Ocular Therapeutix, Inc.

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 statistical powering, allowing more efficient studies with a smaller sample size. It potentially provides a higher probability of success compared to other endpoints considered. And it aligns fully with FDA guidance, as confirmed in our SPA for Helios 2. We evaluated other endpoints, such as vision-threatening complications or VTCs, but those present major limitations. VTCs are binary and event-driven, which require much larger sample sizes and longer durations to reach statistical power. They also reflect late-stage disease progression rather than early therapeutic benefit. In short, ordinal DRSS is not only more clinically relevant with a potentially higher probability of success, but it is also agreed to with the FDA from a regulatory standpoint. It's the right endpoint to demonstrate Xpaxley's disease-modifying potential in DR. Since announcing this endpoint at our investor day, the feedback from both investigators and the broader retina community has been outstanding. We believe this approach represents the future of diabetic retinopathy trial design, and we expect this ordinal endpoint will become the new gold standard for the field moving forward. Unlike our wet AMD program, The Helios 3 trial employs sham injections, and there are important regulatory reasons for that distinction. DR trials have very different regulatory requirements compared to the 2023 FDA draft guidance for wet AMD. Sham should not be used in wet AMD or even in central involving DME studies because they require subjective visual acuity primary endpoints where sham injections may not provide adequate masking and could influence outcomes. In DR, however, outcomes are based on objective retinal photographs, not subjective patient responses. Moreover, since there is no universal standard of care for NPDR, sham control is not only acceptable, but necessary to ensure global regulatory alignment particularly in countries without approved therapies for this population. Finally, our design strategy enables us to pursue a single unified DR label that encompasses both NPDR and DME. Because DME is a complication affecting a subset of DR patients, all patients with DME inherently have underlying retinopathy, In Helios 2 and Helios 3, we plan to include patients with non-center-involved DME. Subjects with non-center-involved DME demonstrated improvement with Expaxly in our Helios Phase 1 study. We believe this approach eliminates the need for separate DME trials and may position us to address the full diabetic eye disease spectrum with a single registrational program. By focusing on a superiority-driven DR label that captures the entire continuum of disease, we believe Xpaxly can unlock a market opportunity that is not just incremental, but transformative for patients, physicians, and payers worldwide. We ended the third quarter of 2025 with approximately $345 million which does not reflect approximately $445 million in net proceeds from our October equity financing. We were thrilled to see the enthusiasm for participation in our recent financing, validating the bold, opportunistic decisions we have made to date. Every decision that is made in this company is made from a position of confidence. in our drug, expaxily, and in our clinical strategy and in our market potential. Our confidence is compounded by consistently positive feedback we are hearing externally, including from payers who represent the vast majority of covered lines in the U.S. These discussions have reinforced the excitement we have seen from investors and further validated our triad-based strategy. These perspectives underscore that the market is already preparing for a future potentially defined by Xpaxly, one where potentially better outcomes, lower burden, and cost efficiency converge. Following our recent financing, we are now in an enviable position with an expected cash runway into 2028 and the financial flexibility for top-line data from both Sol and Helios registrational programs, advance Solex, our long-term extension trial, invest in manufacturing capacity and infrastructure, and prepare for commercial launch and global expansion in anticipation of a potential expatsily approval. We are operating from a position of increased strength. Every capital decision we make is proactive, not reactive, made from conviction, not constraint.

When you put it all together, our science, our trial design, our execution, and our strategic vision,

The path forward is clear. We are building ocular therapeutics around the triad that defines how we intend to redefine the retina experience. Potential superiority label, setting a new standard of durability that transcends incremental improvements, creating lasting competitive differentiation and potential insulation from pricing and step therapy pressures. Market expansion, transforming a $15 billion treated market into a much larger addressable opportunity by reducing burden, improving adherence, and reaching millions of untreated patients with wet AMD and DR. Immediate adaptability, delivering a product that fits seamlessly into existing practice.