WATERTOWN, Mass. - EyePoint Pharmaceuticals, Inc. (NASDAQ: NASDAQ:EYPT), a biopharmaceutical company, announced today its upcoming Phase 3 clinical trial plans for DURAVYU™, its treatment for wet age-related macular degeneration (AMD (NASDAQ:AMD)). The company is set to initiate the LUGANO and LUCIA pivotal non-inferiority trials in the second half of 2024, following a positive End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA).
The company's R&D Day, taking place today, will highlight the Phase 3 trial designs for DURAVYU™ in wet AMD, which is expected to enroll around 400 patients per trial. These patients, both previously treated and treatment-naïve, will be randomly assigned to either a 2.7mg dose of DURAVYU or an aflibercept control. The primary efficacy endpoint will be the non-inferiority to the control as measured by the change in Best Corrected Visual Acuity (BCVA) twelve months after two DURAVYU injections administered six months apart.
EyePoint also released favorable twelve-month safety and efficacy data from the Phase 2 DAVIO 2 clinical trial of DURAVYU for wet AMD. The data showed a favorable safety profile with no drug-related ocular or systemic serious adverse events (SAEs). Additionally, the visual acuity outcomes were statistically significant and nearly identical to the aflibercept control arm through 12 months after a single injection of DURAVYU. Approximately half of the treated study eyes were anti-VEGF supplement free after the injection.
Furthermore, the company has completed enrollment for the VERONA trial, a Phase 2 trial of DURAVYU in diabetic macular edema (DME) patients. To date, DURAVYU has been well-tolerated with no reported drug-related ocular or systemic SAEs in this trial.
DURAVYU is a sustained-release drug delivery treatment that combines vorolanib, a selective tyrosine kinase inhibitor, with EyePoint's proprietary Durasert E™ technology. It is administered as a single intravitreal injection and is designed to offer sustained treatment for approximately nine months.
In other recent news, EyePoint Pharmaceuticals has made significant amendments to its incentive plans and reported mixed results for its first quarter of 2024. The company's total net revenue reached $11.7 million, surpassing the estimated $11 million, but the net loss for the quarter was higher than expected at $29.3 million. Analyst firms H.C. Wainwright and Mizuho have both adjusted their 12-month price targets for EyePoint, setting new targets at $30, down from previous targets of $33 and $39 respectively, but maintaining their Buy ratings.
EyePoint Pharmaceuticals also announced interim results from its Phase 2 PAVIA clinical trial for DURAVYU™, a treatment for non-proliferative diabetic retinopathy (NPDR). The treatment did not meet the primary endpoint of the trial, but showed a favorable safety profile and reduced disease progression rates at nine months. The company is also preparing for the Phase 3 LUGANO trial of DURAVYU for the treatment of wet Age-related Macular Degeneration (AMD), expected to commence in the second half of 2024. These are recent developments in the company's operations.
InvestingPro Insights
EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT) is on the brink of advancing its treatment for wet age-related macular degeneration (AMD) into pivotal Phase 3 trials, a critical juncture for the company's future. As investors and stakeholders monitor the progress of DURAVYU™, it is essential to contextualize the company's financial health and market performance.
InvestingPro data reveals a challenging financial landscape for EyePoint, with a negative gross profit margin of -71.2% over the last twelve months as of Q1 2024, indicating that the company spends more on the direct costs of producing its products than it earns from them. Additionally, the company's operating income margin stands at -171.2%, reflecting significant operating losses in relation to its revenue.
Despite these financial headwinds, EyePoint holds a key strategic advantage: its balance sheet shows more cash than debt, providing a buffer as it navigates the capital-intensive phases of clinical trials. Moreover, the company's liquid assets exceed its short-term obligations, suggesting a degree of financial flexibility in the near term.
Investors should note, however, that the company's stock price has experienced substantial volatility, with a 6-month price total return of -65.03% as of the same period. This volatility is echoed in the InvestingPro Tips, which highlight that analysts have revised their earnings expectations downwards for the upcoming period and do not anticipate profitability for EyePoint this year. Additionally, the stock has fared poorly over the last month, with a price total return of -25.99%.
For those seeking a more in-depth analysis, there are 12 additional InvestingPro Tips available for EyePoint Pharmaceuticals, which can be accessed at https://www.investing.com/pro/EYPT. These tips provide valuable insights that can help investors make informed decisions about their investments in the company.
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