Merck (NYSE: MRK) has recently announced the completion of the acquisition of Eyebiotech Limited (EyeBio), now becoming a wholly-owned subsidiary of Merck. EyeBio was founded in 2021 by David Guyer, M.D., and Tony Adamis, M.D., to develop ocular therapies including the development of a Wnt agonist, a tetravalent tri-specific agonist antibody (Restoret), aimed to eliminate leakage in vascular disease and maintain the blood-retinal barrier. According to Merck, Dr. Dean Y. Li, president of Merck Research Laboratories, stated that, “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”. Restoret is now scheduled to advance into a pivotal Phase 2b/3 trial to evaluate its potential for the treatment of patients with DME in the second half of 2024.
Previous data announced earlier this year showed that 12 week results from a first-in-human Phase 1b/2a trial (AMARONE), reported a proof of concept with strong visual and anatomic outcomes. Restoret was well-tolerated, with no drug-related adverse events, drug-related serious adverse events, or intraocular inflammation reported. Patients with DME (n=26) received Restoret as monotherapy, manifesting a mean improvement in BCVA of +11.2 letters and a mean reduction in retinal thickness of -143 microns, as measured by optical coherence tomography (OCT). Similar outcomes were observed in patients with NVAMD (n=5), who received Restoret in combination with aflibercept. The data demonstrated that multiple monthly doses of Restoret, as both monotherapy and in combination with aflibercept, were well-tolerated. Commenting on these results earlier, Charles C. Wykoff, MD, PhD., stated that, “these data from AMARONE are unique and impressive. While anti-VEGF monotherapies have proven valuable, many patients still do not achieve optimal outcomes and there remains substantial unmet need for therapeutics with alternative mechanisms of action that can improve outcomes for patients with exudative retinal diseases including diabetic macular edema and wet macular degeneration. While early data thus far, it is exciting to see these meaningful anatomic and visual improvements using this differentiated and fascinating Wnt agonist, especially in the absence of VEGF inhibition”.
Under the terms of the agreement, Merck, through a subsidiary, “has acquired all outstanding shares of EyeBio”. As previously disclosed, this transaction is being accounted for as an asset acquisition. Merck 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.