Beacon Completes Enrollment in VISTA Trial of Laru-zova for XLRP

Beacon Therapeutics has announced the completion of enrollment in its registrational phase 2/3 VISTA trial, which is evaluating laru-zova for the treatment of X-linked retinitis pigmentosa (XLRP). The trial enrolled eligible male patients aged 12 to 50 years across study sites in North America, the United Kingdom, and Australia, ultimately exceeding the company’s initial enrollment projections. Twelve-month topline data from the study are expected in the second half of 2026.

About the VISTA Phase 2/3 Study

The VISTA trial (NCT04850118) is a global, randomized, controlled, masked, multicenter phase 2/3 study designed to assess the efficacy, safety, and tolerability of laru-zova in male patients with XLRP caused by mutations in the RPGR gene. The study is evaluating two dose levels of laru-zova compared to an untreated control group. Key measures include the proportion of participants with improvements in low-luminance visual acuity (LLVA) and mean sensitivity by microperimetry, among other assessments of visual function.

Beacon intends to leverage data from the VISTA trial, in combination with long-term data from its ongoing phase 2 DAWN trial, as well as the phase 1/2 HORIZON and phase 2 SKYLINE studies, to support future regulatory submissions in both the United States and Europe.

Expert Perspectives on the VISTA Program

“The VISTA study has been carefully designed to provide the clinical evidence needed to demonstrate laru-zova’s potential to improve functional vision in patients with XLRP,” said Daniel Chung, DO, MA, Chief Medical Officer of Beacon Therapeutics. “We are applying our deep understanding of both ocular disease and gene therapy by using a highly efficient AAV capsid and a stabilized gene cassette that expresses the full-length RPGR protein, to support better vision outcomes. We are cautiously optimistic about the potential for laru-zova to treat a condition that has long been considered untreatable.”

Progress of the DAWN Study

Beacon Therapeutics is also continuing its phase 2 DAWN trial, an open-label study evaluating laru-zova in the fellow eye of male participants with XLRP who have previously received an AAV vector-based gene therapy delivering the full-length RPGR protein. In May, the company announced 6-month interim results from DAWN, demonstrating greater 2- and 3-line improvements in study eyes compared to previously treated fellow eyes, along with a safety profile consistent with earlier studies.