Ocular Therapeutix, Inc. (OCUL) Q3 2025 Earnings Call

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WEBVTT 00:00:00.031 -- 00:00:05.098 We believe the strategy allows us to capture the full spectrum 00:00:05.098 -- 00:00:10.523 of diabetic eye disease with a single registrational program. 00:00:10.625 -- 00:00:14.270 The unmet need here is staggering. 00:00:14.270 -- 00:00:19.417 Diabetic eye disease affects more than 100 million people globally, yet the 00:00:19.417 -- 00:00:22.940 majority remain undertreated. 00:00:23.243 -- 00:00:28.456 Even among NPDR patients without DME, Disease progression 00:00:28.456 -- 00:00:33.543 leads to irreversible vision loss if left unmanaged. 00:00:33.543 -- 00:00:39.290 Current treatment paradigms are largely reactive, waiting until vision-threatening 00:00:39.290 -- 00:00:42.935 complications occur prior to intervention. 00:00:42.935 -- 00:00:47.000 We believe that must change. 00:00:47.000 -- 00:00:52.948 Our Helios 2 and Helios 3 Phase 3 trials are designed as superiority 00:00:52.948 -- 00:00:58.262 studies to demonstrate that early infrequent treatment with Expaxly 00:00:58.262 -- 00:01:02.165 can meaningfully alter the course of disease. 00:01:02.165 -- 00:01:07.730 Helios 2 is being conducted under a SPA agreement with the FDA, underscoring 00:01:07.730 -- 00:01:14.156 our continued commitment to regulatory alignment and scientific rigor. 00:01:14.156 -- 00:01:19.401 Together, these two trials will evaluate 6- and 12-month dosing intervals, 00:01:19.401 -- 00:01:25.165 providing flexibility to address diverse patient needs. 00:01:25.199 -- 00:01:30.627 A key innovation in these studies is our primary endpoint, an ordinal 00:01:30.627 -- 00:01:35.354 two-step DRSS endpoint at week 52. 00:01:35.354 -- 00:01:36.757 Historically, 00:01:36.757 -- 00:01:41.864 phase 3 DR trials have relied on binary diabetic retinopathy 00:01:4...