“The strength of the SOL-1 data speaks for itself,” Pravin U. Dugel, chief executive of Ocular Therapeutix, said as the company opened its Investor Day on June 17. He called SOL-1 “the first successful trial in wet AMD for a novel agent showing superiority over an approved anti-VEGF.”
The event began at 2:00 p.m. ET in New York City, with virtual access, and it came with news. Ocular said the FDA has aligned with its plan to submit a New Drug Application for AXPAXLI, also known as OTX-TKI, in the fourth quarter of 2026. Per a Type C meeting in May 2026, the application will be based on SOL-1 Week 52 efficacy and safety data plus interim safety data from SOL-R, a second trial.
The company will run that interim SOL-R analysis in the fourth quarter to reach more than 300 patients of safety data across both studies, in line with FDA requirements. SOL-R efficacy data are out of the filing. Ocular will file under the 505(b)(2) pathway, which it says could speed the review by up to 60 days.
What SOL-R does now
With the efficacy case resting on SOL-1, the company is redesigning SOL-R. It will stay masked through Week 96, and topline results are now expected in the first quarter of 2028. A new key secondary endpoint will ask whether AXPAXLI is superior to aflibercept 8 mg in mean change in best corrected visual acuity at that point.
Dugel said the company also hopes to show AXPAXLI prevents fibrosis and atrophy compared with aflibercept 2 mg at Week 96. The aim, he said, is to make AXPAXLI “the best-in-disease agent for wet AMD.” The company said the added endpoint could help establish that position and set the drug’s label apart, if approved.
Dugel said Ocular is “well positioned to bring AXPAXLI to patients in 2027, if approved.”
Diabetic retinopathy gets a single trial
After strong SOL-1 results, Ocular is trimming its diabetic retinopathy program to one Phase 3 study, HELIOS-3. It would be a single global registrational trial of once-yearly AXPAXLI against sham in non-proliferative diabetic retinopathy. Dugel pointed to up to 12 months of durability seen in SOL-1 and in an earlier trial, HELIOS-1, as the basis for the decision, and said the company’s market research shows retina specialists strongly favor a once-yearly regimen for rapid uptake.
AXPAXLI is an investigational bioresorbable intravitreal hydrogel that incorporates axitinib, a tyrosine kinase inhibitor with anti-angiogenic properties. A pre-NDA meeting with the FDA is set for the third quarter of 2026 to confirm what the submission should contain.
Sources
- Ocular Therapeutix™ Investor Day to Highlight U.S. FDA Alignment on AXPAXLI™ NDA with Submission Planned for Fourth Quarter 2026
- FDA Alignment Boosts Wet AMD Treatment Path
