Ocular Therapeutix announced the commercial launch in the United States of Dextenza (dexamethasone ophthalmic insert) 0.4 mg for the treatment of ocular inflammation and pain following ophthalmic surgery. Dextenza is the first FDA-approved intracanalicular insert that enables the delivery of drug to the surface of the eye, obviating the need for monthly regimen of steroid eye drops. Dextenza originally received FDA approval in November 2018 for the treatment of ocular pain following ophthalmic surgery.
The launch comes less than 2 weeks after the June 21 announcement of FDA approval of a supplemental new drug application (sNDA) for Dextenza for the treatment of ocular inflammation following ophthalmic surgery. Dextenza is now the only sustained release steroid product approved for the treatment of both ocular inflammation and pain following ophthalmic surgery.
The initial launch of Dextenza is supported by activation of its C-code, C9048. A C-code is a product code established by CMS for the Hospital Outpatient Prospective Payment System (HOPPS) used to report claims for hospital outpatient department and ambulatory surgical center services and procedures. The July 1, 2019 activation of the C-code facilitates the reimbursement of Dextenza until such time as CMS may potentially approve a J-code and such approval becomes effective. In May 2019, the company announced that CMS has included Dextenza on its list of products that have been preliminarily recommended for a new dedicated Healthcare Common Procedure Coding System (HCPCS) J-code which, if granted, would become effective January 1, 2020. A J-code represents a permanent product code that could be used across settings of care.
“We are extremely proud to be bringing Dextenza to market in the U.S.,” Antony Mattessich, President and Chief Executive Officer, said in a company news release. “With reimbursement solidified through a unique C-code, the addition of inflammation to our label, and our direct, highly-experienced commercial team in place, we believe we are well-prepared for the launch of Dextenza. Dextenza represents a novel new treatment option that we believe offers significant value to both patients and physicians and we are excited for its potential in the market.”
There are approximately 6 million steroid prescriptions written each year for ocular surgeries in the United States. Ocular’s commercial launch of Dextenza will initially focus on the roughly 2 million cataract procedures performed annually under Medicare Part B which is the market segment where Dextenza has full reimbursement established following the effectiveness of the C-code and pass-through payment status.