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Merck's remigromig meets main goal in pivotal eye disease trial

Merck's remigromig meets main goal in pivotal eye disease trial

New Capabilities

Matched the anti-VEGF standard in a pivotal trial, but a safety signal and a 60% analyst forecast cut weigh on its commercial case

October 10th, 2026: Full year-one results presented at AAO

Overview

Updated Oct 26

Jefferies cut its risk-adjusted peak sales estimate for remigromig by 60%, to $300 million. The change followed Merck's presentation of full one-year BRUNELLO results at the American Academy of Ophthalmology meeting in October. In the 984-patient trial, the drug matched ranibizumab on vision but produced smaller gains and higher rates of proliferative diabetic retinopathy.

Remigromig activates the Wnt signaling pathway rather than blocking VEGF, the mechanism behind the drugs that dominate DME treatment. Merck paid $1.3 billion upfront for EyeBio in 2024 to acquire it. A second pivotal trial, BAROLO, is expected to report in March 2027, and Merck has said it will discuss the BRUNELLO data with regulators.

Why it matters

Up to 40% of diabetic macular edema patients fail current drugs, and remigromig would give them a first new mechanism in 20 years.

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Key Indicators

984
Patients enrolled in BRUNELLO trial
Randomized 1:1:1 to low-dose, high-dose remigromig, or ranibizumab.
$3B
Potential total deal value for remigromig
Merck paid $1.3 billion upfront to acquire EyeBio, with up to $1.7 billion more in milestones.
40%
DME patients with persistent disease activity
Share of patients still showing disease activity after six months of treatment, cited by EyeBio CEO David Guyer.
6.7%
PDR rate in remigromig 0.5mg arm
Proliferative diabetic retinopathy occurred in 6.7% of remigromig 0.5mg patients versus 0.9% with ranibizumab at one year.
$300M
Jefferies' revised peak sales estimate
Jefferies cut its risk-adjusted peak sales forecast for remigromig to $300 million from about $750 million after the BRUNELLO data.

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People Involved

DG
David Guyer
Founder, CEO, and president of EyeBio
Leading EyeBio as a wholly-owned Merck subsidiary
 Dean Y. Li
Dean Y. Li
President of Merck Research Laboratories
Overseeing remigromig's development and regulatory path
MB
Mohit Bansal
Wells Fargo analyst
Tracking Merck's ophthalmology pipeline
 Akash Tewari
Akash Tewari
Biotechnology analyst at Jefferies
Covers Merck; cut remigromig's peak sales estimate after the BRUNELLO data

Organizations Involved

Merck & Co.
Merck & Co.
Pharmaceutical company
Sponsor of remigromig development

Global pharmaceutical company developing remigromig for diabetic macular edema.
EyeBio
EyeBio
Biotechnology company
Wholly-owned Merck subsidiary; original developer of remigromig

Developer of remigromig, now advancing the drug under Merck ownership.
Roche / Genentech
Roche / Genentech
Pharmaceutical and diagnostics company
Markets ranibizumab (Lucentis), the active control in BRUNELLO

Genentech, a Roche subsidiary, sells Lucentis and the newer DME drug Vabysmo.
Jefferies
Jefferies
Investment bank
Covers Merck; cut remigromig's peak sales estimate after BRUNELLO

Investment bank whose biotechnology analysts cover Merck and the retinal disease market.

Timeline

2024 March 2027

5 events Latest: October 10th, 2026 · 1 month ago
Tap a bar to jump to that date

  1. BAROLO trial expected to complete

    Upcoming Clinical Trial

    Second pivotal Phase 2b/3 trial of remigromig in DME reaches primary completion, per ClinicalTrials.gov.

  2. Full year-one results presented at AAO

    Latest Conference Presentation

    Both remigromig doses met the primary endpoint, with BCVA gains of +9.1 and +8.7 letters versus +11.8 for ranibizumab. PDR rates were 6.7% and 6.1% versus 0.9%.

  3. Jefferies cuts remigromig peak sales forecast 60%

    Market Reaction

    Analyst Akash Tewari lowered his risk-adjusted peak sales estimate to $300 million from about $750 million, citing limited efficacy and safety data from BRUNELLO. Jefferies kept a buy rating on Merck and cut its price target to $176 from $177.

  4. BRUNELLO trial hits primary endpoint

    Clinical Trial Result

    Both remigromig doses (0.5 mg, 0.8 mg) show non-inferiority to ranibizumab on visual acuity at 52 weeks in 984 patients.

  5. Merck acquires EyeBio in $3B deal

    Acquisition

    Merck completes $1.3 billion upfront takeover of EyeBio, gaining remigromig and MK-8748.

Scenarios

1

FDA approves remigromig for diabetic macular edema

Possible Resolves by Q2 2028

Discussed by: Merck's stated intent to discuss BRUNELLO data with regulators; Wells Fargo analysts tracking the program

Merck discusses data with regulatory authorities and files a Biologics License Application once BAROLO confirms. If the safety signals from BRUNELLO don't block approval, remigromig reaches the market as the first non-VEGF mechanism for DME, positioned for patients who need a different approach. The roughly 40% of non-responders to anti-VEGF therapy are the commercial target.

2

BAROLO trial confirms remigromig's non-inferiority

Likely Resolves by May 31, 2027

Discussed by: Merck's development plan requiring a second pivotal trial; analysts assessing the DME market

The second pivotal trial, BAROLO, reaches primary completion in March 2027. If it replicates non-inferiority to ranibizumab, remigromig's efficacy story holds across two trials, strengthening Merck's filing and its commercial case against newer rivals like Vabysmo and Eylea.

3

Safety signal restricts remigromig's path

Possible Resolves by End of 2027

Discussed by: Observed imbalances in proliferative diabetic retinopathy, vitreous hemorrhage, and adverse-event discontinuations across remigromig arms

Further analyses of BRUNELLO characterize the higher rates of proliferative diabetic retinopathy and vitreous hemorrhage in remigromig patients. If the imbalance appears drug-related, the FDA could require a boxed warning, restrict the indication, or demand additional studies, delaying approval and limiting the addressable population.

4

Remigromig settles into a niche DME market

Possible Resolves by End of 2028

Discussed by: Jefferies analyst Akash Tewari, who cut his peak sales estimate to $300 million

BRUNELLO showed remigromig matched ranibizumab on vision without beating it, and PDR rates were higher. Jefferies expects the drug to be used mainly for patients who respond poorly to anti-VEGF therapy, which would keep sales far below blockbuster levels.

Historical Context

3 moments from history that rhyme with this story — and how they unfolded.

June 2006

Ranibizumab (Lucentis) transforms retinal care (2006)

The FDA approved ranibizumab for wet age-related macular degeneration, then later for DME. It replaced laser photocoagulation as the standard of care and established the anti-VEGF class of drugs that dominate retinal disease treatment today.

Then

Anti-VEGF injections became the standard for DME and wet AMD, creating a multi-billion-dollar market.

Now

A substantial share of patients plateau or lose response over time, leaving room for new mechanisms.

Why this matters now

Ranibizumab is the active control in BRUNELLO — the 2006-era standard that Wells Fargo's analyst called 'the weakest drug' in today's DME market.

November 2011

Eylea takes on Lucentis (2011)

Regeneron's aflibercept (Eylea) won FDA approval for wet AMD, showing non-inferior vision outcomes with less frequent dosing. It captured market share on convenience rather than superior efficacy.

Then

Eylea became a blockbuster and pushed Genentech to develop longer-acting rivals like Vabysmo.

Now

Non-inferiority plus better dosing proved commercially decisive; matching vision outcomes alone was not enough to win.

Why this matters now

Remigromig faces the same bar: matching ranibizumab on vision may not be enough unless it offers patients or doctors something beyond equivalence.

January 2022

Vabysmo extends the anti-VEGF frontier (2022)

Roche's faricimab (Vabysmo), a bispecific antibody blocking both VEGF-A and angiopoietin-2, won approval for DME with dosing intervals up to 16 weeks. It grew rapidly, capturing significant DME market share within two years.

Then

Vabysmo showed combination mechanisms can beat single-target drugs in the retina market.

Now

It raised the commercial bar for any new entrant, which must compete against extended dosing intervals and strong efficacy.

Why this matters now

Remigromig's Wnt pathway approach is a different bet — not extending the VEGF block, but fixing the blood-retinal barrier biology itself.

Sources

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Fierce Biotech Reuters FinancialContent (Business Wire) Merck.com StockTitan Mugglehead Biotech Insider Quartz AJMC Proactive Investors Endpoints News Merck.com Fierce Biotech