Ocugen Receives Health Canada Approval To Initiate Phase 3 LiMeliGhT Trial For OCU400
2024-08-19
2662
(fxcue news) - Biotechnology company Ocugen, Inc. (OCGN) announced Monday that Health Canada provided a "No Objection Letter" to initiate the OCU400 Phase 3 liMeliGhT clinical trial in Canada. OCU400 is a modifier gene therapy product candidate being developed for retinitis pigmentosa (RP).
Currently there are approximately 10,000 patients in Canada with RP and 1.6 million patients globally. The Phase 3 study in Canada will enroll up to 50 subjects across a maximum of 5 sites for the liMeliGhT clinical trial.
The Health Canada trial will run in parallel with the U.S. FDA trial.
The primary endpoint for the study is an enhanced sensitive and specific measurement of functional vision test - Luminance Dependent Navigation Assessment (LDNA). Specifically, the primary endpoint is a measurement of the change in functional vision from baseline to week 52 as measured by the ability of a study participant to navigate through a maze (the LDNA).
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