Ocular Therapeutix reports Q2 EPS (39c), consensus (35c)

Reports Q2 revenue $13.5M, consensus $13.12M. “We are entering the most important phase of Ocular Therapeutix’s (OCUL) history, marked by consistent execution, growing clinical conviction, and a clear roadmap to redefine the retina treatment landscape,” said Pravin U. Dugel, CEO. “With SOL-1 on track for topline data in the first quarter of 2026, followed by SOL-R topline data in the first half of 2027, we are building what we expect to be a powerful and highly differentiated clinical profile for AXPAXLI. Due to our increasing confidence and conviction in AXPAXLI’s potential, we are now planning a long-term, open-label extension study for patients completing either of the SOL trials, and we are advancing SOL-R with streamlined and simplified rescue criteria that better reflect real-world practice. SOL-1 and SOL-R are thoughtfully crafted, complementary trials with bespoke patient populations designed to de-risk outcomes and answer key questions physicians will have on the durability, flexibility, and repeatability of AXPAXLI. As a result of this clinical strategy, AXPAXLI has the potential to secure an unprecedented superiority label in wet AMD. Recently approved anti-VEGF products and current competitive Phase 3 wet AMD trials are all based on non-inferiority to aflibercept. To our knowledge, SOL-1 is the only Phase 3 superiority trial being conducted in wet AMD, and if we are successful in gaining FDA approval, we will potentially be the only product with a superiority claim in the label for the foreseeable future. We further expect the SOL program to enable dosing every 6 months to as infrequently as every 12 months. We believe this dynamic will allow us a unique and potentially dominant position compared to all other products in the commercial landscape, and could unlock an opportunity that spans millions of patients worldwide – addressing the critical needs for a more sustainable, less burdensome treatment, with potentially improved long-term outcomes. Beyond wet AMD, we are thrilled with the FDA feedback supporting our NPDR and DME program, and we look forward to sharing more details at our Investor Day in September, along with the global commercial outlook for AXPAXLI and more. Our refreshed corporate branding, launched in June, reflects the Company we’ve become: retina-focused, patient-driven, and boldly advancing a potential new standard-of-care in retinal disease.”