MSD (Merck & Co) has completed the acquisition of EyeBio, making it a wholly-owned subsidiary and significantly bolstering its ophthalmology portfolio. The acquisition, initially announced in May 2024, includes an upfront cash payment of $1.3 billion and up to $1.7 billion in milestone payments contingent on meeting developmental, regulatory, and commercial goals.
Under the terms of the deal, Merck, through a subsidiary, has acquired all the outstanding shares of the UK-based biotech company EyeBio. This strategic acquisition includes EyeBio’s lead asset, Restoret (EYE-103), a tetravalent, tri-specific antibody targeting the Wingless-related integration site (Wnt) signaling pathway. Restoret holds significant potential for treating diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD), two prevalent retinal diseases.
Restoret, administered as an intravitreal injection, aims to restore the blood-retinal barrier by activating the Wnt pathway. This innovative approach addresses a critical need in retinal disease treatment. Following promising results from the open-label Phase Ib/IIa AMARONE study in patients with DME and NVAMD, Restoret is poised to advance into a significant Phase IIb/III trial for diabetic macular edema (DME) in the latter half of 2024. These trials will be crucial in further establishing the safety and efficacy of Restoret, potentially bringing a novel treatment option to patients suffering from these debilitating conditions.
Merck Strengthens Ophthalmology Leadership with EyeBio Acquisition and Innovative Pipeline Expansion
In addition to Restoret, EyeBio’s pipeline includes several other clinical and preclinical assets aimed at preventing and treating vision loss due to retinal vascular leakage, a common risk factor in many retinal diseases. These assets further enhance Merck’s capabilities in ophthalmology, positioning the company as a leader in the development of innovative treatments for retinal disorders.
Dr. Dean Li, President of Merck Research Laboratories, expressed his enthusiasm about the acquisition, stating, “The EyeBio acquisition further diversifies our late-stage pipeline with the addition of a promising candidate based on novel biology and genetics for the treatment of certain retinal diseases. We are excited to welcome the EyeBio team and look forward to working together to advance Restoret for the patients that need it.”
The acquisition of EyeBio underscores Merck’s commitment to advancing its ophthalmology portfolio through strategic investments and innovative science. The RMAT designation for Restoret, granted based on the promising early clinical data, provides additional momentum by facilitating increased interactions with the FDA. These interactions are designed to streamline the drug development and review process, ensuring that promising therapies can reach patients more quickly.
Merck and EyeBio Collaboration Accelerates Innovative Retinal Disease Therapies with Comprehensive Safety Measures
EyeBio’s expertise in retinal diseases and its robust pipeline align well with Merck’s strategic goals of addressing unmet medical needs through innovation. The collaboration between the two companies is expected to accelerate the development of cutting-edge therapies for retinal diseases, potentially transforming the treatment landscape.
The comprehensive approach to data collection and analysis in the clinical trials, including the thorough collection of adverse events (AEs) and serious adverse events (SAEs), ensures a comprehensive safety profile for Restoret. The study protocols (SP) and statistical analysis plans (SAP) are meticulously designed to include all events leading to hospitalization or death, providing a clearer picture of the treatment’s safety profile.
To ensure the completeness and reliability of the data, robust training programs for healthcare providers involved in the study are essential. This includes regular site monitoring visits and mandatory data fields in the German Hemophilia Registry (DHR). The SP must clearly outline these measures to ensure consistent data collection across all study centers.
Merck’s Acquisition of EyeBio Advances Retinal Disease Treatments with Rigorous Data Integrity and Analysis
The statistical methods used in the study are clearly defined and justified, with recommendations from regulatory bodies such as the G-BA to use a shifted hypothesis threshold to account for the non-randomized study design. Sensitivity analyses are conducted to address potential biases and ensure the robustness of the study results. A critical aspect of the study is the collection of baseline data, ensuring that all inclusion and exclusion criteria are operationalized at the index date.
The identification and management of confounders require a systematic literature review and expert consultation, thoroughly documented in the SP to ensure all relevant confounders are considered in the analysis. This rigorous approach underscores the commitment to maintaining data integrity and ensuring reliable outcomes.
Merck’s acquisition of EyeBio marks a significant step forward in the company’s efforts to expand its ophthalmology portfolio and address the unmet needs of patients with retinal diseases. By leveraging EyeBio’s innovative therapies and expertise, Merck is well-positioned to make substantial advancements in the treatment of retinal disorders, offering new hope to patients worldwide.
Resource: Merck, July 12, 2024
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