At a Glance
- Ocular announces Phase 3 success: SOL-1 (NCT06223958) meets superiority primary endpoint vs. aflibercept under FDA SPA.
- Topline shows durability: AXPAXLI outperforms aflibercept in vision maintenance through Week 52 with high rescue-free rates.
- Strong safety profile: Well-tolerated no treatment-related serious AEs, vasculitis, or implant issues through Week 52.
- NDA filing: Plans FDA submission post-discussions; SOL-R data expected 1Q 2027.
Written By: Pharmacally Medical News Desk
Ocular Therapeutix announced positive topline results from the SOL-1 Phase 3 superiority trial of AXPAXLI (OTX-TKI), showing it outperformed aflibercept in maintaining vision for wet age-related macular degeneration (AMD) patients. This marks the first time a novel mechanism demonstrated superiority over an approved anti-VEGF in an FDA-aligned study.
“We are thrilled with SOL-1’s historic data positioning AXPAXLI as a major retina advance, delivering safe, durable vision/anatomic gains with far less treatment burden than aflibercept,” said Pravin U. Dugel, MD, Ocular Therapeutix’s Executive Chairman, President, and CEO. “Beating aflibercept’s stringent FDA bar in Phase 3 superiority where many fail with two-thirds rescue-free at Week 52 underscores axitinib’s potent pan-VEGF action in our reliable hydrogel.”
Trial Design and Primary Endpoint
Ocular report, SOL-1 (NCT06223958) enrolled 344 treatment-naïve wet AMD patients after an 8-week aflibercept loading phase, randomizing them 1:1 to a single 0.45 mg dose of AXPAXLI or 2 mg aflibercept.
The primary endpoint at Week 36 proportion maintaining vision (loss of <15 ETDRS letters from baseline) was met with 74.1% in the AXPAXLI arm versus 55.8% in aflibercept, yielding a 17.5% risk difference (p=0.0006).
The trial, under FDA Special Protocol Assessment, selected patients likely to lose vision post-loading, ensuring a rigorous test.
Key Secondary and Exploratory Results
At Week 52, 65.9% of AXPAXLI patients-maintained vision versus 44.2% on aflibercept (21.1% risk difference, p<0.0001). Rescue-free rates (no ≥15-letter loss or vision-threatening hemorrhage) favored AXPAXLI: 68.8% versus 47.7% at Week 52.
Fluid control was superior, with 55.9% of AXPAXLI subjects keeping central subfield thickness (CSFT) within 30 μm of baseline at Week 36 (versus 37.8%, p=0.0013 nominally). Using SOL-R criteria (>5-letter loss plus ≥75 μm CSFT increase), 77.1% were rescue-free at Week 24.
Endpoint | AXPAXLI |
| Aflibercept 2 mg | Risk Difference (p-value) |
Vision Maintenance Week 36 | 74.1% |
| 55.8% | 17.5% (0.0006) |
Vision Maintenance Week 52 | 65.9% |
| 44.2% | 21.1% (<0.0001) |
CSFT ≤30 μm Week 36 | 55.9% |
| 37.8% | 17.1% (0.0013) |
Rescue-Free Week 52 | 68.8% |
| 47.7% | 21.1% |
Safety Profile
AXPAXLI was well-tolerated through Week 52 (database lock February 5, 2026), with no treatment-related serious ocular or systemic adverse events, endophthalmitis, retinal vasculitis, detachment, or implant migration. Patients received re-dosing at Week 52 and will at Week 76, followed masked to Week 104.
Arshad M. Khanani, MD and Director of Clinical Research at Sierra Eye Associates in Reno, Nevada called it a major advance since anti-VEGF biologics debuted 20 years ago, praising fluid control and potential annual dosing.
Darius M. Moshfeghi, MD, Chief of the Retina Division at Byers Eye Institute of Stanford University School of Medicine, emphasized AXPAXLI’s unmatched durability and real-world benefits like handling missed visits.
Detailed SOL-1 data will present at the 49th Macula Society Meeting (February 25-28, 2026). Ocular plans an NDA submission post-FDA discussion; SOL-R non-inferiority topline expected 1Q 2027.
AXPAXLI (OTX-TKI) is a bioresorbable intravitreal hydrogel implant that continuously releases axitinib, a small-molecule multi-target tyrosine kinase inhibitor (TKI). Axitinib provides pan-VEGF suppression by blocking intracellular VEGF receptors (VEGFR1/2/3), complementing anti-VEGF biologics’ extracellular action for broad anti-angiogenic effects in wet AMD.
Wet AMD affects 1.7 million US patients, causing vision loss from VEGF-driven vessels; current injections lead to undertreatment. AXPAXLI, a hydrogel with axitinib TKI, could offer best-in-class durability if approved.
Reference
Ocular Therapeutix™ Reports Positive Results from Landmark SOL-1 Phase 3 Superiority Trial in Wet AMD, 17 February 2026, https://investors.ocutx.com/news-releases/news-release-details/ocular-therapeutixtm-reports-positive-results-landmark-sol-1
Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Ocular Therapeutix) (Axitinib Implant) in Subjects with Neovascular Age-Related Macular Degeneration, ClinicalTrials.gov ID NCT06223958, https://clinicaltrials.gov/study/NCT06223958
AXPAXLI Drug Profile, https://www.ocutx.com/pipeline/axpaxli/