Ocular Therapeutix has enrolled the first participant in SOL-X, a 36‑month open-label extension study evaluating long-term safety and outcomes of AXPAXLI (OTX‑TKI) in wet AMD, following completion of two-year follow-up in the Phase 3 SOL‑1 trial or the SOL‑R study. Participants will receive intravitreal AXPAXLI every 24 weeks at prespecified visits, with interim assessments every 12 weeks and investigator‑directed supplemental anti‑VEGF as needed.
The move is a bid to convert the Phase 3 durability signal observed in SOL‑1 into a broader, disease‑management narrative. By tracking visual acuity, fibrosis, and macular atrophy over three additional years, Ocular aims to validate continuous VEGF suppression as a clinically meaningful differentiator versus the prevailing “pulsatile” injection paradigm. The trial also includes an exploratory analysis of patients who initiated therapy later after prior aflibercept exposure in SOL‑1 or SOL‑R, positioning the company to argue for earlier adoption if outcomes diverge by timing of AXPAXLI initiation.
Strategically, the extension study is about more than safety accumulation. The wet AMD market has tilted toward longer-interval regimens and sustained delivery, with high‑dose anti‑VEGF, refillable or implantable delivery, and gene therapy candidates all competing to reduce visit burden while maintaining disease control. Ocular’s bet is a bioresorbable axitinib hydrogel capable of true q24w dosing that could simplify long‑term management without the procedural complexity of implants or the permanence of gene therapy. If SOL‑X links sustained suppression to lower rates of fibrosis or atrophy, it would strengthen a disease‑modification claim few anti‑VEGF‑based approaches have convincingly made.
For sites and CROs, SOL‑X is operationally straightforward but exacting. Extension enrollment from known, recently active cohorts should smooth start‑up and retention. A q24w dosing schedule with standardized q12w imaging pushes visits toward a manageable cadence, potentially easing chair-time pressures relative to monthly regimens. However, the allowance for supplemental anti‑VEGF at investigator discretion will inject heterogeneity that must be tightly documented and centrally adjudicated to preserve interpretability. Capturing fibrosis and atrophy trajectories will require consistent multimodal imaging and harmonized grading—an execution risk that can blur otherwise strong durability narratives if not standardized upfront.
Regulatory and commercial impact will hinge on how SOL‑X augments the core SOL‑1 dataset. As a noncomparative extension, SOL‑X cannot answer efficacy questions definitively, but it can derisk chronic safety, inform dose-interval labeling, and support payer arguments around adherence and resource use. The exploratory “delayed initiation” analysis is notable but vulnerable to selection and confounding inherent in post‑randomization treatment pathways; any early‑start advantage will need to be corroborated in prospectively defined analyses or real‑world evidence. Meanwhile, claims around reducing atrophy or fibrosis will face a high evidentiary bar amid ongoing debate about long‑term VEGF suppression and retinal tissue health.
Near term, watch enrollment velocity and retention from SOL‑1/SOL‑R as a proxy for field enthusiasm and feasibility of the q24w cadence. The most decision-relevant readouts will be durability of visual acuity gains and the rate and timing of supplemental injections, followed by adjudicated fibrosis and atrophy signals. Safety—particularly intraocular inflammation, IOP changes, and procedure‑related events—will be scrutinized against emerging sustained‑delivery benchmarks. The broader question is whether extension‑phase data can shift practice toward earlier, sustained therapy, or whether payers and clinicians will wait for head‑to‑head or real‑world comparators to validate a disease‑modifying claim.
Source link: https://www.globenewswire.com/news-release/2026/04/29/3283623/0/en/Ocular-Therapeutix-Announces-First-Patient-Enrolled-in-SOL-X-Long-Term-Extension-Trial-for-AXPAXLI-in-Wet-AMD.html
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.
