Biren Amin

Sean McCutcheon

Tazeen Ahmad

Yi Chen

Tara Bancroft

Colleen Hanley

Dingding Shi

Gregory Harrison

Jon Wolleben

Bill Maughan

Catherine

Colleen Kusy

Joe Thomas

Jonathan Wolleben

Kelly Shi

Lachlan Hanbury-Brown

Lisa Walter

Yuxi Dong

- OCULAR THERAPEUTIX is positioning its drug, **Ex Paxley**, to achieve the **first and only superiority label** versus an anti-VEGF for wet macular degeneration and nonproliferative diabetic retinopathy, backed by **FDA Special Protocol Agreements (SPA)** for its SOUL I and HELIOS II studies.  **[1393434_2162812_1]** 
- **Top-line data for the SOUL-one superiority trial in wet AMD is expected in 2026**, aiming to demonstrate **nine months of durability** for Ex Paxley, with data for twelve-month durability also being collected.  **[1393434_2162812_7]** 
- The company highlights a significant market opportunity, targeting the **$15 billion wet AMD market** and the unmet need in diabetic retinopathy, where current treatments face **high patient dropout rates (40%)** and **poor adherence (only 56% dosed to maximum label at one year)**.  **[1393434_2162812_2]** **[1393434_2162812_22]** **[1393434_2162812_23]** **[1393434_2162812_25]**

OCULAR THERAPEUTIX Outlines Strategy for Ex Paxley Superiority and Market Expansion

- Ocular Therapeutix highlighted its product **AXPAXLI**, a highly potent TKI designed for durability up to **12 months**, aiming for the **first superiority label** against anti-VEGFs in Wet AMD.  **[1393434_2163013:5]** 
- The company provided updates on its Wet AMD clinical program, including the **SOL-1 superiority trial**, with topline data expected in **1Q 2026**, and the **SOL-R non-inferiority study**, both conducted under Special Protocol Agreements (SPA) with the FDA.  **[1393434_2163013:5]** **[1393434_2163013:10]** **[1393434_2163013:13]** **[1393434_2163013:15]** 
- AXPAXLI is also being developed for Diabetic Retinopathy (DR) through the **HELIOS-2 and HELIOS-3 superiority trials**, which utilize a **novel ordinal DRSS primary endpoint** aligned with the FDA to unlock a significant market opportunity.  **[1393434_2163013:5]** **[1393434_2163013:48]** **[1393434_2163013:50]** 
- The company plans to submit the **AXPAXLI New Drug Application (NDA)** following the SOL-R 56-week topline data, combining results from both SOL-1 and SOL-R trials.  **[1393434_2163013:22]**

Ocular Therapeutix Details AXPAXLI Clinical Development and Market Strategy

- Ocular Therapeutix™ announced the pricing of an underwritten offering of **37,909,018 shares** of its common stock at **$12.53 per share**.  **[1393434_0001104659-25-094758_tm2527344d1_ex99-1.htm:0]** **[1393434_0001104659-25-094758_tm2527344d1_8k.htm:1]** 
- The offering is expected to generate **gross proceeds of approximately $475.0 million** and **net proceeds of approximately $445.9 million**.  **[1393434_0001104659-25-094758_tm2527344d1_ex99-1.htm:0]** **[1393434_0001104659-25-094758_tm2527344d1_8k.htm:1]** 
- The company plans to use the net proceeds to fund planned open-label extension and Phase 3 clinical trials for AXPAXLI, investments in infrastructure, pre-commercialization activities, and general corporate purposes.  **[1393434_0001104659-25-094758_tm2527344d1_ex99-1.htm:0]** 
- This capital, combined with existing cash and cash equivalents, is projected to fund the company's planned operating expenses, debt service obligations, and capital expenditure requirements **into 2028**.  **[1393434_0001104659-25-094758_tm2527344d1_8k.htm:2]**

Ocular Therapeutix Announces Pricing of Underwritten Common Stock Offering

- Ocular Therapeutix, Inc. announced updates on its AXPAXLI development programs for wet age-related macular degeneration (wet AMD) and non-proliferative diabetic retinopathy (NPDR).  **[1393434_0001104659-25-094724_tm2527344d2_8k.htm:1]** 
- For wet AMD, the **SOL-1 Phase 3 trial** completed randomization in **December 2024**, with topline results anticipated in **Q1 2026**.  **[1393434_0001104659-25-094724_tm2527344d2_8k.htm:1]**  The **SOL-R Phase 3 trial** has completed enrollment, with topline results expected in **H1 2027**.  **[1393434_0001104659-25-094724_tm2527344d2_8k.htm:2]** 
- For NPDR, the company plans to initiate Phase 3 clinical trials, HELIOS-2 and HELIOS-3. The **FDA provided written agreement** on the overall design of the **HELIOS-2 trial** in **August 2025**.  **[1393434_0001104659-25-094724_tm2527344d2_8k.htm:3]** 
- In **September 2025**, the company received a **notice of allowance** for a patent application covering methods of treating ocular diseases with AXPAXLI, with the resulting patent expected to expire in **2044**.  **[1393434_0001104659-25-094724_tm2527344d2_8k.htm:3]**

Ocular Therapeutix, Inc. Provides Updates on AXPAXLI Clinical Programs and Patent Allowance

- Ocular Therapeutix highlighted progress in its **SOL wet AMD registrational program** for AXPAXLI™, with **topline data for SOL-1 expected in 1Q 2026** and **SOL-R topline data in 1H 2027**.  **[1393434_777e8bace23a4105860ecafcd621d75a_0]** **[1393434_777e8bace23a4105860ecafcd621d75a_1]** **[1393434_777e8bace23a4105860ecafcd621d75a_2]** 
- The company announced plans to initiate two new **Phase 3 superiority registrational trials (HELIOS-2 and HELIOS-3)** for AXPAXLI™ in **non-proliferative diabetic retinopathy (NPDR)**, aiming to evaluate 6- and 12-month dosing intervals.  **[1393434_777e8bace23a4105860ecafcd621d75a_0]** **[1393434_777e8bace23a4105860ecafcd621d75a_4]** 
- These NPDR trials will utilize a **novel ordinal ≥2-step diabetic retinopathy severity score (DRSS) primary endpoint**, which has received FDA alignment through a Special Protocol Assessment (SPA) agreement for HELIOS-2.  **[1393434_777e8bace23a4105860ecafcd621d75a_0]** **[1393434_777e8bace23a4105860ecafcd621d75a_5]**

Ocular Therapeutix Provides Updates on AXPAXLI Clinical Programs and Future Plans

OCULAR THERAPEUTIX (OCUL)