Ocular Therapeutix Maps Regulatory Strategy For Lead Drug Program
I'm LongbridgeAI, I can summarize articles.Ocular Therapeutix outlined its regulatory strategy for lead drug AXPAXLI, aligning with the FDA to submit an NDA for wet AMD in Q4 2026 based on SOL-1 trial data. The company revised the SOL-R study design to focus on long-term differentiation rather than efficacy for the NDA, pushing top-line data to Q1 2028. Additionally, Ocular consolidated its diabetic retinopathy program around the HELIOS-3 registrational study.
Ocular Therapeutix, Inc. (NASDAQ:OCUL) stock is trading higher on Wednesday as the company prepares for its Investor Day, where it will detail its plans for submitting a New Drug Application (NDA) for AXPAXLI.
The stock’s decline comes amid a mixed market backdrop, with S&P 500 futures showing a slight gain of 0.1%.
OCUL Investor Day: AXPAXLI NDA Submission Plan And FDA Alignment
The eye-focused biotech plans to submit an NDA for AXPAXLI in wet age-related macular degeneration (AMD) during the fourth quarter of 2026 after reaching alignment with the U.S. Food and Drug Administration (FDA) on a filing strategy centered on data from the SOL-1 trial.
The company noted that the planned submission will rely on SOL-1 efficacy and safety results, together with interim safety data from the ongoing SOL-R study.
Ocular said SOL-R efficacy data will no longer be included in the NDA package.
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FDA Supports Single-Trial Filing Strategy
Ocular said the agency indicated it would review the application based on the SOL-1 study, which previously met its primary endpoint with a p-value of 0.0006.
SOL-1 demonstrated superiority on the primary endpoint of vision maintenance at Week 36 and showed supportive anatomical outcomes.
Ocular added that all six pre-specified sensitivity analyses for the primary endpoint achieved statistical significance, while the first three key secondary endpoints also met significance thresholds.
The company plans to support the filing with additional confirmatory evidence.
SOL-R Study Modified To Support Long-Term Differentiation
With SOL-R no longer required to provide efficacy data for the NDA, Ocular said it will extend masking through Week 96 and add secondary endpoints aimed at further differentiating AXPAXLI from aflibercept therapies.
The revised study will evaluate superiority versus Regeneron Pharmaceutical Inc.‘s (NASDAQ:REGN) Eylea (aflibercept) 8 mg in best corrected visual acuity at Week 96. Ocular also plans to assess the prevention of fibrosis and atrophy compared with aflibercept 2 mg.
As a result of the redesign, topline SOL-R data are now expected in the first quarter of 2028.
The study’s primary endpoint of non-inferiority in visual acuity change at Week 56 remains unchanged.
Diabetic Retinopathy Program Consolidated Around HELIOS-3
Ocular also announced plans to streamline its diabetic retinopathy development program by prioritizing HELIOS-3 as a single global registrational superiority study.
The Phase 3 trial will evaluate once-yearly AXPAXLI dosing against sham treatment in patients with non-proliferative diabetic retinopathy.
OCUL Stock Price Activity: Ocular Therapeutix shares were trading 6.49% higher at $9.52 at the time of publication on Wednesday, according to Benzinga Pro data.
Image by New Africa via Shutterstock
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