Beacon Therapeutics Completes Enrollment in Registrational Phase 2/3 VISTA Trial of laru-zova for Patients with XLRP
Beacon Therapeutics announced it has completed enrollment in its registrational phase 2/3 VISTA trial evaluating laru-zova for the treatment of X-linked retinitis pigmentosa (XLRP).
The study enrolled eligible male patients aged 12 to 50 across sites in North America, the United Kingdom, and Australia, exceeding the initial enrollment projection. Twelve month topline data from this trial are expected in the second half of 2026.
The VISTA trial (NCT04850118) is a global, randomized, controlled, masked, multicenter phase 2/3 study designed to evaluate the efficacy, safety, and tolerability of laru-zova in male patients with XLRP caused by mutations in the RPGR gene. The trial is assessing two dose levels of laru-zova compared to an untreated control group, evaluating the proportion of participants with improvement in low-luminance visual acuity (LLVA) and mean sensitivity as observed by microperimetry, among other measures of visual function.
Beacon plans to use the data from the VISTA trial, alongside long-term data from the ongoing phase 2 DAWN trial, the phase 1/2 HORIZON and phase 2 SKYLINE studies to support regulatory submissions in the United States and Europe.
“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,” Daniel Chung, DO, MA, Chief Medical Officer of Beacon Therapeutics, said in a company news release. “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.”
Beacon continues to progress its phase 2 DAWN trial, an open-label study of laru-zova in the fellow eye of male participants with XLRP who have previously been treated with 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, and a safety profile consistent with previous studies.