Ocular Therapeutix enrols first patient in SOL-X wet AMD extension trial
Ocular Therapeutix has enrolled its first patient in SOL-X, a 36-month open-label extension trial evaluating the long-term safety and efficacy of AXPAXLI (OTX-TKI) in wet age-related macular degeneration. The enrolment milestone, confirmed in late April 2026, follows the completion of Ocular's two-year SOL-1 Phase 3 trial, which the company says met its primary endpoints for durability and disease control.
Eligibility for SOL-X is open to patients who have completed their two-year follow-up under either the SOL-1 or SOL-R trials. Enrolled subjects will receive AXPAXLI every 24 weeks — six injections over the 120-week study — with additional anti-VEGF rescue injections permitted at investigator discretion. The primary objectives are long-term safety surveillance and an assessment of whether sustained VEGF suppression reduces the risk of fibrosis and macular atrophy, two forms of irreversible structural damage associated with inconsistent disease control.
The clinical rationale
AXPAXLI is built on Ocular's proprietary ELUTYX bioresorbable hydrogel platform and incorporates axitinib, a small-molecule tyrosine kinase inhibitor. Unlike approved anti-VEGF biologics — which require injections every four to twelve weeks and carry discontinuation rates of up to 40 per cent within the first year — AXPAXLI is designed to deliver continuous VEGF suppression from a single intravitreal implant lasting approximately six months.
Pravin U. Dugel, Ocular's executive chairman, president and chief executive, said the company believes "continuous VEGF suppression with AXPAXLI has the potential not only to maintain vision, but to fundamentally alter the trajectory of disease by reducing the risk of fibrosis and atrophy associated with pulsatile therapies used to treat wet AMD today."
Dilsher S. Dhoot of California Retina Consultants, a SOL-X investigator, described the opportunity to evaluate sustained disease control over multiple years as "exactly what I believe the field has been waiting for," citing progressive damage from inconsistent treatment as a persistent clinical challenge.
Market context and competitive landscape
Wet AMD affects approximately 14.8 million people globally, and represents one of the most commercially significant segments in ophthalmology. The market is currently dominated by Regeneron and Roche-Genentech's approved anti-VEGF agents, with Apellis Pharmaceuticals' pegcetacoplan (Syfovre) and Izervay from Astellas addressing the adjacent dry AMD atrophy indication.
The durability space is intensely contested. Regeneron's high-dose aflibercept (Eylea HD) and Roche's faricimab (Vabysmo) were both positioned on extended-dosing credentials; faricimab targets both VEGF-A and Ang-2 and has demonstrated up to four-monthly dosing in a subset of patients. Against this backdrop, Ocular's claim of six-monthly dosing — if confirmed across a broader population in SOL-X — would represent a meaningful differentiation, provided the safety profile holds over three years of continuous exposure.
The SOL-X dataset will also be important for Ocular's regulatory strategy. AXPAXLI does not yet have FDA approval, and the agency has not publicly confirmed an agreed registrational pathway for the asset. Long-term extension data addressing fibrosis and atrophy — outcomes that current approved therapies have not consistently prevented — could strengthen a label claim beyond simple visual acuity maintenance, which would be commercially and clinically significant.
Ocular's existing commercial product, DEXTENZA, provides a modest revenue base, but the company's near-term valuation is heavily dependent on AXPAXLI's clinical and regulatory trajectory. Investors will track interim SOL-X safety readouts and any FDA meeting disclosures as the key catalysts over the next twelve to eighteen months.