Ocular Therapeutix (OCUL) Investor Day 2024 summary

Strategic transformation and vision

• Rapid transformation into a leading retinal company, anchored on robust clinical data, a de-risked regulatory pathway, and targeting large retinal vascular disease markets.

• Assembled a highly experienced retina team, including legacy and new experts, to drive innovation and advance clinical programs.

Clinical development and trial strategy

• SOL-1 is a pivotal, double-masked, randomized trial for AXPAXLI in wet AMD, designed under a Special Protocol Assessment (SPA) with the FDA, ensuring regulatory alignment and robust patient safety controls.

• Enrollment in SOL-1 has accelerated, with 151 subjects enrolled and 60 sites activated, attributed to strong site collaboration and an inclusive patient population.

• SOL-R, a phase III repeat dosing study, is designed for commercial impact, using a non-inferiority design versus EYLEA/aflibercept, enrolling both direct and SOL-1 failure patients.

Product profile and market opportunity

• AXPAXLI is a bioresorbable intravitreal implant delivering axitinib, a potent pan-VEGF tyrosine kinase inhibitor, with a duration of 9–12 months.

• Addresses unmet needs in wet AMD and NPDR, aiming to reduce treatment burden and improve long-term outcomes, with future expansion into PDR, DME, and retinal vein occlusion.

• The total US market potential for retinal vascular diseases is estimated at 9.2M patients, with diabetic retinopathy representing a large, underpenetrated segment.