Beacon Therapeutics has treated the first patient in its open-label LANDSCAPE trial of the potential gene therapy, laru-zova (laruparetigene zovaparvovec), for X-linked retinitis pigmentosa (XLRP).
XLRP is an inherited retinal condition that primarily impacts males and is most often caused by mutations in the retinitis pigmentosa GTPase regulator (RPGR) gene.
The main aim of the trial is to assess the safety of the therapy when administered in both eyes.
In addition, it will examine visual function changes following bilateral subretinal injection of the therapy.
The study is enrolling male participants aged between 12 and 50 years who have a confirmed XLRP diagnosis in the US sites.
It builds upon encouraging interim data from the Phase II DAWN and SKYLINE studies, which showed sustained improvements in key visual function measures, such as low luminance visual acuity and microperimetry, in the laru-zova-treated patients.
Beacon Therapeutics' chief medical officer Daniel Chung said: “This new study builds upon our extensive clinical experience across multiple trials and will contribute to one of the most significant data packages for a gene therapy in ocular diseases.”
The therapy was said to be generally well-tolerated by participants in the SKYLINE study through month 36 and by those in the DAWN trial at nine months or later.
In July 2025, the company completed enrolment in the VISTA trial of the therapy, with topline data anticipated in the second half of next year.
Laru-zova has received several regulatory designations, including fast track and regenerative medicine advanced therapy (RMAT) status from the US Food and Drug Administration (FDA), European Medicines Agency’s (EMA) priority medicines (PRIME) designation, and the UK Medicines and Healthcare products Regulatory Agency’s innovative licensing and access pathway (ILAP).
It also holds orphan drug status from both the FDA and EMA.
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