Vista - Phase 2/3 Currently Enrolling
The Vista clinical trial is planned randomized, controlled, masked, multi-center pivotal study evaluating the efficacy, safety, and tolerability of 2 doses of laru-zova (AGTC-501) compared to an untreated control group. Vista will enroll male patients with a confirmed diagnosis of X-Linked Retinitis Pigmentosa.
Dawn - Phase 2 Open-label Currently Enrolling
The Dawn clinical trial is a non-randomized, open-label study of laru-zova (AGTC-501) in participants with XLRP who have previously been treated with a full-length AAV-vector based gene therapy targeting RPGR protein. The purpose of Dawn is to assess 2 different doses of the study drug for efficacy, safety, and tolerability in a participant’s eye that was not previously treated (fellow eye) for XLRP. Laru-zova has been well-tolerated by all participants and shows promising early improvements in low luminance visual acuity (LLVA), a critical measure of visual function, at the 3-month analysis.
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SKYLINE - Phase 2 Expansion ENROLLMENT COMPLETE
The Skyline clinical trial is an ongoing Phase 2 follow-on study for male patients ages 8-50 years (inclusive) that completed enrollment in 2022. Fourteen male participants received one of two dose levels of laru-zova (AGTC-501) in one eye to further assess safety and potential efficacy of laru-zova gene therapy. Laru-zova was generally safe and well-tolerated and showed robust improvements in mean retinal sensitivity at the 24-month analysis.
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Horizon - Phase 1/2 ENROLLMENT COMPLETE
The Horizon clinical trial is a Phase 1/2 study that completed enrollment of 29 male participants and all participants are in long-term follow-up. Participants received a single dose of laru-zova (AGTC-501) in one eye to obtain initial data about safety and potential efficacy of laru-zova gene therapy. The 36-month post treatment data results demonstrate laru-zova is well tolerated.