Ocular Therapeutix (NasdaqGM:OCUL) 2025 Earnings Call Presentation

AXPAXLI's Clinical Development and Regulatory Strategy - Ocular Therapeutix is targeting the FIRST SUPERIORITY LABEL vs anti-VEGFs for AXPAXLI [26, 29, 32, 35, 38] - AXPAXLI has SPA Agreements for SOL-1 & HELIOS-2 Trials, supporting a regulatory path for a superiority label [36] - SOL-1 is designed for success with FDA alignment through SPA, randomization of strong anti-VEGF responders, and the potential for a superiority claim on the label [133, 134, 136, 137, 140, 141, 152, 153] - SOL-R is designed for seamless, immediate adoption with methodical patient selection to exclude subjects with early persistent fluid [93, 94, 95, 96, 97, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 191, 192, 193, 194, 195, 196, 197, 198, 199, 233, 234, 235, 236, 237] - The company plans for AXPAXLI NDA submission following SOL-R 56-Week Topline Data, with a package expected to exceed the requirements for FDA's safety database [230, 231, 232] AXPAXLI's Commercial Potential and Market Opportunity - The 2024 Global Branded Anti-VEGF Revenue is $15 Billion, indicating a significant market size [49, 52, 55] - AXPAXLI has the opportunity to significantly expand the $15B Global Retina Market by redefining the treatment attrition curve in wet AMD and establishing a standard of care in NPDR [57, 58, 59, 60, 82, 83, 84, 85, 86, 87, 88, 89, 90] - There are 18 million people with wet AMD in the U S, with 40% discontinuing treatment in the first year, presenting an opportunity for AXPAXLI to improve adherence [57, 59, 83, 86] - There are 64 million people with NPDR in the U S, with less than 1% of patients currently treated, indicating a large undertreated population [86, 89] Expansion into Diabetic Retinopathy - The company is targeting a broad indication in Diabetic Retinopathy, aiming to treat the full spectrum of diabetic retinal disease, including patients with or without DME [418, 419, 420, 421, 422, 423, 424, 425, 426, 427, 428, 429, 431, 432, 433, 434, 435, 436, 437, 438, 439, 440] - The HELIOS-1 study showed a 231% 2-step DRSS improvement in the AXPAXLI arm at Week 48 compared to 0% in the sham arm [397, 398, 399]