DURAVYU shows promise in Phase 2 trial for eye disease

WATERTOWN, Mass. - EyePoint Pharmaceuticals, Inc. (NASDAQ: NASDAQ:EYPT), currently valued at $535 million, announced positive results from the Phase 2 VERONA clinical trial of DURAVYU™, its investigational treatment for diabetic macular edema (DME). The trial met its primary endpoint by extending the time to the first supplemental injection compared to the aflibercept control for both tested doses of DURAVYU. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 5.5x, though it’s currently experiencing significant cash burn as it advances its clinical programs.

The 2.7mg dose of DURAVYU demonstrated a significant early and sustained improvement in best corrected visual acuity (BCVA), with a gain of +7.1 letters at week 24. Additionally, a reduction of 76 microns in central subfield thickness (CST) was observed, indicating a notable anatomical improvement. Importantly, 73% of patients treated with the 2.7mg dose were supplement-free up to week 24, which is a higher rate compared to the 50% in the aflibercept control arm. These promising results have caught analysts’ attention, with InvestingPro showing five analysts recently revising their earnings estimates upward, with price targets ranging from $18 to $68 per share.

The safety profile of DURAVYU continued to be favorable, with no related ocular or systemic serious adverse events (SAEs) reported. The promising results from the VERONA trial, which enrolled 27 patients, add to the growing body of evidence supporting the potential of DURAVYU as a treatment for serious retinal diseases.

EyePoint Pharmaceuticals plans to engage with the FDA in the second quarter to discuss the initiation of a Phase 3 clinical trial later in 2025. This follows the positive efficacy and safety data across multiple Phase 2 clinical trials, positioning DURAVYU as a potential treatment option for patients with DME, a leading cause of vision loss in working-age adults.

DME is a significant public health concern, with the number of diabetic retinopathy patients expected to reach 16 million by 2050. The current standard of care often requires frequent injections, posing a burden on patients and healthcare systems. DURAVYU aims to offer a more durable treatment option, potentially improving patient compliance and outcomes. While the company reported revenue of $45.7 million in the last twelve months, InvestingPro analysis reveals over 10 key financial insights and metrics that could impact the company’s market position. Subscribers can access the comprehensive Pro Research Report, which provides detailed analysis of EyePoint’s financial health and growth prospects.

DURAVYU utilizes EyePoint’s proprietary Durasert E™ technology to deliver vorolanib, a selective tyrosine kinase inhibitor, as a solid bioerodible insert. The treatment aims to block VEGF receptors for at least six months, enabling extended dosing intervals.

The information reported is based on a press release statement from EyePoint Pharmaceuticals. The company is actively enrolling in two ongoing global Phase 3 clinical trials for wet age-related macular degeneration (wet AMD (NASDAQ:AMD)), with topline data expected in 2026. DURAVYU is also being investigated for DME, with a Phase 3 pivotal program anticipated to start by the end of 2025.

In other recent news, EyePoint Pharmaceuticals has made significant strides in the clinical development of its lead product candidate, DURAVYU™, for the treatment of wet age-related macular degeneration (AMD). The company’s Phase 3 LUGANO and LUCIA trials are progressing well, with the LUGANO trial already one-third enrolled and the LUCIA trial advancing ahead of schedule. EyePoint also anticipates the release of full data from the Phase 2 VERONA clinical trial for diabetic macular edema (DME) within the first quarter of 2025.

EyePoint has also appointed Dr. Reginald J. Sanders, a renowned retina specialist, to its Board of Directors. Analysts from Citi have initiated a Buy rating on EyePoint, highlighting the company’s promising prospects in the wet AMD treatment space. Baird, on the other hand, has maintained its Outperform rating on EyePoint’s shares, expressing a bullish stance on the potential of EyePoint’s wet AMD treatments and considering the DME data as an additional positive factor.

The company holds a robust financial position, with an estimated $370 million in cash and investments as of December 31, 2024, and a cash runway extending into 2027. These developments are part of EyePoint’s broader commitment to leveraging its sustained-release technology to improve treatment outcomes for retinal diseases.

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