OCULAR THERAPEUTIX, INC Q3 FY2025 earnings call

Pravin Dugel discussed that 2025 has been transformative for Ocular Therapeutix. They advanced 2 registrational studies in wet AMD (SOL-1 and SOL-R), with SOL-R reaching its target randomization of 555 subjects. They unveiled the HELIOS program in diabetic retinopathy, which aims for a broad superiority label covering the entire spectrum of diabetic retinal disease. AXPAXLI is designed for no surgery, no concomitant steroids, and familiar workflow for retina specialists. The SOL program is designed to generate comprehensive efficacy and safety data, and SOL-X long-term extension trial may provide long-term safety and evidence for early treatment. The HELIOS program uses an ordinal 2-step DRSS endpoint in diabetic retinopathy trials, which captures the full spectrum of patient responses and is aligned with FDA guidance.

SOL-1 remains on track for top line data in Q1 2026. SOL-R reached target randomization of 555 subjects and is progressing toward top line data in H1 2027. HELIOS program will initiate imminently. The company has financial strength to obtain top line data from SOL and HELIOS programs, pursue SOL-X, and prepare for commercialization.

Q: For the HELIOS-2 trial, how long to complete enrollment of 432 patients and enrollment difficulty for NPDR patients?

A: Don't expect issues in completing enrollment as there's great need and enthusiasm from patients and PIs. HELIOS-1 study showed overwhelming success, and the study is derisked with sustainable treatment potential.