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Investing.com -- Shares of EyePoint Pharmaceuticals, Inc. (NASDAQ: NASDAQ:EYPT) tumbled 21% following the release of positive clinical trial results for their DURAVYU™ treatment, confounding analysts who viewed the data as promising. The Phase 2 VERONA trial, focused on treating diabetic macular edema (DME), met its primary endpoint and showed significant improvements in visual acuity and anatomical control without serious adverse events.
The trial results indicated that both tested doses of DURAVYU™ successfully extended the time to first supplemental injection compared to the aflibercept control. The 2.7mg dose of DURAVYU™ achieved a 73% supplement-free rate up to week 24, significantly higher than the 50% rate for aflibercept-treated eyes. Additionally, the DURAVYU™ treatment demonstrated a +7.1 letter gain in best corrected visual acuity (BCVA) and a 76-micron reduction in central subfield thickness (CST), suggesting a strong potential for the treatment in the DME market.
Despite these positive outcomes, EyePoint’s stock experienced a sharp decline. Cantor Fitzgerald analyst Jennifer Kim commented on the market reaction, stating, "There’s nothing here that makes us less positive on the DME data/opportunity - if anything, it gives us higher confidence in the PoS for a less clinically risky non-inferiority pivotal program." Kim’s remark underlines the disconnect between the trial’s success and the stock’s performance.
The selloff appears to be a reaction to the lack of details on the performance of the aflibercept control arm and the decision to proceed with a non-inferiority pivotal program, which some investors may have interpreted as a conservative approach. Kim also noted that the market’s response was overdone, especially considering the stock’s rally to approximately $12 following preliminary data from the same trial in October 2024.
EyePoint’s management plans to engage with the FDA in the second quarter regarding the initiation of a Phase 3 clinical trial for DURAVYU™, with the aim of establishing it as a best-in-class treatment for DME. The company’s positive safety profile and efficacy data across multiple Phase 2 clinical trials position DURAVYU™ as a potential blockbuster in the treatment of serious retinal diseases.
Investors and analysts will be closely monitoring additional details from the company, particularly concerning the aflibercept control arm and the robustness of the Week 24 BCVA and CST averages. The upcoming medical meetings where the 16-week interim data and six-month results will be presented are anticipated to provide further insights into the treatment’s potential and its impact on EyePoint’s market valuation.
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