Less than 2 months after announcing its plans for a major ophthalmic expansion, Merck & Co. has officially acquired Eyebiotech Limited (EyeBio), making the biotech company a wholly-owned subsidiary of Merck.
First up, let’s talk Merck.
The Germany-based Merck Group is a multinational pharmaceutical giant with U.S. headquarters located in Rahway, New Jersey.
- Its focus: Delivering health solutions via prescription medicines, vaccines, biologic therapies, and animal health products
- To note: While extensive in its product offerings—focusing primarily on oncology and cardiovascular—the company has no prior investments within the ophthalmic industry
Speaking of ophthalmics …
EyeBio is a newer (founded in 2021 versus Merck Group’s historic roots), United Kingdom-based, privately held ophthalmology biotechnology company developing advanced therapies for ocular diseases.
- Most notable: Restoret (EYE103), its lead asset, is currently in clinical development to treat retinal diseases characterized by vascular leakage via intravitreal injection
Now a refresh on this acquisition.
As we first reported in May 2024, Merck is assuming ownership of EyeBio’s outstanding shares (up to $3 billion). This includes:
- Upfront payment of $1.3 billion in cash in Q3 2024
- Broken down: an estimated $0.50 per share
- Potential for $1.7 billion in the following payments:
- Developmental
- Regulatory
- Commercial milestone
And the reason for this ophthalmic shift?
That lead asset: Restoret (as well as EyeBio’s retinal disease-focused pipeline).
“As a subsidiary of Merck, EyeBio will be positioned to tap into the resources and infrastructure needed to support the clinical, regulatory and commercial development of these candidates,” David R. Guyer, MD, EyeBio CEO, president, and co-founder, previously stated.
- Even further: The purchase “further diversifies” Merck’s late-stage pipeline with a novel biology and genetics-based retinal disease treatment, according to Dean Y. Li, MD, PhD, president of Merck Research Laboratories.
Give me a rundown on this lead asset.
Here are the basics on Restoret.
What it is: The tetravalent, tri-specific antibody is an agonist of the Wingless-related integration site (Wnt) signaling pathway.
- Refresh on the Wnt signaling pathway: This pathway is part of a group of signal transduction pathways that start with proteins passing signals into a cell through cell surface receptors.
And why is this important to know?
Wnt genes code for proteins that are responsible for the normal development and maintenance of the blood-retinal barrier (BRB).
- Plus: The signaling of Wnt is known to have a key role in vascular integrity maintenance and vascular retinal leakage (due to defects)
Gotcha. Now back to Restoret.
Let’s dive into the mechanism of action of Restoret (which is delivered via intravitreal [IV] injection).
How it works: The antibody is intended to eliminate leakage in retinal vascular diseases by forcing the Wnt pathway to restore and maintain the BRB—currently an unmet medical need for patients with such diseases.
Restoret targets:
- Wet age-related macular degeneration (AMD)
- Diabetic macular edema (DME)
- Familial exudative vitreoretinopathy (FEVR)
What’s the clinical data on it so far?
Twelve-week data from the multicenter, open-label, Anti-permeability Mechanism and Age-Related Ocular Neovascularization Evaluation (AMARONE) phase 1b/2a trial (NCT05919693) was reported in February 2024.
- The first-in-human (FIH)study’s disease focus: wet AMD and DME
- The outcome measures:
- Primary: Adverse events (AEs)
- Secondary: Best-corrected visual acuity (BCVA)
And what’s been found so far?
In general, Restoret was well-tolerated, with no reports of drug-related AEs or serious AEs, including intraocular inflammation (IOI).
The significance: This study is noted as being the first-ever “clinical use of a Wnt pathway agonist to address retinal disease,” per Dr. Guyer.
That sounds promising … so what’s next for Restoret?
First: A pivotal phase 2b/3 trial (for DME alone) is expected to kick off later this year.
Then: The FIH AMARONE study is slated to conclude in December 2024 (with updated data to follow).