Interim Phase 2 data for laru-zova have shown sustained gains on low-luminance visual acuity and microperimetry, with participants generally tolerating treatment through 36 months in SKYLINE and at nine months or longer in DAWN. Those signals frame Beacon Therapeutics’ next step: generating evidence that the same gene therapy can be dosed in both eyes safely and within a short interval.
Beacon has dosed the first patient in LANDSCAPE (NCT07174726), an open-label U.S. study assessing bilateral administration of laru-zova via subretinal injection in males aged 12 to 50 with genetically confirmed X-linked retinitis pigmentosa. The primary objective is safety; the study will also track functional vision changes after bilateral dosing. The move follows completion of enrollment in VISTA, the company’s registrational XLRP trial, with topline data expected in the second half of 2026. Laru-zova delivers a functional RPGR ORF15 sequence and holds RMAT, Fast Track, PRIME, and ILAP designations.
Strategically, bilateral dosing is the gating item for real-world adoption if VISTA reads out positively. In ocular gene therapy, the first-eye administration can prime systemic immunity and complicate treatment of the fellow eye. Sponsors historically mitigate that risk by spacing procedures, modulating steroids, or limiting dosing to one eye for pivotal packages. Beacon is tackling the issue head-on, aiming to generate a contemporaneous dataset on bilateral safety and functional impact that could inform labeling, perioperative management, and payer discussions. It is also a differentiation play in a field with mixed precedents on XLRP efficacy endpoints and durability, where operational simplicity and predictable surgical workflows may matter as much as incremental efficacy.
For sites, LANDSCAPE tests the operational feasibility of scheduling two retinal surgeries in close succession, standardizing subretinal delivery while managing immunologic and inflammatory risks. Retina centers will need tight playbooks around perioperative steroids, OCT-based inflammation monitoring, and adverse event adjudication, alongside consistent microperimetry and low-luminance acuity testing that can withstand regulatory scrutiny. CROs and imaging vendors should expect heavier demands on certified readers and device calibration to support sensitivity analyses across both eyes and timepoints. Regulators will look for a clean inflammatory profile, clarity on the interval between eyes, and evidence that bilateral dosing does not blunt efficacy in the second eye. If bilateral use is supported, payers will weigh the clinical value of treating both eyes against vector supply, surgical capacity, and budget impact.
The near-term watchlist centers on operational specifics that Beacon has not yet detailed: the exact inter-eye interval, steroid regimens, rates and severity of ocular inflammation, and neutralizing antibody kinetics post-first-eye dosing. Read-through from LANDSCAPE could shape VISTA’s interpretability if fellow eye effects or immune responses confound functional endpoints. Over the next 18 months, the company’s ability to demonstrate consistent improvements on regulator-acceptable measures—particularly microperimetry-derived sensitivity metrics—with durable safety will determine whether RMAT-enabled interactions translate into a streamlined path to BLA. If VISTA delivers and LANDSCAPE de-risks bilateral administration, expect discussions to pivot to label scope, postmarketing commitments for long-term safety, and the practicalities of scaling surgical delivery across a limited pool of trained sites. Conversely, any signal of second-eye attenuation or heightened inflammation would likely constrain labeling to unilateral or extended-interval dosing, adding friction to adoption even with a positive efficacy readout.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
