Roche presents new Phase III one-year data for vamikibart in uveitic macular edema (UME), a serious cause of vision loss
Approximately two-thirds of eligible patients required no retreatment after 16 weeks in the Phase III studies.
Sentiment and the balance of points
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Rhea-AI Summary
Roche (RHHBY) presented one-year Phase III results for investigational vamikibart in uveitic macular edema, an eye condition involving fluid buildup.
In MEERKAT and SANDCAT, a numerically higher proportion of treated patients achieved vision gains than with a sham procedure at 52 weeks. Average improvements in vision and reductions in retinal swelling were sustained. Approximately two-thirds of eligible patients required no retreatment after 16 weeks; most who needed retreatment required only one additional injection. Treatment-related eye adverse events and inflammation inside the eye occurred at low incidence.
The FDA accepted the approval application, and Roche expects an approval decision by July 2027. Regulatory submissions were also filed and accepted in the European Union, China and Japan. Acceptance does not constitute approval.
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Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Moderate pointVision gains at 52 weeks occurred in a numerically higher proportion of vamikibart-treated patients than sham-treated patients.
- Moderate pointFDA acceptance of the vamikibart approval application advances the UME regulatory review.
- Moderate pointRegulatory submissions were filed and accepted in the European Union, China and Japan.
- Minor pointAverage vision improvement from baseline was sustained at 52 weeks in both studies.
- Minor pointAverage retinal swelling reductions from baseline were sustained at 52 weeks in both studies.
3 minor points
- Minor pointRetreatment was unnecessary after 16 weeks for approximately two-thirds of eligible patients.
- Minor pointPatients needing retreatment mostly required only one additional injection.
- Minor pointTreatment-related eye adverse events and inflammation inside the eye had low incidence.
Negative
- Minor pointFDA approval remains pending; Roche expects a decision by July 2027.
AI-generated analysis. How Rhea-AI works. Not financial advice.
- In the MEERKAT and SANDCAT studies, vamikibart demonstrated sustained improvements in vision and reductions in macular thickness in patients with UME at 52 weeks1,2
- UME is the leading cause of moderate and severe vision loss in patients with uveitis, posing a significant risk of blindness if left untreated3,4
- The FDA has accepted Roche's Biologics License Application (BLA), with an approval decision expected by July 2027
Basel, 10 October 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today new one-year data from the Phase III MEERKAT and SANDCAT studies evaluating investigational vamikibart compared with a sham procedure that mimics intravitreal (IVT) injections in adults with uveitic macular edema (UME). Across both studies, data continue to support the potential for rapid and sustained improvements in vision and reductions in macular thickness (swelling in the back of the eye due to retinal fluid) with vamikibart treatment. The data were presented at the American Academy of Ophthalmology 2026 Annual Meeting (AAO 2026) in New Orleans, LA.1
Additionally, the U.S. Food and Drug Administration (FDA) has accepted Roche’s Biologics License Application (BLA) for vamikibart for the treatment of UME. The filing acceptance is based on the results from the MEERKAT and SANDCAT studies. The FDA is expected to make a decision on approval by July 2027. If approved, vamikibart would be the first non-steroid targeted treatment for UME, with potential to establish a new standard of care. Regulatory submissions have also been filed and accepted in the European Union, China and Japan.
“These one-year results strengthen vamikibart’s clinical profile, confirming that initial visual and anatomical improvements are maintained over 52 weeks,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “The acceptance of our application by the FDA and other regulatory bodies around the world brings us closer to offering a transformative, non-steroid therapy for people living with this sight-threatening condition.”
“Currently, UME is commonly treated with off-label therapies or ocular steroids, the latter carrying significant long-term side effects like glaucoma and cataract formation,” said Nisha Acharya, M.D., M.S., Distinguished Professor of Ophthalmology at UCSF and Director of the Uveitis and Ocular Inflammatory Disease Service. “Vamikibart is the first non-steroid targeted therapy to demonstrate meaningful and sustained visual and anatomical improvements in people with UME, offering a potential new treatment option that directly targets the inflammation driving this sight-threatening condition.”
The 16-week primary analysis results were presented at the AAO meeting in October 2025.2 In both MEERKAT and SANDCAT at 52 weeks, a numerically higher proportion of vamikibart-treated patients achieved vision gains compared to sham treatment on the primary endpoint. Key secondary endpoints showed this benefit was maintained, with sustained 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. Vamikibart demonstrated durable clinical benefit with a low treatment burden: approximately two-thirds of eligible patients required no retreatment after 16 weeks, while the majority of those who did required only one additional injection. Vamikibart was well tolerated, maintaining a favourable safety profile, with a low incidence of treatment-related ocular adverse events (AEs) and intraocular inflammation (IOI) events.1
UME is the leading cause of moderate-to-severe vision loss in individuals with uveitis, predominantly affecting working-age adults.3,4 Approximately
About the MEERKAT and SANDCAT studies
MEERKAT (NCT05642312) and SANDCAT (NCT05642325) are identical Phase III, global, parallel, multicentre, randomised, double-masked, sham comparator-controlled, 52-week trials of intravitreal (IVT) vamikibart in uveitic macular edema (UME). In both trials, patients were randomised and received treatment every four weeks with either 0.25 mg vamikibart, 1 mg vamikibart or sham IVT injection, for up to 16 weeks, followed by PRN treatment through week 52. The primary endpoint of both Phase III trials was the proportion of participants with a 15 letter or more improvement from baseline in best corrected visual acuity (BCVA) at week 16. Key secondary endpoints included the average change from baseline in BCVA and CST at week 16. The safety of vamikibart was assessed through adverse events (AEs) such as treatment related ocular AEs, intraocular inflammation (IOI) and retinal occlusive vasculitis. The studies included participants with and without prior IVT treatment history and included patients with history of raised IOP and glaucoma.2,13,14
About uveitic macular edema (UME)
UME is characterised by the buildup of fluid in the macula due to uveitis, an inflammatory eye condition.3 Although rare compared to other eye diseases, UME has a disproportionate impact on vision loss and blindness globally.3,15-20 It is the leading cause of moderate and severe vision loss in people with uveitis, and the most frequent sight threatening complication in uveitis.17-22 Uveitis accounts for
About vamikibart
Vamikibart is an investigational monoclonal antibody that has been specifically engineered for IVT administration.1,2,12 It targets interleukin-6 (IL-6), a key cytokine in the inflammatory pathway in UME.1,2,12 In the Phase I DOVETAIL study, vamikibart provided rapid vision improvements and resolution of macular edema in people with UME.12 Vamikibart was also well tolerated, with no treatment-related serious adverse events reported.12 Based on the promising Phase I DOVETAIL data, Roche initiated the two identical Phase III vamikibart studies MEERKAT and SANDCAT.1,2,12 Vamikibart is being investigated in retinal diseases with recognised inflammatory pathways. Vamikibart has orphan drug designation in the United States and European Union.
About Roche in Ophthalmology
At Roche, we are on a mission to save and restore eyesight. Over 330 million people around the world are blind, or living with vision loss, creating a profound personal and socioeconomic burden. With the broadest pipeline in Ophthalmology, we continue to invest at scale to redefine what is medically possible in eye care.
Our comprehensive ophthalmology pipeline integrates diverse targets, advanced delivery systems, cell and gene therapies, and AI-augmented imaging capabilities, targeting multiple vision-threatening conditions, including retinal vascular and diabetic eye diseases, geographic atrophy, and autoimmune conditions, such as thyroid eye disease and uveitic macular edema.
About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.
Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.
Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.
For more information, please visit www.roche.com.
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References
[1] Acharya N, et al. Vamikibart for Uveitic Macular Edema: Week 52 Efficacy and Safety Results From the Phase 3 MEERKAT and SANDCAT Trials. Presented at: the American Academy of Ophthalmology Annual Meeting (AAO 2026); 2026 October 10; New Orleans, Louisiana, United States.
[2] Khurana RN, et al. Efficacy and Safety of Vamikibart in Patients With Uveitic Macular Edema: First Report of Phase 3 MEERKAT/SANDCAT Trials. Presented at: the American Academy of Ophthalmology Annual Meeting (AAO 2025); 2025 October 17; Orlando, Florida, United States.
[3] Massa H, Pipis SY, Adewoyin T, Vergados A, Patra S, Panos GD. Macular edema associated with non-infectious uveitis: pathophysiology, etiology, prevalence, impact and management challenges. Clin Ophthalmol. 2019;13:1761-1777. doi:10.2147/OPTH.S180580
[4] Jones NP, Pradeep A, John B. Certification of vision impairment in patients with uveitis attending a specialist clinic. Ocul Immunol Inflamm. 2019;27(4):540-544. doi:10.1080/09273948.2018.1441874
[5] Do BK, et al. Visual Outcomes by Age and Sex in Uveitic Macular Edema: Real-World Retina Registry Analysis. Presented at: the 44th Annual Meeting of the American Society of Retinal Specialists; 2026 July 15–18; Montréal, Canada.
[6] Rosenbaum JT, Bodaghi B, Couto C, et al. New observations and emerging ideas in diagnosis and management of non-infectious uveitis: A review. Semin Arthritis Rheum. 2019;49(3):438-445. doi:10.1016/j.semarthrit.2019.06.004
[7] Leandro L, Beare N, Bhan K, et al. Systemic corticosteroid use in UK Uveitis practice: results from the ocular inflammation steroid toxicity risk (OSTRICH) study. Eye. 2021;35(12):3342-3349. doi:10.1038/s41433-020-01336-6
[8] Nguyen QD, Hatef E, Kayen B, et al. A Cross-sectional Study of the Current Treatment Patterns in Noninfectious Uveitis among Specialists in the United States. Ophthalmology. 2011;118(1):184-190. doi:10.1016/j.ophtha.2010.03.029
[9] Fini ME, Schwartz SG, Gao X, et al. Steroid-induced ocular hypertension/glaucoma: Focus on pharmacogenomics and implications for precision medicine. Prog Retin Eye Res. 2017;56:58-83. doi:10.1016/j.preteyeres.2016.09.003
[10] Sen HN, Vitale S, Gangaputra SS, et al. Periocular Corticosteroid Injections in Uveitis: Effects and Complications. Ophthalmology. 2014;121(11):2275-2286. doi:10.1016/j.ophtha.2014.05.021
[11] Rice JB, White AG, Scarpati LM, Wan G, Nelson WW. Long-term Systemic Corticosteroid Exposure: A Systematic Literature Review. Clinical Therapeutics. 2017;39(11):2216-2229. doi:10.1016/j.clinthera.2017.09.011
[12] Sharma S, Lin P, Hu A, et al. Interleukin 6 Inhibition With Vamikibart for Uveitic Macular Edema: The Phase 1 DOVETAIL Nonrandomized Clinical Trial. JAMA Ophthalmol. 2026;144(5):442-451. doi:10.1001/jamaophthalmol.2026.0610
[13] Hoffmann-La Roche. A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Vamikibart Administered Intravitreally in Patients With Uveitic Macular Edema. clinicaltrials.gov; 2025. Accessed September 17, 2026. https://clinicaltrials.gov/study/NCT05642312
[14] Hoffmann-La Roche. A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Vamikibart Administered Intravitreally in Patients With Uveitic Macular Edema. clinicaltrials.gov; 2026. Accessed September 17, 2026. https://clinicaltrials.gov/study/NCT05642325
[15] Teper SJ. Update on the Management of Uveitic Macular Edema. J Clin Med. 2021;10(18):4133. doi:10.3390/jcm10184133
[16] Fardeau C, Champion E, Massamba N, LeHoang P. Uveitic macular edema. Eye. 2016;30(10):1277-1292. doi:10.1038/eye.2016.115
[17] Smith JR, Thorne JE, Flaxel CJ, et al. Treatment of Noninfectious Uveitic Macular Edema with Periocular and Intraocular Corticosteroid Therapies: A Report by the American Academy of Ophthalmology. Ophthalmology. 2024;131(9):1107-1120. doi:10.1016/j.ophtha.2024.02.019
[18] Sood G, Patel BC. Uveitic Macular Edema. In: StatPearls. StatPearls Publishing; 2023. Accessed September 17, 2026. http://www.ncbi.nlm.nih.gov/books/NBK562158/
[19] Tomkins-Netzer O, Lightman SL, Burke AE, et al. Seven-Year Outcomes of Uveitic Macular Edema: The Multicenter Uveitis Steroid Treatment Trial and Follow-up Study Results. Ophthalmology. 2021;128(5):719-728. doi:10.1016/j.ophtha.2020.08.035
[20] Matas J, Llorenç V, Fonollosa A, et al. Systemic Regulatory T Cells and IL-6 as Prognostic Factors for Anatomical Improvement of Uveitic Macular Edema. Front Immunol. 2020;11:579005. doi:10.3389/fimmu.2020.579005
[21] Tomkins-Netzer O, Talat L, Bar A, et al. Long-Term Clinical Outcome and Causes of Vision Loss in Patients with Uveitis. Ophthalmology. 2014;121(12):2387-2392. doi:10.1016/j.ophtha.2014.07.007
[22] Tallouzi MO, Moore DJ, Bucknall N, et al. Outcomes important to patients with non-infectious posterior segment-involving uveitis: a qualitative study. BMJ Open Ophth. 2020;5(1):e000481. doi:10.1136/bmjophth-2020-000481
[23] Cunningham ET, Zierhut M. Vision Loss in Uveitis. Ocular Immunology and Inflammation. 2021;29(6):1037-1039. doi:10.1080/09273948.2021.2017152
[24] Tomkins-Netzer O, Lightman S, Drye L, et al. Outcome of Treatment of Uveitic Macular Edema: The Multicenter Uveitis Steroid Treatment Trial 2-Year Results. Ophthalmology. 2015;122(11):2351-2359. doi:10.1016/j.ophtha.2015.07.036
[25] Frick KD, Drye LT, Kempen JH, et al. Associations among Visual Acuity and Vision- and Health-Related Quality of Life among Patients in the Multicenter Uveitis Steroid Treatment Trial. Invest Ophthalmol Vis Sci. 2012;53(3):1169. doi:10.1167/iovs.11-8259
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Attachment
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did Roche's one-year vamikibart studies show for uveitic macular edema?
At 52 weeks, MEERKAT and SANDCAT showed a numerically higher proportion of vamikibart-treated patients achieving vision gains than sham-treated patients. Average vision improvements and reductions in retinal swelling were sustained.
When is the FDA decision on Roche's vamikibart expected?
Roche expects an FDA approval decision for vamikibart in uveitic macular edema by July 2027. The FDA has accepted the approval application based on the MEERKAT and SANDCAT results.
What was the primary endpoint in Roche's MEERKAT and SANDCAT vamikibart trials?
The primary endpoint was the proportion of participants achieving a 15 letter or more improvement from baseline in best corrected visual acuity at week 16. This measures vision with corrective lenses. The trials also assessed average changes from baseline in vision and central retinal thickness at week 16.
How was vamikibart administered in Roche's Phase III UME trials?
Patients were randomly assigned to 0.25 mg vamikibart, 1 mg vamikibart or a sham injection every four weeks for up to 16 weeks, followed by treatment as needed through week 52. Vamikibart was injected into the eye; the sham procedure mimicked that injection.
Which patients were included in Roche's Phase III vamikibart trials?
The studies included participants with and without prior injections into the eye, including patients with a history of raised eye pressure and glaucoma. Both trials were global, randomised, double-masked studies, meaning participants and investigators were unaware of treatment assignments.