vamikibart (RG6179) / Roche - LARVOL DELTA

First report of the baseline characteristics of participants with uveitic macular edema in the vamikibart phase 3 MEERKAT and SANDCAT trials (ARVO 2026) - P3 | "Conclusions The heterogeneous and diverse participants enrolled in the MEERKAT/SANDCAT trials had chronic, active UME and vision loss, despite frequent use of systemic immunosuppression. These baseline data highlight a significant unmet need in UME, and this population is relevant for vamikibart evaluation."

P3 data • Glaucoma • Macular Edema • Ocular Inflammation • Ophthalmology • Retinal Disorders • Uveitis • IL6

Vamikibart Filed for Regulatory Approval in Japan for Uveitic Macular Edema Associated with Non-Infectious Uveitis (Chugai Press Release) - "Vamikibart was granted orphan drug designation by the Ministry of Health, Labour and Welfare for this indication on June 23, 2026....This filing is based on results from the global Phase III MEERKAT and SANDCAT studies, among others, in patients with uveitic macular edema associated with non-infectious uveitis."

Japan filing • Orphan drug • Macular Edema • Uveitis

Efficacy and safety of vamikibart in patients with uveitic macular edema: anatomical outcomes at Week 16 in the phase 3 MEERKAT and SANDCAT trials (ARVO 2026) - P3 | "Conclusions Vamikibart, a novel IVT anti–IL-6 therapy, demonstrated efficacy in anatomical and vision outcomes, and was well tolerated in patients with UME. Vamikibart is a non-steroid treatment that directly targets macular edema due to ocular inflammation."

Clinical • P3 data • Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis

The Effect of Intraocular Inhibition of Interleukin-6 on Retinal Inflammation and Vascular Leakage in an Experimental Autoimmune Uveitis Model (ARVO 2026) - "Conclusions Intravitreal IL-6 inhibition effectively attenuates retinal inflammation and vascular leakage in EAU by suppressing downstream inflammatory cytokines and adhesion molecule expression. These findings support the potential of vamikibart as a therapeutic strategy for UME."

Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis • ICAM1 • IFNG • IL17A • IL6 • SELP • TNFA • VCAM1

The molecular pathophysiology of uveitic macular edema: an exploratory analysis from the DOVETAIL vamikibart phase 1 study (ARVO 2026) - P1 | "Conclusions These findings demonstrate the significant upregulation of IL-6 and multiple related downstream signaling proteins within the aqueous humor of patients with UME. This molecular signature provides a robust scientific rationale for the localized targeting of IL-6 as a novel therapeutic strategy in UME."

P1 data • Cataract • Diabetic Macular Edema • Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis • CCL19 • CCL8 • ICAM1 • IL6R • MMP9 • VCAM1

Efficacy and safety of vamikibart in combination with ranibizumab in patients with DME: first results from the phase 2 BARDENAS trial (ARVO 2026) - P2 | "These findings build upon the ALLUVIUM vamikibart monotherapy trial and suggest that IL-6 inhibition exerts a clinical effect distinct from VEGF blockade. Thus, BARDENAS provides a rationale for exploring combination therapy with anti-IL-6 and anti-VEGF to address the multiple pathogenic pathways that drive DME, with potentially better results."

Clinical • Combination therapy • P2 data • Cataract • Diabetic Macular Edema • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders

Efficacy and safety of vamikibart in patients with diabetic macular edema: first results from the phase 2 ALLUVIUM trial (ARVO 2026) - P2 | "Purpose Interleukin-6 (IL-6) is a key inflammatory cytokine elevated in ocular fluids of patients with diabetic macular edema (DME). Although efficacy was less robust than ranibizumab, these findings suggest that IL-6 inhibition provides a clinical effect distinct from vascular endothelial growth factor (VEGF) blockade. This study provides a rationale for exploring the combination of anti-IL-6 and anti-VEGF to simultaneously target both inflammatory and angiogenic pathways in DME."

Clinical • P2 data • Cataract • Diabetic Macular Edema • Ophthalmology

MEERKAT and SANDCAT: Vamikibart vs sham in uveitic macular edema (Ophthalmology Times) - "In MEERKAT and SANDCAT, respectively, mean CST change from baseline was −187.5/−209.7 μm with vamikibart 0.25 mg and −196.1/−194.7 μm with vamikibart 1.0 mg, versus −58.5/−43.5 μm with sham. The proportion of patients achieving UME resolution (CST below 325 μm) was 56.7/63.3% with 0.25 mg and 61.2/57.3% with 1.0 mg, versus 16.3/18.0% with sham. The proportion of patients achieving a ≥15-letter improvement in BCVA was 26.1/34.0% with 0.25 mg and 43.2/24.2% with 1.0 mg, versus 6.3/13.3% with sham. Mean BCVA change from baseline was +9.6/+11.9 letters with 0.25 mg and +12.8/+9.2 letters with 1.0 mg, versus +3.5/+5.0 letters with sham."

P3 data • Diabetic Macular Edema • Uveitis

ALLUVIUM: Vamikibart monotherapy vs ranibizumab in DME (Ophthalmology Times) - "Adjusted mean BCVA change from baseline at weeks 44/48 was +7.1, +4.6, and +5.5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters for vamikibart 0.25 mg Q8W, 1.0 mg Q8W, and 1.0 mg Q4W, respectively, compared with +13.0 letters for ranibizumab. The proportion of patients achieving a ≥15-letter gain in BCVA was 14.9%, 22.9%, and 15.6% across the vamikibart dose groups versus 40.0% for ranibizumab. Mean central subfield thickness (CST) reduction was −68.4, −50.8, and −67.5 μm for vamikibart doses versus −174.2 μm for ranibizumab...Higher rates of adverse events related to intraocular inflammation were observed with vamikibart compared with ranibizumab; rates of cataract and elevated intraocular pressure (IOP) were comparable between groups."

P2 data • Diabetic Macular Edema

BARDENAS: Vamikibart plus ranibizumab vs ranibizumab alone in DME (Ophthalmology Times) - "Adjusted mean BCVA change from baseline at weeks 44/48 was +12.8 letters for VAM+RBZ versus +9.4 letters for ranibizumab, meeting the pre-established nominal significance level of P = .1 (P = .063). The proportion of patients achieving a ≥15-letter gain in BCVA was 44.7% for VAM+RBZ versus 28.6% for ranibizumab. Mean CST reduction was −202.4 μm for VAM+RBZ versus −192.4 μm for ranibizumab. The proportion of patients achieving CST below 325 μm at weeks 44/48 was 85.1% for VAM+RBZ versus 71.4% for ranibizumab."

P2 data • Diabetic Macular Edema

Roche to present extensive data showcasing its industry-leading ophthalmology portfolio at ARVO 2026 (Roche Press Release) - "The data being presented emphasise Roche’s focus on preserving vision through innovative therapies, including Vabysmo (faricimab), Susvimo (Port Delivery Platform with ranibizumab) and the investigational interleukin-6 (IL-6) inhibitor, vamikibart. The data cover five retinal conditions including geographic atrophy (GA), retinal vein occlusion (RVO) and uveitic macular edema (UME) as well as diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD)."

Clinical data • Diabetic Macular Edema • Macular Edema • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Interleukin 6 Inhibition With Vamikibart for Uveitic Macular Edema: The Phase 1 DOVETAIL Nonrandomized Clinical Trial. (PubMed, JAMA Ophthalmol) - P1, P3 | "Two phase 3 clinical trials (MEERKAT [NCT05642312] and SANDCAT [NCT05642325]) are underway to further evaluate vamikibart in UME. ClinicalTrials.gov Identifier: NCT06771271."

Clinical • Journal • P1 data • Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis • Vasculitis • IL6

Vamikibart in Participants With Uveitic Macular Edema (clinicaltrials.gov) - P3 | N=256 | Completed | Sponsor: Hoffmann-La Roche | Active, not recruiting ➔ Completed

Trial completion • Macular Edema • Ophthalmology • Uveitis

Genentech…announced…results from two Phase III studies evaluating the efficacy and safety of two doses of investigational vamikibart (0.25 and 1 mg) compared with a sham procedure that mimics intravitreal (IVT) injections in people with uveitic macular edema (UME). (Genentech Press Release) - "In both trials, a numerically higher proportion of patients treated with vamikibart gained vision, with primary endpoint data demonstrating statistically significant superiority over sham in MEERKAT, though not in SANDCAT. Consistently across both trials, key secondary endpoints showed rapid and clinically meaningful improvements in average change from baseline in best corrected visual acuity (BCVA), and average change from baseline in central subfield thickness (CST), a key measure of macular edema, supporting the overall efficacy profile of vamikibart."

P3 data • Macular Edema

A Study to Investigate Vamikibart in Participants With Uveitic Macular Edema (clinicaltrials.gov) - P3 | N=245 | Completed | Sponsor: Hoffmann-La Roche | Active, not recruiting ➔ Completed

Trial completion • Macular Edema • Ophthalmology • Uveitis

A Study to Investigate Vamikibart (RO7200220) in Diabetic Macular Edema (clinicaltrials.gov) - P2 | N=394 | Completed | Sponsor: Hoffmann-La Roche | Active, not recruiting ➔ Completed

Trial completion • Diabetic Macular Edema • Ophthalmology

Vamikibart in Participants With Uveitic Macular Edema (clinicaltrials.gov) - P3 | N=256 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial primary completion date: Dec 2025 ➔ May 2025

Trial primary completion date • Macular Edema • Ophthalmology • Uveitis

Intravitreal IL-6 inhibition with vamikibart in uveitic macular edema (UME): baseline characteristics of the DOVETAIL phase 1 study (ARVO 2025) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

P1 data • Diabetic Macular Edema • Macular Edema • Ocular Inflammation • Ophthalmology • Retinal Disorders • Uveitis

Real-world treatment patterns in patients with macular edema (ME) due to noninfectious uveitis (NIU) in the United States (ARVO 2025) - "Two ongoing global randomized, controlled, identically designed, phase 3 studies are investigating vamikibart, an IVT anti–IL-6 MAB, in NIU with UME. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • HEOR • Real-world • Real-world evidence • Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis

DOVETAIL: A Study to Investigate RO7200220 as Monotherapy and in Combination With Ranibizumab in Participants With Diabetic and Uveitic Macular Edema (clinicaltrials.gov) - P1 | N=85 | Completed | Sponsor: Hoffmann-La Roche

Monotherapy • New P1 trial • Diabetic Macular Edema • Macular Edema • Ophthalmology

Vamikibart in Participants With Uveitic Macular Edema (clinicaltrials.gov) - P3 | N=256 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2025 ➔ Dec 2025 | Trial primary completion date: Jun 2025 ➔ Dec 2025

Enrollment closed • Trial completion date • Trial primary completion date • Macular Edema • Ophthalmology • Uveitis

A Study to Investigate Vamikibart in Participants With Uveitic Macular Edema (clinicaltrials.gov) - P3 | N=245 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial primary completion date: Jun 2025 ➔ Dec 2024

Trial primary completion date • Macular Edema • Ophthalmology • Uveitis

A Study to Investigate Vamikibart (RO7200220) in Combination With Ranibizumab in Diabetic Macular Edema (clinicaltrials.gov) - P2 | N=187 | Completed | Sponsor: Hoffmann-La Roche | Active, not recruiting ➔ Completed

Combination therapy • Trial completion • Diabetic Macular Edema • Ophthalmology

A Study to Investigate Vamikibart in Participants With Uveitic Macular Edema (clinicaltrials.gov) - P3 | N=225 | Recruiting | Sponsor: Hoffmann-La Roche | Active, not recruiting ➔ Recruiting

Enrollment open • Macular Edema • Ophthalmology • Uveitis

A Study to Investigate Vamikibart in Participants With Uveitic Macular Edema (clinicaltrials.gov) - P3 | N=225 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting

Enrollment closed • Macular Edema • Ophthalmology • Uveitis