[Edaily Reporter YU JIN-HEE ] Ingenia Therapeutics (Ingenia), a developer of treatments for microvascular diseases that has begun the public offering process for a KOSDAQ listing, has declared a paradigm shift in the age-related macular degeneration (AMD) treatment market with the full support of global pharmaceutical giant Merck (MSD).

“Response in Just One Week, Normalization in Four Weeks”… Significantly Outperforms Existing Blockbuster Drugs

According to industry sources on the 23rd, Merck recently raised expectations for the clinical success of Ingenia’s age-related macular degeneration (AMD) treatment “IGT-427” (Merck code name: MK-8748) by presenting clinical data that outperforms existing blockbuster therapies during a global investor relations (IR) briefing.

The global market for retinal disease treatments is valued at approximately $15.8 billion (about 23 trillion won) annually. Drugs such as Regeneron’s “Eylea” (Aflibercept) and Roche’s “Bavismo” (Faricimab) dominate the market. However, these treatments rely solely on the “anti-vascular endothelial growth factor” (anti-VEGF) mechanism, and their limitations have been identified as a lack of response in up to 60% of patients and the need for frequent intravitreal injections every 4 to 8 weeks.

In contrast, Ingenia’s core pipeline candidate, IGT-427, is based on its proprietary “LCIDEC” platform. It features an innovative dual-action mechanism that directly activates the TIE2 receptor on the vascular cell membrane to repair damaged microvascular structures while simultaneously drawing pathogenic proteins into the cell to degrade them.

According to Phase 2 clinical trial (RIOJA Trial) data for patients with wet age-related macular degeneration (wAMD), presented in Merck’s global IR materials, IGT-427 (up to 10 mg) significantly outperformed competing drugs in terms of efficacy and speed at the 12-week assessment. In fact, all patients treated with IGT-427 responded to the drug within just one week. It normalized retinal structure and significantly reduced retinal edema in just four weeks. A detailed comparison of key endpoints shows that IGT-427 achieved an overwhelming reduction of 218 μm in central retinal thickness (CST)—a measure of edema reduction in the diseased retina. This compares to the 3rd-generation therapy Bavismo 6 mg, which acts via an indirect TIE2 activation mechanism(130–140 μm reduction), as well as the second-generation standard treatments—Regeneron’s Eylea 2 mg (130–135 μm reduction) and the high-dose Eylea HD 8 mg (135–140 μm reduction)—by a wide margin.

In terms of efficacy in improving best-corrected visual acuity (BCVA)—a measure of actual visual recovery in patients—IGT-427 demonstrated an average improvement of 7.8 letters. Compared to competing products—Bavismo, which showed an improvement of 5–6.5 letters; Eylea 2 mg, which showed an improvement of 5–6 letters; and Eylea HD 8 mg, which showed an improvement of 5–6.5 letters—IGT-427 also demonstrated the greatest improvement in visual acuity. In terms of duration of efficacy, the dosing interval can be extended from the current 4–8 weeks to up to 16–24 weeks, making it a fifth-generation treatment that reduces patient discomfort and maximizes convenience.

Merck Prepares for Keytruda Patent Expiration... Deploys ‘Top 10 Core Assets’ Valued at 100 Trillion

This overwhelming competitive edge has led to large-scale investment from Merck, one of the world’s top five pharmaceutical companies. After Ingenia licensed IGT-427 to EyeBio, a UK-based ophthalmology-focused biotech company, for 1 trillion won in 2022, Merck abruptly acquired EyeBio in 2024 for up to $3 billion (approximately 4.5 trillion won), incorporating the compound into its official pipeline. Merck is actively spearheading the development of IGT-427 in anticipation of the expiration of the U.S. patent for its blockbuster immuno-oncology drug “Keytruda” (KEYTRUDA) in 2028 and the subsequent loss of its exclusive rights.

KEYTRUDA recorded sales of $31.7 billion (approximately 49 trillion won) last year, accounting for half of Merck’s total revenue ($65 billion); however, after peaking at $35 billion in 2028, a revenue shortfall is inevitable. Consequently, Merck has designated its ophthalmic disease pipeline—which includes IGT-427—as one of the company’s “Ten Key Programs,” expected to generate a total commercial value of over $70 billion (approximately 107 trillion won) by the mid-2030s. Merck recently reaffirmed its commitment by enrolling patients in two additional global Phase 3 clinical trials for diabetic macular edema (DME), following two trials for wet age-related macular degeneration (wAMD), thereby simultaneously advancing a total of four late-stage clinical trials (involving 3,984 participants). The schedule calls for the completion of clinical trials in 2028, followed by U.S. Food and Drug Administration (FDA) approval in 2029 and commercialization in 2030.

As Merck’s commercialization roadmap takes shape, Ingenia’s future financial stability and shareholder value are also expected to rise sharply. IGT-427 has the potential to expand to up to seven ophthalmic indications, including the combined market for three major eye diseases—age-related macular degeneration, diabetic macular edema, and branch retinal vein occlusion (BRVO)—which is projected to reach $19.8 billion by 2029. Since the 2022 technology export, Ingenia has already generated cumulative revenue of $38.37 million (approximately 56 billion won) from non-refundable upfront payments and milestones, achieving its first profit since the company’s founding in 2024.

Starting with the global product launch in 2030, tiered running royalty revenue linked to Merck’s worldwide sales will be added in earnest, serving as a long-term source of cash flow. Based on the approximately 60 billion won in funds raised through the IPO, Ingenia will pursue a series of technology exports for its follow-on pipeline to diversify its growth engines. “IGT-303,” a treatment for chronic kidney disease currently undergoing Phase 1/2a clinical trials in Australia, New Zealand, and South Korea, is scheduled to begin discussions on a major partnership with a global big pharma company as soon as safety and preliminary efficacy data are secured by the end of this year.

An Ingenia official emphasized, “Building on the proven excellence of our microvascular recovery technology platform, validated through Merck, we will deliver consistent clinical results and licensing agreements following the IPO,” adding, “We will leap forward as a leading biotech company that proves its value through tangible results and global data, going beyond mere expectations.”