On Monday, Guggenheim reiterated its Buy rating and $68.00 price target for EyePoint Pharmaceuticals, Inc. (NASDAQ: NASDAQ:EYPT) following the release of interim data from a Phase II study. EyePoint Pharmaceuticals disclosed 16-week interim results from its VERONA study for Duravyu, a treatment for diabetic macular edema (DME). The study, which includes 27 participants, is assessing the efficacy of a single 2mg dose of aflibercept and two doses of Duravyu—high dose at 2.7mg and low dose at 1.3mg.
The high dose Duravyu group demonstrated a notable improvement from the other study arms in both visual acuity and central subfield thickness (CST). The improvement in visual acuity was measured at +8.9 letters compared to the control, while CST reduction was recorded at -37.6um versus the control. These findings were recorded at the 16-week mark of the study.
Improvements were observed as early as week 4 across all study arms. Despite strict rescue criteria initiated at week 12, the high dose Duravyu group continued to show a significant proportion of participants without the need for supplements (82%) compared to the aflibercept control (50% supplement free) and low dose arms (60% supplement free).
The safety profile of Duravyu was also highlighted, with no reported cases of endophthalmitis, vasculitis, or insert migration noted during the study period. With these promising early results, Guggenheim anticipates that EyePoint will likely pursue further development of Duravyu for DME treatment. The complete 6-month data from the study is expected to be available in the first quarter of 2025.
The firm also expects that these interim results will positively influence the ongoing wet Age-related Macular Degeneration (wAMD) pivotal studies. Guggenheim's continued endorsement of EyePoint Pharmaceuticals reflects confidence in the potential of Duravyu to address unmet needs in the treatment of eye diseases.
In other recent news, EyePoint Pharmaceuticals continues to make significant strides in the medical field. The company has reported promising interim results from its Phase II VERONA study for Duravyu, a potential treatment for diabetic macular edema (DME). The study demonstrated significant improvements in visual acuity and retinal thickness, which has been echoed by Laidlaw and H.C. Wainwright, both of which have reiterated their Buy ratings for EyePoint.
The company has also initiated the global Phase 3 LUGANO trial for Duravyu in wet age-related macular degeneration (AMD (NASDAQ:AMD)), with over 150 sites committed to the trial. EyePoint is also preparing to start the LUCIA trial, another Phase 3 study, by the end of 2024. These trials are being closely monitored by analysts, including Jefferies, which initiated coverage with a Buy rating, indicating a potential upside of over 65%.
EyePoint Pharmaceuticals has also seen changes to its Board of Directors, with 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. This, along with the ongoing trials and potential FDA approval of Duravyu, underscores EyePoint's commitment to addressing serious retinal diseases. The top-line results from these trials are expected in 2026, and investors and industry watchers are eagerly anticipating these outcomes.
InvestingPro Insights
To complement Guggenheim's optimistic outlook on EyePoint Pharmaceuticals (NASDAQ: EYPT), recent data from InvestingPro offers additional context for investors. Despite the promising interim results from the VERONA study, it's important to note that EYPT is currently not profitable, with a negative gross profit margin of -54.83% over the last twelve months as of Q2 2024. This aligns with an InvestingPro Tip indicating that the company suffers from weak gross profit margins.
However, there are positive signals as well. The company's revenue growth stands at 34.98% for the same period, suggesting increasing market traction for its products. Additionally, an InvestingPro Tip highlights that EYPT holds more cash than debt on its balance sheet, which could provide financial flexibility as it continues to develop Duravyu and other treatments.
Investors should be aware that EYPT's stock price has been volatile, with a significant 61.02% return over the past year, but a -11.21% return in the last week. This volatility is reflected in another InvestingPro Tip, which notes that stock price movements for EYPT are quite volatile.
For those seeking a more comprehensive analysis, InvestingPro offers 12 additional tips for EYPT, providing a deeper understanding of the company's financial health and market position.
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