New York University and lead investigator for Dexycu clinical studies. “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.”
The FDA-approved dose is 5 mcL.
Clinical efficacy was evaluated in a randomized, double-masked, placebo-controlled trial (NCT02006888) in which subjects received Dexycu or placebo. A dose of 5 mcL of Dexycu (equivalent to 517 mcg of dexamethasone), a dose equivalent to 342 mcg of dexamethasone, or a vehicle placebo was administered by the physician at the end of the surgical procedure. The primary efficacy endpoint was the proportion of patients with anterior chamber cell clearing (i.e., cell score = 0) on postoperative day 8. The percentage of patients with anterior chamber clearing at day 8 was 20% in the placebo group, and 57% and 60% in the 342 and 517 mcg treatment groups, respectively. The percentage of subjects receiving rescue medication of ocular steroid or nonsteroidal anti-inflammatory drugs was significantly lower at days 3, 8, 15, and 30 in the 342 and 517 mcg treatment groups compared with placebo.
Verisome extended-release drug delivery technology encompasses a 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 platform can control the release of medication within the eye for up to a year through the administration of a single injection.