A Phase 3 SOL-1 post hoc analysis suggests Ocular Therapeutix’s AXPAXLI could reduce wet AMD injection burden by up to 72% versus projected aflibercept dosing.
Written By: Anamika Koshti, PharmD
Reviewed By: Pharmacally Editorial Team
Ocular Therapeutix reported a new post hoc analysis from its Phase 3 SOL-1 trial as part of its second-quarter 2026 financial results and business update. The analysis estimates that AXPAXLI (also known as OTX-TKI), an investigational intravitreal axitinib hydrogel, could substantially reduce treatment burden for patients with wet AMD compared with a projected on-label aflibercept (2 mg) dosing schedule.
The update follows a positive Type C meeting with the US Food and Drug Administration (FDA) in May 2026, during which the agency confirmed that SOL-1, together with confirmatory evidence, may support an NDA submission under the 505(b)(2) regulatory pathway. The company plans to submit the NDA in the fourth quarter of 2026.
Post Hoc Analysis Estimates Lower Injection Burden
The exploratory post hoc analysis retrospectively applied the rescue criteria from the ongoing SOL-R trial to SOL-1 data to estimate the number of supplemental aflibercept injections patients would have required. The streamlined SOL-R rescue criteria, defined as a loss of more than five ETDRS letters together with at least a 75 µm increase in central subfield thickness (CSFT), were designed to better align rescue treatment decisions with real-world physician practice. Because the analysis was conducted after completion of the primary trial analyses, the findings should be considered exploratory.
Using these criteria, 66.5% of patients remained rescue-free through Week 52. Among the estimated 33.5% of patients requiring rescue therapy, the observed rescue rates translated to an average of 0.95 aflibercept rescue injections per patient following a single baseline AXPAXLI injection.
The treatment burden analysis began at Week -8, reflecting the screening and aflibercept loading period completed by all participants before randomization. From Week -8 through Week 52, the estimated mean number of injections excluding loading doses was 1.95 with AXPAXLI versus 7.0 with projected on-label aflibercept, representing an estimated 72% reduction in injection burden. Including loading doses, the estimated mean number of injections was 3.95 versus 9.0, corresponding to a 56% reduction.
AXPAXLI and SOL-1
AXPAXLI is an investigational, bioresorbable intravitreal hydrogel containing axitinib, a multi-target tyrosine kinase inhibitor with anti-angiogenic activity. The therapy is being developed for wet AMD and diabetic retinal diseases.
SOL-1 (NCT06223958) is a registrational Phase 3, multicenter, double-masked, randomized trial that enrolled 344 treatment-naïve patients across more than 100 sites in the United States and Argentina.
Earlier this year, SOL-1 met its primary endpoint, with 74.1% of AXPAXLI-treated patients maintaining vision at Week 36 compared with aflibercept (risk difference 17.5%; p=0.0006). The trial also achieved its key secondary endpoint at Week 52, with 65.9% of patients maintaining vision (risk difference 21.1%; p<0.0001).
AXPAXLI also demonstrated a favorable safety profile in SOL-1, with no treatment-related ocular serious adverse events (SAEs) reported. Peter K. Kaiser, MD, Chief Development Officer of Ocular Therapeutix, said the results suggest AXPAXLI may represent the first demonstrated superiority over an approved anti-VEGF therapy in a pivotal wet AMD study while substantially reducing treatment burden.
Regulatory Path Forward
The FDA has indicated that interim efficacy data from the ongoing SOL-R trial will not be required before NDA submission. Instead, the application is expected to include SOL-1 efficacy data, interim SOL-R safety findings, and confirmatory evidence, including extensive clinical experience with axitinib, which has been FDA-approved for renal cell carcinoma for more than a decade. Because axitinib is an approved active ingredient, the 505(b)(2) pathway may shorten the regulatory review timeline by approximately 60 days.
An interim SOL-R safety analysis expected in the fourth quarter of 2026 will expand the AXPAXLI safety database to more than 300 patients with at least one year of follow-up. Topline efficacy results from SOL-R are anticipated in the first quarter of 2028.
If approved, AXPAXLI could offer patients with wet AMD a longer-acting treatment option requiring substantially fewer intravitreal injections than current anti-VEGF therapy. Whether the modeled reduction in treatment burden translates into routine clinical practice will ultimately depend on regulatory review and post-approval real-world experience.
What This Means for Patients?
For patients with wet AMD, fewer required injections could directly address the adherence and under treatment problems limiting long-term outcomes with anti-VEGF therapy. If these post hoc findings hold through regulatory review and real-world use, a therapy averaging fewer than two injections through Week 52, versus seven with standard aflibercept dosing, could meaningfully ease the burden associated with current treatment for this largely elderly patient population.
Reference
Ocular Therapeutix™ Reports Second Quarter 2026 Financial Results and Business Highlights
About the Writer
Anamika Koshti (LinkedIn) is a PharmD professional and healthcare writer with interests in clinical research, pharmacovigilance, and evidence-based medicine. She has authored peer-reviewed publications on Alzheimer’s disease and PCOS, presented research at national conferences, and gained hands-on experience in medical content development and clinical data interpretation. She is committed to translating complex medical research into accurate, accessible content for healthcare professionals and patients.