WATERTOWN, Mass. - EyePoint Pharmaceuticals, Inc. (NASDAQ: NASDAQ:EYPT) today announced interim results from its Phase 2 VERONA clinical trial for DURAVYU, a treatment for diabetic macular edema (DME). The data indicates a significant improvement in visual acuity and retinal thickness for patients.
The trial, which evaluated the efficacy of DURAVYU, a sustained delivery therapy, showed an early and continued increase in best-corrected visual acuity (BCVA) by 8.9 letters from baseline, surpassing the 3.2 letters improvement seen with the aflibercept control. Additionally, there was a 68.1-micron reduction in central subfield thickness (CST), compared to 30.5 microns with aflibercept.
President and CEO of EyePoint, Dr. Jay S. Duker, expressed optimism about the interim results, highlighting the early and maintained improvement in BCVA and CST. He emphasized the need for more durable treatments for DME, a prevalent disease with significant impact on vision.
The safety profile of DURAVYU was also noted to be favorable, with no serious adverse events related to the treatment observed. The trial reported that 82% of eyes treated with DURAVYU were supplement-free at 16 weeks, compared to 50% in the control group.
DME, a complication of diabetes, can lead to severe vision loss or blindness. Current treatments often involve frequent injections, which can be burdensome for patients.
DURAVYU utilizes EyePoint’s Durasert E™ technology to deliver vorolanib, a tyrosine kinase inhibitor, in a bioerodible insert that provides sustained release. The treatment is under investigation and has not yet been approved by the FDA.
Full topline data from the VERONA trial is expected in the first quarter of 2025. EyePoint Pharmaceuticals is also conducting Phase 3 trials for DURAVYU in wet age-related macular degeneration (AMD (NASDAQ:AMD)), with results anticipated in 2026.
This news is based on a press release statement from EyePoint Pharmaceuticals.
In other recent news, EyePoint Pharmaceuticals has been making significant strides in its clinical trials and board appointments. The company has initiated the global Phase 3 LUGANO trial for its Duravyu treatment for wet Age-related Macular Degeneration (AMD), with over 150 sites committed to the trial. The company also anticipates the start of the LUCIA trial, another Phase 3 study, by the end of 2024. EyePoint Pharmaceuticals expects to share top-line data from these trials in 2026.
Analysts from various firms have maintained their confidence in EyePoint Pharmaceuticals. H.C. Wainwright reaffirmed its Buy rating and $30.00 price target for the company, while Jefferies initiated coverage with a Buy rating, indicating a potential upside of over 65%. Laidlaw also maintained its Buy rating and $50.00 price target. However, CapitalOne reaffirmed its Underweight rating with a price target of $35.00.
Changes to EyePoint Pharmaceuticals' Board of Directors include the appointment of industry veteran Fred Hassan and the resignations of Anthony P. Adamis, M.D., and David Guyer, M.D., due to their transition to full-time roles at Merck & Co. These developments underscore EyePoint's commitment to addressing the challenges of serious retinal diseases through its ongoing Phase 3 clinical trials and potential FDA approval of Duravyu.
InvestingPro Insights
EyePoint Pharmaceuticals' promising interim results for DURAVYU in treating diabetic macular edema are reflected in some of the company's recent financial metrics and analyst sentiments. According to InvestingPro data, EyePoint's revenue growth stands at 34.98% for the last twelve months as of Q2 2024, indicating a robust expansion in its business operations. This growth aligns with the positive clinical trial outcomes and potential market opportunities for DURAVYU.
However, investors should note that EyePoint is currently not profitable, with a negative gross profit margin of -54.83% for the same period. This is not uncommon for biotech companies in the development stage of promising treatments. An InvestingPro Tip highlights that the company is "quickly burning through cash," which is often necessary for funding extensive clinical trials like VERONA.
On a positive note, another InvestingPro Tip reveals that "4 analysts have revised their earnings upwards for the upcoming period," suggesting growing confidence in EyePoint's future performance, possibly influenced by the encouraging DURAVYU trial results.
For investors seeking a more comprehensive analysis, InvestingPro offers 8 additional tips for EyePoint Pharmaceuticals, providing a deeper understanding of the company's financial health and market position.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.