EyePoint Pharmaceuticals announced that it has commercially launched 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 is intended to replace the use of steroid eyedrops which have a dosing regimen that, depending on the brand, can require self-administration for up to four times a day and titrating down over 4 weeks. This complicated dosing regimen can often lead to poor patient compliance.
The launch of Dexycu will be phased, with the initial phase being to leading cataract surgery experts, to ensure proper training on Dexycu’s administration ahead of its wider availability in the 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 will replace the previously issued C-code for Dexycu (C9034) that became effective on October 1, 2018. EyePoint Assist, the company-sponsored program designed to ensure access to Dexycu, is available for eligible patients in need of financial assistance.
“EyePoint is proud to announce the US commercial launch of our second innovative ophthalmic product, Dexycu, which is now available to cataract surgery patients to treat inflammation that occurs after this common surgical procedure. There are approximately 4.8 million cataract surgeries a year in the US,” Nancy Lurker, President and Chief Executive Officer of EyePoint Pharmaceuticals, said in a company news release. “Dexycu offers a single-dose, sustained release treatment option conveniently administered at the end of cataract surgery which can eliminate the complicated and burdensome steroid eyedrop regimen following surgery.”
Dexycu is the first long-acting intraocular steroid approved by the FDA for the treatment of postoperative inflammation. Dexycu employs the company’s Verisome sustained-release drug delivery technology to deliver a biodegradable extended-release formulation of the steroid dexamethasone into the posterior chamber of the eye via a single injection at the end of surgery, eliminating the burden of self-administering steroid eye drops up to four times a day for several weeks on a titrated schedule, in a primarily elderly patient population.