Published on 7 Apr 2023 on Benzinga via Yahoo Finance
Ocugen Highlights Interim Data From Gene Therapy Study For Genetic Vision Loss Disorder
Ocugen Inc (NASDAQ: OCGN) announced preliminary data among retinitis pigmentosa (RP) participants treated in the first two cohorts of the Phase 1/2 trial of OCU400 for RP associated with NR2E3 and Rhodopsin (RHO) mutations and Leber Congenital Amaurosis (LCA) with mutation(s) in the CEP290 gene.In Cohort 1 and 2 of the clinical trial, 7 participants received a unilateral subretinal injection of either a low dose (1.66 x 1010 vg/mL) or medium dose (3.33 x 1010 vg/mL) OCU400, respectively.The preliminary data analysis evaluated 9-month follow-up data for three subjects [Cohort 1] and 6-month follow-up data for four subjects [N=1 from Cohort 1 and N=3 from Cohort 2].Results showed a favorable safety profile and visual improvements after treatment with OCU400 as measured by multi-luminance mobility testing (MLMT) and best-corrected visual acuity assessment (BCVA).100% of treated eyes showed a stable or improved MLMT score trend;5 of 7 (71.4%) OCU400 treated eyes demonstrated a one or more Lux level improvement in MLMT score compared to 28.6 % of untreated eyes;66.7% (2 of 3) of OCU400 treated eyes in Cohort 1 with a 9-month follow-up demonstrated a two or more Lux level improvement in MLMT score compared to none of the untreated eyes.3 of 7 (42.9%) OCU400 treated eyes demonstrated 8-11 letters of improvement in BCVA score compared to none of the untreated eyes.Ocugen will continue to monitor long-term safety and efficacy data. The company intends to initiate a Phase 3 trial near the end of 2023.Price Action: OCGN shares are down 5.23% at $0.81 on the last check Friday.
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