Ocular Therapeutix told investors on June 17, 2026 that the FDA has agreed to look at its wet AMD drug AXPAXLI on the strength of a single pivotal trial. The company plans to file its New Drug Application in the fourth quarter of 2026. It scheduled an Investor Day in New York for 2:00 PM ET that day, with virtual access, to lay out the plan.
The deal was struck at a Type C meeting with the agency in May 2026. The filing will rest on Week 52 efficacy and safety results from the SOL-1 trial, plus interim safety data from a second study, SOL-R.
Why SOL-R still matters
The FDA wants safety exposure in at least 300 patients. SOL-1 gave 170 people AXPAXLI, so Ocular will run an interim safety analysis of SOL-R patients who complete a year of treatment, pushing the total past 300. That analysis carries a cost: a 0.0001 alpha penalty on SOL-R’s later statistical work.
SOL-R’s efficacy data will not go into the application. The company is changing the trial instead. It will stay masked through Week 96, and a new key secondary endpoint will test whether AXPAXLI beats aflibercept (8 mg) on mean change in best corrected visual acuity. Ocular also wants to look for prevention of fibrosis and atrophy against aflibercept (2 mg), which could earn a line on the label. Topline results have moved to the first quarter of 2028.
Ocular says it will file under the 505(b)(2) pathway. The company puts the possible time savings at up to 60 days of review. A pre-NDA meeting is planned for the third quarter of 2026, and Year 2 safety data from SOL-1 would follow at the standard 120-day safety update.
What SOL-1 showed
The company reported SOL-1 topline results in February 2026. At Week 36, 74.1 percent of patients on AXPAXLI (0.45 mg) had maintained vision, a 17.5 percent risk difference against aflibercept (2 mg), with a p-value of 0.0006. At Week 52 the figure was 65.9 percent, a 21.1 percent difference. The trial randomized 344 treatment-naive patients.
“The strength of the SOL-1 data speaks for itself,” said Pravin U. Dugel, the company’s executive chairman, president and CEO. He said Ocular is “well positioned to bring AXPAXLI to patients in 2027, if approved.”
Dr. Lejla Vajzovic of Duke University School of Medicine put the clinical argument plainly. More than 40 percent of wet AMD patients stop treatment or fall off schedule within the first year, she said, because the burden can be too much. “Missed visits mean lost vision.”
The diabetic retinopathy program is being narrowed too. HELIOS-3, testing AXPAXLI given every 12 months against sham, becomes the single registrational trial. Dugel said the company’s market research shows retina specialists strongly favor a once-yearly regimen.
Sources
- Ocular Therapeutix Investor Day to Highlight U.S. FDA Alignment on AXPAXLI NDA with Submission Planned for Fourth Quarter 2026
- Ocular Therapeutix™ Investor Day to Highlight U.S. FDA Alignment on AXPAXLI™ NDA with Submission Planned for Fourth Quarter 2026
