During a corporate update, EyePoint Pharmaceuticals executives said they expect to launch both Dexycu (dexamethasone intraocular suspension 9%) and Yutiq (fluocinolone acetonide intravitreal implant 0.18 mg) in the first quarter of calendar 2019.
“EyePoint has made significant progress in building its commercial infrastructure in preparation for two ophthalmic product launches in the near-term,” Nancy Lurker, President and Chief Executive Officer of EyePoint Pharmaceuticals, said in a company news release. “As a result of the diligence with which our team has worked to execute on commercial manufacturing scale-up, communicate with payors, build our distribution network and our hub for patient and physician support, I am pleased to be able to announce that along with the launch of Yutiq in the first quarter of calendar 2019, we also now anticipate launching Dexycu in the first quarter of calendar 2019, earlier than initially expected. We are excited to be able to commercialize both these innovative ocular products and we look forward to making a meaningful difference in the established treatment paradigm for cataract surgery and posterior uveitis, which are both areas of high unmet medical need.”
Key Commercial Updates
- EyePoint expects to launch Dexycu (dexamethasone intraocular suspension) 9% in the first quarter of calendar 2019. Dexycu, approved by the FDA on February 9, 2018, is the first and only FDA-approved single dose, sustained release, intracameral steroid for the treatment of postoperative inflammation. In November 2018, the company announced that Centers for Medicare and Medicaid Services (CMS) had assigned a specific and permanent reimbursement J-code through the Healthcare Common Procedure Coding System (HCPSC) for Dexycu. The code, J1095, will become effective on January 1, 2019, and will replace the previously issued C-code for Dexycu (C9034) that became effective on October 1, 2018.
- The company expects to launch Yutiq (fluocinolone acetonide intravitreal implant) 0.18 mg in the first quarter of calendar 2019. Yutiq was approved by the FDA on October 12, 2018, and is the first long-lasting, FDA approved micro-insert for up to 3 years of continuous control in chronic, noninfectious posterior segment uveitis, the third leading cause of blindness in the United States. The company recently presented positive Yutiq 24-month efficacy and safety data at the American Academy of Ophthalmology (AAO) 2018 Annual Meeting in October, showing a significantly increased likelihood of achieving and maintaining inflammation control for Yutiq compared to sham, highlighting Yutiq’s ability to decrease the rate of uveitic recurrences.