EyePoint Pharmaceuticals (NSDQ:EYPT) said this week that the Centers for Medicare and Medicaid Services approved transitional pass-through status and reimbursement of its dexamethasone intraocular suspension, Dexycu.
The FDA-approved product is designed to treat inflammation following cataract surgery using a single, intraocular dose of long-acting dexamethasone.
“The receipt of pass-through status and the assignment of a C-code from CMS marks another important step forward in our commercialization preparation for Dexycu,” president & CEO Nancy Lurker said in prepared remarks.
“Our team continues to make progress on our commercialization strategy, hiring and scale-up initiatives in support of our planned commercial launch expected in the first half of 2019. We believe Dexycu has the potential to address the unmet need and limitations of steroid drops, the current standard of care available for patients to treat inflammation following eye surgery, by providing Dexycu as a convenient and long-acting single injection alternative therapy,” she added.
Dexycu was developed at Icon Bioscience. The company won FDA approval for the product in February. In March, pSivida forked over $61 million to combine with Icon and the two businesses rebranded as EyePoint Pharmaceuticals.
EYPT shares closed at $2.32 apiece yesterday, up 9.4%.