Merck completes acquisition of EyeBio

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EyeBio is developing a pipeline of clinical and preclinical candidates for the prevention and treatment of vision loss associated with retinal vascular leakage.

Image credit: AdobeStock/kitipol

(Image credit: AdobeStock/kitipol)

Merck has completed its acquisition of Eyebiotech Limited.

According to the company, the acquisition strengthens and diversifies Merck’s pipeline with the addition of Restoret, a novel late-phase candidate for diabetic macular edema and neovascular age-related macular degeneration, as well as preclinical candidates.

Merck announced the completion of the acquisition of Eyebiotech Limited. EyeBio is now a wholly-owned subsidiary of Merck.

The deal is valued as high as $3 billion, including an upfont cash payment of $1.3 billion, along with the potential for an additional $1.7 billion in developmental, regulatory, and commercial milestone payments.

According to a news release,1 Under the terms of the agreement, Merck has acquired all outstanding shares of EyeBio, and Merck will record a charge of approximately $1.3 billion, and there is a further potential $1.7 billion in developmental, regulatory and commercial milestone payments.2

Dean Y. Li, PhD, president of Merck Research Laboratories, noted in a news release the EyeBio acquisition further diversifies the company’s 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,” Li said.

According to the news release, EyeBio’s lead candidate, Restoret (EYE103), is an investigational, potentially first-in-class tetravalent, tri-specific antibody that acts as an agonist of the Wingless-related integration site (Wnt) signaling pathway.

Based on positive results from the open-label Phase 1b/2a AMARONE study in patients with diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD), Restoret is 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.

The company noted in its news release that Restoret is an investigational, tetravalent, tri-specific Wnt antibody designed to address unmet medical need in patients with retinal diseases, including diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD). Restoret is administered as an intravitreal injection seeking to eliminate vascular leakage in retinal diseases by agonizing the Wnt pathway with the goal of restoring and maintaining the blood-retinal barrier. Preclinical evidence indicates that agonizing the Wnt pathway in the retina may reduce vascular leakage.1

Moreover, additional pipeline candidates include clinical and preclinical assets being developed for the prevention and treatment of vision loss associated with retinal vascular leakage, a known risk factor for retinal diseases.

The acquisition was first announced in late May, when the companies announced a definitive agreement.

According to a previous news release, EyeBio is developing a pipeline of clinical and preclinical candidates for the prevention and treatment of vision loss associated with retinal vascular leakage, a known risk factor for retinal diseases.2

The company’s lead candidate, EYE103 (Restoret), is an investigational, potentially first-in-class tetravalent, tri-specific antibody that acts as an agonist of the Wingless-related integration site (Wnt) signaling pathway.2

Based on positive results from the open-label Phase 1b/2a AMARONE study (NCT05919693)in patients with diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD), EYE103 is anticipated to advance into a pivotal Phase 2b/3 trial to investigate the treatment of patients with DME in the second half of 2024.

According to the company, EYE103 (Restoret) is an investigational, potentially first-in-class tetravalent, tri-specific Wnt antibody designed to address unmet medical need in patients with retinal diseases, including diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD). It is administered as an intravitreal injection seeking to eliminate leakage in retinal vascular diseases by agonizing the Wnt pathway with the goal of restoring and maintaining the blood-retinal barrier. Preclinical evidence indicates that agonizing the Wnt pathway in the retina may reduce vascular leakage.2

The company noted in a news release2 that the Week 12 data from AMARONE demonstrated EYE103 was well-tolerated, with no drug-related adverse events, drug-related serious adverse events, or intraocular inflammation reported. Patients with DME (n = 26) received EYE103 as monotherapy, manifesting a mean improvement in best-corrected visual acuity of +11.2 letters and a mean reduction in retinal thickness of -143 µm, as measured by optical coherence tomography (OCT).

Moreover, according to the news release, similar outcomes were observed in patients with NVAMD (n=5), who received EYE103 in combination with aflibercept. The data demonstrated that multiple monthly doses of EYE103, as both monotherapy and in combination with aflibercept, were well-tolerated.

References:
  1. Merck Completes Acquisition of EyeBio. Merck.com. Accessed July 15, 2024. https://www.merck.com/news/merck-completes-acquisition-of-eyebio/
  2. EyeBio Announces Positive Visual, Anatomic and Safety Data from First-in-Human Ph1b/2a AMARONE Trial of Restoret at Macula Society Annual Meeting. www.businesswire.com. Published February 13, 2024. Accessed February 13, 2024. https://www.businesswire.com/news/home/20240212626117/en/EyeBio-Announces-Positive-Visual-Anatomic-and-Safety-Data-from-First-in-Human-Ph1b2a-AMARONE-Trial-of-Restoret-at-Macula-Society-Annual-Meeting
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