Merck (MSD) has expanded the development scope of Ingenia Therapeutics' ophthalmology drug candidate "IGT-427." With the start of two global phase 3 trials in patients with diabetic macular edema, in addition to neovascular age-related macular degeneration, the treatment targets now cover two diseases, and the number of ongoing clinical trials has increased to four.
According to ClinicalTrials.gov, a U.S. clinical trial registry, MSD recently registered detailed plans for two global phase 3 studies of IGT-427 (MK-8748) in diabetic macular edema (DME).
The newly registered trials will enroll 960 and 1,104 patients, respectively, and will begin on Aug. 28 and Sept. 30. The expected completion dates are October and November 2029.
Since March, MSD has also been conducting two global phase 2b/3 trials, each enrolling 960 patients with neovascular age-related macular degeneration (wAMD). Including the new trials, IGT-427 will be in four late-stage global studies across the two diseases, enrolling a total of 3,984 patients concurrently.
All four trials use Regeneron's macular degeneration treatment "Eylea (2mg)" as the control. They will primarily assess visual acuity improvement and whether dosing intervals can be extended (durability of effect).
IGT-427 is an antibody drug candidate that suppresses vascular leakage and restores damaged vascular function. It is based on technology that directly activates the Tie2 receptor, which is involved in vascular stabilization, and acts through a different mechanism than existing anti-VEGF therapies.
Ingenia Therapeutics developed this molecule and out-licensed it to EyeBio in 2022 in a deal worth about 1 trillion won. After MSD acquired EyeBio in 2024, MSD began conducting the global trials.
Founded in 2018 in Boston, Ingenia Therapeutics is a biotech venture developing new drugs based on microvascular protection and restoration antibody technology. Founder Han Sang-yeol established the company using foundational technology secured while conducting microvascular research at the Institute for Basic Science (IBS).
At a recent initial public offering (IPO) briefing, CEO Han Sang-yeol said, "MSD aims to complete IGT-427's clinical program in 2028, obtain U.S. Food and Drug Administration (FDA) approval in 2029, and launch in 2030," adding, "We expect it to grow into a blockbuster with annual sales exceeding $5 billion."
Meanwhile, Ingenia Therapeutics is pursuing a KOSDAQ special technology listing. In last year's technology evaluation, it received an A grade from both evaluating institutions, and its corporate value is being assessed at up to 780 billion won. The company is conducting book-building for institutional investors from the 20th to the 24th of this month.