LANDSCAPE open-label trial to evaluate safety of laru-zova administered bilaterally
LONDON and CAMBRIDGE, Mass., Dec. 16, 2025 (GLOBE NEWSWIRE) -- Beacon Therapeutics Holdings Limited ('Beacon Therapeutics' or 'the Company'), a leading clinical-stage biotechnology company with a mission to save and restore vision in people with rare and prevalent ocular diseases, today announced the treatment of the first patient in its LANDSCAPE clinical trial, an open-label study evaluating the safety of bilateral administration of laru-zova (laruparetigene zovaparvovec), a potential best-in-class gene therapy being investigated for the treatment of patients with X-linked retinitis pigmentosa (XLRP).
"Following the completion of enrollment in our registrational VISTA trial of laru-zova in XLRP earlier this year, the initiation of our LANDSCAPE trial, which will access the safety of bilateral dosing within a short period of time, is another important step toward offering patients a potential new treatment for this devastating inherited retinal disease," said Daniel Chung, D.O, M.A., Chief Medical Officer of Beacon Therapeutics. "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 primary objective of LANDSCAPE) is to evaluate the safety of laru-zova, when administered in both eyes. The study will also evaluate changes in visual function after administering bilaterally via subretinal injection. LANDSCAPE is enrolling males between the ages of 12 and 50 with a confirmed diagnosis of XLRP across sites in the United States.
XLRP is an inherited retinal disease that leads to progressive vision loss and legal blindness, with no available treatment options. It is typically caused by mutations to the retinitis pigmentosa GTPase regulator (RPGR) gene and affects about 10% of the 100,000 retinitis pigmentosa patients in the United States. Laru-zova is a potential best-in-class gene therapy designed to restore the natural function of both rods and cones in XLRP by delivering a functional copy of the RPGRORF15 gene designed to produce the full-length protein.
The trial builds on positive interim data from the Phase 2 DAWN and SKYLINE trials presented at EURETINA 2025, which demonstrated sustained improvements across several key measures of visual function, including low luminance visual acuity and microperimetry, in patients treated with laru-zova. Laru-zova was generally well-tolerated by SKYLINE participants through month 36 and DAWN participants at 9 months or beyond. Additionally, Beacon recently completed enrollmentin the pivotal VISTA trial of laru-zova and expects to report topline data in the second half of 2026.
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About laru-zova
Laru-zova (laruparetigene zovaparvovec) is a potential best-in-class gene therapy currently being investigated for the treatment of patients with X-linked retinitis pigmentosa (XLRP). Laru-zova has the potential to restore the natural function of both rods and cones in XLRP by delivering a functional copy of the RPGRORF15 gene designed to produce the full-length protein. Laru-zova has Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration (FDA), Priority Medicines (PRIME) designation from the European Medicines Agency (EMA), Innovative Licensing and Access Pathway (ILAP) from the UK's Medicines and Healthcare products Regulatory Agency (MHRA), as well as Orphan Drug Designation (ODD) from the FDA and EMA.
Laru-zova is investigational and has not been approved by FDA for use.
About XLRP
X-linked retinitis pigmentosa (XLRP) is an inherited retinal disease that predominantly affects males, typically caused by mutations in the RPGR gene. The mutations result in progressive photoreceptor loss over time and visual dysfunction beginning in childhood, eventually leading to blindness and impacting quality of life with no approved treatments. There are an estimated 100,000 people living with retinitis pigmentosa (RP) in the United States today with XLRP RPGR cases accounting for an estimated 10% of all RP cases.
About Beacon Therapeutics
Beacon Therapeutics is a clinical-stage biotechnology company dedicated to saving and restoring sight for people living with rare and prevalent ocular diseases. The Company is harnessing the transformative power of gene therapy to deliver the most meaningful outcomes for severe ocular diseases. Beacon's pipeline currently targets devastating blinding retinal diseases such as X-linked retinitis pigmentosa (XLRP) and geographic atrophy.
Beacon Therapeutics' investors include Forbion, Syncona Limited, Oxford Science Enterprises, TCGX and Advent Life Sciences, among others. Learn more about Beacon Therapeutics at beacontx.comand follow on LinkedInfor more updates.
