MSD Completes $3 Billion Acquisition of EyeBio, Gaining Novel Retinal Disease Candidate Restoret
核心洞察
MSD has completed its acquisition of EyeBio (搜索) for $3 billion, including $1.3 billion upfront and $1.7 billion in milestones, strengthening its ophthalmology pipeline.
The deal centers on Restoret, a potentially first-in-class tetravalent, tri-specific antibody targeting the Wnt signaling pathway (搜索) for diabetic macular edema (搜索) and neovascular age-related macular degeneration (搜索).
Restoret showed positive results in the Phase 1b/2a AMARONE study and is scheduled to advance into pivotal Phase 2b/3 trials for diabetic macular edema (搜索) in the second half of 2024.
MSD has completed its $3 billion acquisition of ophthalmology biotech EyeBio (搜索), gaining access to a potentially first-in-class retinal disease candidate that could address significant unmet medical needs in diabetic macular edema (搜索) and age-related macular degeneration. The transaction, which includes an upfront cash payment of $1.3 billion and up to $1.7 billion in milestone payments, was finalized in July 2024, making EyeBio a wholly-owned subsidiary of MSD.
Novel Mechanism Targets Wnt Pathway
The centerpiece of the acquisition is Restoret (EYE103), an investigational tetravalent, tri-specific antibody that acts as an agonist of the Wingless-related integration site (Wnt) signaling pathway. Unlike current standard-of-care anti-VEGF (搜索) therapies, Restoret is designed to eliminate vascular leakage in retinal diseases by agonizing the Wnt pathway with the goal of restoring and maintaining the blood-retinal barrier.
"The EyeBio (搜索) 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," said Dr. Dean Y. Li, president, MSD Research Laboratories. "We are excited to welcome the EyeBio team and look forward to working together to advance Restoret for the patients that need it."
Positive Phase 1b/2a Results Drive Pivotal Trial Plans
Restoret demonstrated positive results in the open-label Phase 1b/2a AMARONE study in patients with diabetic macular edema (搜索) (DME) and neovascular age-related macular degeneration (搜索) (NVAMD). Based on these encouraging data, the drug is scheduled to advance into a pivotal Phase 2b/3 trial to evaluate its potential for treating patients with DME in the second half of 2024.
The AMARONE study was conducted in two parts: an initial multiple ascending dose (MAD) portion focusing on safety, followed by a dose-finding stage examining both safety and preliminary efficacy measures. EyeBio (搜索) completed an upscaled Series A financing of $130 million in November 2023 to support Restoret's continued development.
Addressing Limitations of Current Therapies
Current anti-VEGF (搜索) therapies, while effective, often produce unpredictable results and frequently fail to fully resolve vascular leakage, meaning vision continues to deteriorate in many patients. Restoret is specifically designed to address this persistent retinal fluid leakage that remains despite treatment with standard anti-VEGF therapies.
The market opportunity is substantial, with VEGF (搜索)-directed drugs generating billions in annual sales. Bayer and Regeneron's Eylea (aflibercept) leads the ophthalmic anti-VEGF category with approximately $9.5 billion in sales last year, while Roche's newer VEGFxAng-2 (搜索) bispecific antibody Vabysmo (faricimab) reached $2.7 billion in sales and nearly $930 million in the first quarter of 2024 alone.
Strategic Pipeline Diversification
The acquisition represents MSD's continued strategy of bolstering its pipeline through targeted acquisitions, particularly as the company prepares for the end of patent protection for its $25 billion-a-year cancer blockbuster Keytruda (pembrolizumab) from 2028. The company has previously acquired Acceleron for $11.5 billion in 2021 and Prometheus for $10.8 billion in 2022.
MSD largely exited the ophthalmology sector a decade ago but has maintained selective interest in the field. The company previously licensed a drug for geographic atrophy from NGM Bio in 2015, though that alliance was dissolved after the candidate failed a Phase 2 trial in 2022.
Financial Impact and Future Outlook
MSD will record a charge of approximately $1.3 billion, or approximately $0.50 per share, in the third quarter of 2024, which will be included in non-GAAP results. The transaction is being accounted for as an asset acquisition, and the company plans to provide an update to its full-year financial outlook when it reports second-quarter 2024 results on July 30.
Beyond Restoret, the acquisition includes additional clinical and preclinical pipeline candidates being developed for the prevention and treatment of vision loss associated with retinal vascular leakage, a known risk factor for retinal diseases.