Posted by Michael Wonder on 20 Dec 2023
Ocugen announces OCU400 receives regenerative medicine advanced therapy designation for treatment of retinitis pigmentosa associated with RHO mutations
19 December 2023 - Ocugen today announced that the FDA has granted regenerative medicine advanced therapy designation to Ocugen’s investigational product OCU400 for the treatment of retinitis pigmentosa associated with RHO mutations.
Regenerative medicine advanced therapy designation for OCU400 was based on preliminary clinical data supporting the maintenance and improvement of visual acuity and function in RP patients in the OCU400 -101 Phase 1/2 clinical trial as measured by best corrected visual acuity, low luminance visual acuity and multi-luminance mobility test.
