Ocular Therapeutix aligns with FDA on AXPAXLI NDA submission for wet AMD, targeting Q4 2026 filing with Phase 3 SOL-1 data and long-term safety from SOL-R.
Written By: Nalam Karthik, PharmD
Reviewed By: Pharmacally Editorial Team
Ocular Therapeutix has secured FDA alignment on its regulatory pathway for AXPAXLI (OTX-TKI), an investigational axitinib-based intravitreal hydrogel for wet age-related macular degeneration (AMD). The company plans to submit a New Drug Application (NDA) in the fourth quarter of 2026 using data from the Phase 3 SOL-1 trial, supported by interim safety data from the ongoing SOL-R study.
The FDA indicated that SOL-1 could serve as the primary efficacy study for review, while additional safety exposure from SOL-R would help satisfy regulatory requirements. Ocular intends to submit the application through the 505(b)(2) pathway, which may shorten the review timeline compared with a traditional NDA.
Scientific and Clinical Context
Wet AMD is a leading cause of irreversible vision loss worldwide. Current anti-VEGF therapies can preserve vision, but frequent intravitreal injections create a substantial treatment burden that contributes to poor adherence and disease progression.
AXPAXLI is a bioresorbable hydrogel implant that delivers axitinib, a multi-target tyrosine kinase inhibitor with anti-angiogenic activity. The therapy aims to provide prolonged VEGF suppression and reduce the need for repeated injections.
Phase 3 Data Support Regulatory Strategy
The registrational Phase 3 SOL-1 trial (NCT06223958) enrolled 344 treatment-naïve patients with wet AMD and evaluated a single 0.45 mg dose of AXPAXLI against aflibercept 2 mg.
The study met its primary endpoint at Week 36. A total of 74.1% of patients receiving AXPAXLI maintained vision, producing a 17.5% treatment difference versus aflibercept (p=0.0006). A key secondary endpoint was also achieved at Week 52, with 65.9% of AXPAXLI-treated patients maintaining vision compared with the control arm, corresponding to a 21.1% treatment difference (p<0.0001).
The trial demonstrated durable disease control through one year and reported a favorable safety profile. Ocular plans an interim SOL-R safety analysis in late 2026 to exceed the FDA’s requirement of more than 300 patients with at least one year of treatment exposure.
Strategic Changes to SOL-R and Diabetic Retinopathy Program
Because SOL-R efficacy data will no longer be required for the NDA submission, Ocular has modified the trial to focus on long-term differentiation. The study will remain masked through Week 96, with a new key secondary endpoint evaluating superiority in best-corrected visual acuity versus aflibercept 8 mg. Top-line SOL-R results are now expected in the first quarter of 2028.
The company also streamlined its diabetic retinopathy development strategy. Rather than pursuing multiple registrational studies, Ocular will prioritize the Phase 3 HELIOS-3 trial, which is evaluating once-yearly AXPAXLI dosing in patients with non-proliferative diabetic retinopathy.
Path Toward Approval
Ocular expects to hold a pre-NDA meeting with the FDA in the third quarter of 2026 and submit a complete NDA package later that year. If approved, AXPAXLI could become one of the first long-acting retinal therapies offering year-long disease control, potentially reducing treatment burden for patients with wet AMD while expanding options for retinal specialists.
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About the Writer
Nalam Karthik (LinkedIn) is a healthcare writer and PharmD graduate with interests in pharmacovigilance, drug safety, clinical data analysis, and quality assurance. He is passionate about translating clinical and pharmaceutical knowledge into accessible healthcare content while staying engaged with advancements in drug development and patient safety initiatives.