Ocugen Highlights Interim Data From Gene Therapy Study For Genetic Vision Loss Disorder

Ocugen Inc 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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