Yatin Suneja

Yi Chen

Debanjana Chatterjee

Jennifer Kim

Tessa Romero

Yigal Nochomovitz

Colleen Kusy

Graig Suvannavejh

Greg Harrison

Kambiz Yazdi

Tyler Van Buren

Nick Quartapella

Yale Jen

Daniil Gataulin

Lisa Walter

Gregory Harrison

Greg Silvaniouve

Greg Silvanouve

- EyePoint Pharmaceuticals (EYPT) announced the initiation of its pivotal Phase 3 program for **DURAVYU** in Diabetic Macular Edema (DME), with first patient dosing anticipated in **Q1 2026**.  **[1314102_0001193125-25-239008_d14832dex991.htm:0]** 
- The DME program consists of two identical non-inferiority trials, "COMO" and "CAPRI," each designed to enroll approximately **240 patients** comparing DURAVYU 2.7mg (redosed every **six months**) against an on-label 2mg aflibercept control arm.  **[1314102_0001193125-25-239008_d14832dex991.htm:0]** 
- New preclinical data indicates that vorolanib, the active drug in DURAVYU, demonstrates a multi-mechanism of action by inhibiting both **VEGF-mediated vascular permeability** and **IL-6 mediated inflammation**.  **[1314102_0001193125-25-239008_d14832dex991.htm:0]** 
- The company reported over **$200 million** in cash as of **September 30, 2025**, providing a financial runway into **2027**, which extends beyond the anticipated **mid-2026** data readout for its fully enrolled Phase 3 wet AMD trials.  **[1314102_0001193125-25-239008_d14832dex992.htm:4]**

EyePoint Pharmaceuticals Initiates Phase 3 Program for DURAVYU in Diabetic Macular Edema

- EyePoint Pharmaceuticals has initiated its **Phase 3 pivotal trials for DURAVYU** (vorolanib intravitreal insert) for the treatment of **diabetic macular edema (DME)**, with first patient dosing anticipated in **Q1 2026**.  **[1314102_353312c0560449f18fb82b359b719e90_0]** **[1314102_353312c0560449f18fb82b359b719e90_1]** **[1314102_353312c0560449f18fb82b359b719e90_4]** 
- The Phase 3 program consists of two identical non-inferiority trials, "COMO" and "CAPRI," each enrolling approximately **240 patients** to compare DURAVYU 2.7mg against on-label 2mg aflibercept.  **[1314102_353312c0560449f18fb82b359b719e90_1]** 
- New preclinical data demonstrates that vorolanib, the active drug in DURAVYU, inhibits both **VEGF-mediated vascular permeability and IL-6 mediated inflammation**, positioning it as a potential multi-mechanism of action treatment for wet AMD and DME.  **[1314102_353312c0560449f18fb82b359b719e90_0]** **[1314102_353312c0560449f18fb82b359b719e90_1]** **[1314102_353312c0560449f18fb82b359b719e90_2]** **[1314102_353312c0560449f18fb82b359b719e90_3]** 
- DURAVYU is designed for **sustained drug delivery**, providing consistent daily dosing for at least **six months** after a single injection.  **[1314102_353312c0560449f18fb82b359b719e90_2]** **[1314102_353312c0560449f18fb82b359b719e90_3]**

EyePoint Announces Phase 3 Program for DURAVYU in DME

- EyePoint Pharmaceuticals anticipates reporting **Phase III data for DuraVu** (wet AMD) for the Lugano trial by **July/August 2026** and for the LUCHIA trial by the **end of Q3 2026**, with an expected launch in **2027**.  **[1314102_tx_379755_0]** **[1314102_tx_379755_5]** 
- DuraVu, a **Tyrosine Kinase Inhibitor (TKI)**, represents a new mechanism of action for wet AMD, and its safety profile has been **superb** with no ocular or systemic serious adverse events reported through Phase II and ongoing Phase III trials.  **[1314102_tx_379755_3]** **[1314102_tx_379755_4]** **[1314102_tx_379755_7]** 
- The company held a **positive end of Phase II meeting with the FDA in July** for its Diabetic Macular Edema (DME) program, with the first patient dosing expected in **2026**.  **[1314102_tx_379755_6]** 
- EyePoint ended Q2 with **$256 million in cash**, with guidance extending into **2027**, providing nine to twelve months of cash beyond the expected data readouts.  **[1314102_tx_379755_8]**

EyePoint Pharmaceuticals Provides Update on DuraVu Phase III Trials and Financial Position

- EyePoint Pharmaceuticals has **fully enrolled** both of its Phase 3 trials (Lugano and Lucia) for **DURAVYU™ (Verolanib)** in wet age-related macular degeneration (AMD), with top-line data expected for the Lugano trial in **mid-summer 2026** and the Lucia trial approximately **two months later** in 2026.  **[1314102_tx_379725_0]** **[1314102_tx_379725_2]** 
- The company aims for **non-inferiority** in visual acuity against aflibercept control (margin of **minus 4.5 letters**), continued safety, and a significant **reduction in treatment burden** (targeting at least 50%) to achieve commercial success.  **[1314102_tx_379725_3]** 
- EyePoint believes it is positioned to be the **first to file** among long-acting insert competitors, with a potential launch of DURAVYU™ by the **end of 2027** if approved.  **[1314102_tx_379725_6]** 
- Manufacturing capacity at its Northbridge, Massachusetts facility is projected to be close to **one million inserts a year**, sufficient to supply the global market.  **[1314102_tx_379725_7]** 
- A pivotal program for **DURAVYU™ in diabetic macular edema (DME)** is planned, with the first patient expected to be dosed sometime in **2026**, and current cash guidance extends **into 2027** (excluding DME trial costs).  **[1314102_tx_379725_10]**

EyePoint Pharmaceuticals Provides Update on Wet AMD Phase 3 Trials and Future Pipeline