EyePoint Pharmaceuticals announced the commercial launch of Dexycu (dexamethasone intraocular suspension) 9% in the United States. Dexycu is the first and only FDA approved intraocular steroid for the treatment of postoperative inflammation and is administered as a single dose at the end of cataract surgery.
Dexycu was initially launched to leading cataract surgery experts to ensure proper training on Dexycu’s administration and is now available to the broader ophthalmology community. The Centers for Medicare and Medicaid Services (CMS) has assigned a specific and permanent reimbursement J-code for Dexycu, J1095, through the Healthcare Common Procedure Coding System (HCPCS) that became effective on January 1, 2019. The J-code has replaced the previously issued C-code for Dexycu (C9034) that became effective on October 1, 2018.
Dexycu is the first sustained-release, intracameral steroid approved by the FDA for the treatment of postoperative inflammation. Cataract surgery is the most frequent surgical procedure in the United States, with approximately 4.8 million performed annually. Dexycu employs the company’s Verisome sustained-release drug delivery technology to deliver a biodegradable formulation of the steroid dexamethasone behind the iris in the inferior portion of the posterior chamber of the eye via a single injection at the end of surgery. In most patients, this may eliminate self-administering steroid eye drops up to four times a day for several weeks on a titrated schedule in a primarily elderly patient population. The cumulative percentage of subjects receiving rescue medication of ocular steroid or nonsteroidal anti-inflammatory drug (NSAID) at day 30 was significantly lower in the Dexycu (517 mcg) treatment group (20%; n=31/156) compared to placebo (54%; n=43/80).