Both doses were noninferior to ranibizumab at Week 52, while safety imbalances await full data
Key Takeaways
- Remigromig 0.5 mg and 0.8 mg each demonstrated noninferiority to ranibizumab 0.5 mg on the Week 52 vision endpoint.
- Merck reported higher rates of proliferative diabetic retinopathy, vitreous hemorrhage and adverse event-related discontinuations with remigromig.
- Detailed efficacy and safety results will be presented on October 10, 2026.
Data Snapshot
| Category | Details |
|---|---|
| Company | Merck, through EyeBio |
| Candidate | Remigromig; MK-3000, formerly EYE103 and Restoret |
| Trial | BRUNELLO, NCT06571045 |
| Phase | Pivotal Phase 2b/3 |
| Participants | 984 adults with diabetic macular edema |
| Treatment | Remigromig 0.5 mg or 0.8 mg versus ranibizumab 0.5 mg |
| Administration | Intravitreal injection every four weeks during Year 1 |
| Primary efficacy endpoint | Mean change in best-corrected visual acuity at Week 52 |
| Result | Both remigromig doses demonstrated noninferiority |
What Happened
Merck reported that both doses of remigromig met the primary efficacy endpoint in BRUNELLO, the first of two pivotal Phase 2b/3 studies in diabetic macular edema, or DME.
Remigromig 0.5 mg and 0.8 mg each demonstrated noninferiority to ranibizumab 0.5 mg for mean change from baseline in best-corrected visual acuity at Week 52.
However, Merck has not disclosed the actual letter gains, treatment differences, confidence intervals, noninferiority margin or anatomical outcomes. The announcement confirms that the study succeeded, but not how closely remigromig performed relative to ranibizumab.
Safety is the main unresolved issue. Merck described remigromig as generally well tolerated but reported higher rates of proliferative diabetic retinopathy, vitreous hemorrhage and treatment discontinuations due to adverse events than with ranibizumab. The number, severity, timing and dose relationship of these events remain undisclosed. (Merck BRUNELLO results)
Why It Matters
Remigromig is a non-VEGF treatment being developed for retinal vascular leakage. Its Phase 2b/3 success supports a new treatment approach in a market dominated by injectable anti-VEGF therapies.
The commercial benchmark, however, extends beyond ranibizumab. Widely used treatments such as Eylea, Eylea HD and Vabysmo already compete through established efficacy and longer treatment intervals.
| Company | Product | Status in DME | Clinical positioning |
|---|---|---|---|
| Merck/EyeBio | Remigromig | Phase 2b/3 | Non-VEGF challenger; every four weeks in Year 1 |
| Roche/Genentech | Lucentis | Approved | Established monthly anti-VEGF; BRUNELLO comparator |
| Regeneron/Bayer | Eylea/Eylea HD | Approved | Major anti-VEGF option with extended-interval dosing |
| Roche/Genentech | Vabysmo | Approved | VEGF-A/Ang-2 therapy with individualized dosing |
Noninferiority to ranibizumab validates remigromig’s activity but does not establish superiority over current DME treatments. A competitive advantage will depend on safety, durability, performance in anti-VEGF partial responders and the Year 2 personalized treatment interval.
Fierce Biotech noted that the pivotal result supports the drug’s efficacy hypothesis while leaving its commercial differentiation unresolved. (Fierce Biotech)
For the protein-level biology, read my Science analysis of Merck’s Remigromig Mechanism: FZD4–LRP5 Wnt Signaling in Diabetic Macular Edema.
EyeBio Acquisition Faces Its Next Test
Merck acquired EyeBio in 2024 for $1.3 billion upfront and up to $1.7 billion in milestone payments, representing a potential total value of $3 billion.
At approximately KRW 1,358 per U.S. dollar on September 25, 2026, this equals about KRW 1.8 trillion upfront and KRW 4.1 trillion in total potential value. Remigromig was the lead asset behind the transaction. (Merck EyeBio acquisition)
BRUNELLO reduces the efficacy risk surrounding that investment, but the safety imbalance and competitive profile remain unresolved. The ongoing BAROLO study is expected to provide a second pivotal test of remigromig in DME.
BP View
BRUNELLO is a meaningful clinical win because remigromig matched an established anti-VEGF treatment through a different therapeutic approach.
The result is not yet a complete commercial win. Merck must show that the safety findings are manageable and that remigromig offers a practical advantage over longer-acting anti-VEGF options.
The full BRUNELLO results will be presented at the American Academy of Ophthalmology Annual Meeting on October 10 at 5:10 p.m. Central Time—October 11 at 7:10 a.m. in Korea. Until then, remigromig should be viewed as a successful pivotal program with an unresolved safety and differentiation profile.
Related Post
For another look at how major pharmaceutical companies are expanding into retinal disease, read my previous analysis of Eli Lilly Strikes $475 M Gene Therapy Deal with MeiraGTx for Rare Retinal Disease.
About BP
Biopharma Perspective provides concise analysis of pharmaceutical clinical results, regulatory decisions and business strategy.
This article is for informational purposes only and does not constitute medical or investment advice.
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