Ocugen: FDA Grants Rare Pediatric Disease Designation For OCU410ST

(RTTNews) - Ocugen, Inc. (OCGN) announced the FDA has granted Rare Pediatric Disease Designation for OCU410ST for the treatment of ABCA4-associated retinopathies including Stargardt disease, retinitis pigmentosa, and cone-rod dystrophy. With this designation for OCU410ST, Ocugen may be awarded a Priority Review Voucher, if the PRV program is reauthorized by the U.S. Congress.

Ocugen said it is committed to advancing the OCU410ST program through clinical development and plans to initiate the Phase 2/3 pivotal confirmatory trial in the next few weeks with a target Biologics License Application filing in 2027.

Shares of Ocugen are up 4% in pre-market trade on Tuesday.

For More Such Health News, visit rttnews.com.