Restoret (EYE103/MK-3000): A Novel Wnt Pathway Agonist for Retinal Diseases

I. Introduction

Restoret is an investigational therapeutic agent currently under development for the treatment of debilitating retinal vascular diseases. Spearheaded by EyeBiotech Ltd., now a subsidiary of Merck & Co., Inc., Restoret, also identified by the developmental codes EYE103 and MK-3000, represents a novel approach targeting primarily diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD).[1] Its distinction lies in its mechanism of action, which involves the activation of the Wingless-related integration site (Wnt) signaling pathway, a departure from existing therapeutic strategies predominantly focused on vascular endothelial growth factor (VEGF) inhibition.[1] This report provides a comprehensive overview of Restoret, detailing its identity, mechanism, therapeutic indications, clinical development program, efficacy and safety findings, pharmacokinetic considerations, and regulatory outlook.

II. Drug Identity and Manufacturer

A. Name

The investigational drug is known as Restoret™. Its developmental codenames include EYE103 and, following its acquisition by Merck, MK-3000.[1] It is crucial to distinguish Restoret from "Restoril," a brand name for temazepam, which is a benzodiazepine medication used for insomnia and is entirely unrelated to this ophthalmic therapeutic.[5]

B. Manufacturer

Restoret was initially developed by EyeBiotech Limited (EyeBio).[7] In a significant strategic move, Merck & Co., Inc. (known as MSD outside the United States and Canada) completed the acquisition of EyeBio, making EyeBio a wholly-owned subsidiary of Merck. This acquisition has integrated Restoret into Merck's late-stage pipeline.[1]

C. Drug Class and Type