WATERTOWN, Mass. - EyePoint Pharmaceuticals, Inc. (NASDAQ: NASDAQ:EYPT), a $587 million market cap biotechnology company, has announced the initiation of the LUCIA trial, the second global Phase 3 clinical trial for its investigational drug DURAVYU, intended for the treatment of wet age-related macular degeneration (wet AMD (NASDAQ:AMD)). The first patient in the trial has been dosed, marking a significant step in the company's efforts to address serious retinal diseases. The company's stock has seen significant volatility, currently trading 73% below its 52-week high of $30.99.
DURAVYU is a sustained delivery therapy that utilizes the proprietary Durasert E™ technology to deliver vorolanib, a selective tyrosine kinase inhibitor, directly into the eye. The LUCIA trial aims to establish the efficacy, safety, and dosing regimen of DURAVYU, with a focus on reducing the frequency of treatments required for wet AMD patients.
Wet AMD is a leading cause of vision loss in individuals over 50, characterized by the growth of abnormal blood vessels in the retina, which can leak fluid and cause severe vision impairment. Current treatments for wet AMD necessitate frequent intravitreal injections, which can lead to under-treatment and irreversible vision loss due to the high treatment burden.
The LUCIA trial, alongside the ongoing LUGANO trial, is part of a pivotal program that is unique in evaluating re-dosing every six months. The trials are double-masked, aflibercept controlled, and aim to enroll approximately 400 patients each. The primary endpoint is the average change in best corrected visual acuity at weeks 52 and 56 compared to baseline.
EyePoint's President and CEO, Jay S. Duker, M.D., expressed optimism about the enrollment rate and the potential of DURAVYU to offer valuable insights for real-world practice. The company is confident in its ability to rapidly enroll patients due to substantial global site commitments and the enthusiasm of patients and investigators. According to InvestingPro data, EyePoint maintains a strong liquidity position with a current ratio of 5.5 and holds more cash than debt on its balance sheet, though analysts note the company is currently burning through cash. For deeper insights into EyePoint's financial health and additional ProTips, investors can access the comprehensive Pro Research Report on InvestingPro.
The LUCIA trial includes both treatment-naïve and previously treated wet AMD patients and will assess the safety and secondary endpoints such as treatment burden reduction and anatomical results. DURAVYU is administered via a standard intravitreal injection, similar to existing FDA-approved anti-VEGF treatments.
EyePoint anticipates topline data from the Phase 3 pivotal trials in 2026 and from a Phase 2 trial in diabetic macular edema in the first quarter of 2025. The development of DURAVYU is part of the company's broader commitment to leveraging its sustained-release technology to improve treatment outcomes for retinal diseases. With five analysts recently revising their earnings estimates upward and price targets ranging from $18 to $68, InvestingPro subscribers can access detailed analyst consensus recommendations and comprehensive financial metrics to better evaluate the company's potential.
This report is based on a press release statement from EyePoint Pharmaceuticals, Inc. and does not include any additional analysis or commentary. The information presented is subject to the completion of ongoing clinical trials and regulatory review processes.
In other recent news, EyePoint Pharmaceuticals disclosed its third-quarter results, reporting a net revenue of $10.5 million and a net loss of $29.4 million. The company also initiated a public offering of its common stock valued at $100 million. These financial maneuvers are part of EyePoint's strategic efforts to extend its cash runway into 2027. In terms of research and development, EyePoint has made significant progress, including the release of positive interim data from the Phase 2 VERONA study in Diabetic Macular Edema (DME) and the commencement of dosing in the pivotal LUGANO study for wet Age-Related Macular Degeneration (AMD).
Analysts have reacted to these developments, with Baird maintaining an Outperform rating but reducing its price target to $33, and H.C. Wainwright maintaining a Buy recommendation but reducing its price target to $22. Guggenheim reiterated its Buy rating and $68.00 price target, while Laidlaw confirmed a Buy rating with a price target of $50.00. However, CapitalOne kept its Underweight rating.
EyePoint has also seen changes to its board with the appointment of Fred Hassan and the resignations of Anthony P. Adamis, M.D., and David Guyer, M.D. These recent developments reflect EyePoint's commitment to addressing serious retinal diseases through its ongoing clinical trials and potential FDA approval of Duravyu.
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