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

Investor webinar replay

Replay transcript excerpt

We believe the strategy allows us to capture the full spectrum of diabetic eye disease with a single registrational program. The unmet need here is staggering. Diabetic eye disease affects more than 100 million people globally, yet the majority remain undertreated. Even among NPDR patients without DME, Disease progression leads to irreversible vision loss if left unmanaged. Current treatment paradigms are largely reactive, waiting until vision-threatening complications occur prior to intervention. We believe that must change. Our Helios 2 and Helios 3 Phase 3 trials are designed as superiority studies to demonstrate that early infrequent treatment with Expaxly can meaningfully alter the course of disease. Helios 2 is being conducted under a SPA agreement with the FDA, underscoring our continued commitment to regulatory alignment and scientific rigor. Together, these two trials will evaluate 6- and 12-month dosing intervals, providing flexibility to address diverse patient needs. A key innovation in these studies is our primary endpoint, an ordinal two-step DRSS endpoint at week 52. Historically, phase 3 DR trials have relied on binary diabetic retinopathy severity score, or DRSS, endpoints, counting only the percentage of patients who achieve a greater than or equal to two-step improvement or those who achieve a greater than set worsening not both while straightforward this method discards valuable clinically relevant data our ordinal analysis by contrast captures the entire spectrum of patient responses improvement stability and worsening allowing every participant to contribute data to the statistical analysis this approach offers several distinct advantages. It reflects real-world treatment goals to both improve disease and prevent worsening. It increases statisti...