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Kodiak Sciences announced that Zenkuda and tabirafusp-ted achieved noninferiority to Regeneron's aflibercept in vision gains in the Phase 3 DAYBREAK study for wet age-related macular degeneration. Zenkuda showed durability allowing over half of patients to reach six-month dosing intervals, and Kodiak plans to file a biologics license application in late 2026 covering three retinal disease indications.

Editor’s note: This is a developing news story. Please check back soon for updates. Yesafili, an interchangeable biosimilar to Eylea 2 mg, is now commercially available in the United States, according to a press release from Biocon. The FDA approved Yesafili (aflibercept-jbvf) in May 2024. It is indicated for neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy. In the phase 3 INSIGHT study, researchers compared Yesafili with Eylea 2 mg (aflibercept, Regeneron) in patients with DME. There were no differences

Eye, Published online: 10 July 2026; doi:10.1038/s41433-026-04663-2Author Correction: Sustainability in medical retina: the environmental impact of using aflibercept 8 mg instead of aflibercept 2 mg in treatment-naïve patients with nAMD

Editor’s note: This is a developing news story. Please check back soon for updates. Two investigational agents from Kodiak Sciences helped improve vision in patients with wet age-related macular degeneration, according to a press release. In the phase 3 DAYBREAK study, researchers assessed Zenkuda (tarcocimab tedromer) and KSI-501 (tabirafusp alfa tedromer) vs. Eylea (aflibercept, Regeneron) in patients wet AMD. Zenkuda is an anti-VEGF that uses Kodiak’s antibody biopolymer conjugate (ABC) platform and is designed to maintain more durable drug levels. KSI-501 is an anti-IL-6, VEGF-trap

Eye, Published online: 13 January 2025; doi:10.1038/s41433-024-03543-xInfographic: Efficacy and safety of high-dose Intravitreal aflibercept 8 mg in patients with neovascular age-related macular degeneration: week 48 results from the phase 3 PULSAR trial

On November 12, 2025, Regeneron filed a Motion to Strike Certain Affirmative Defenses and Dismiss Certain Counterclaims against Amgen in the aflibercept patent litigation in the U.S. District Court fo...

Comparison of discharge & readmission rates between Faricimab & aflibercept in UK patients with nAMD, whilst stratifying these rates by lesion type.

Age-related macular degeneration (AMD) is one of the leading causes of central retinal blindness. Here, Campbell and colleagues show that transplanted retinal pigment epithelial cells can be engineere...

Background/aims To evaluate real-world, short-term anatomical and functional outcomes of faricimab versus aflibercept 2 mg in diabetic macular oedema (DMO).Methods This retrospective, parallel-cohort comparative study included 300 consecutive patients with DMO from Moorfields Eye Hospital. Eligible eyes were treatment-naïve and treatment-experienced not receiving therapy for ≥6 months and subsequently initiated on loading phase of faricimab or aflibercept 2mg. Follow-up was 4 months. Data were collected from the Moorfields electronic medical records system. Changes in visual acuity (VA) and central subfield thickness (CST) from baseline to the fourth injection were analysed using multiple linear regression adjusted for baseline covariates (age, gender, ethnicity, diabetes type, baseline retinopathy status, baseline VA or CST and treatment interval).Results Of 300 eyes enrolled, 292 were ultimately analysed (191 aflibercept; 101 faricimab), with 246 eyes (84.2%) completing follow-up. Mean unadjusted VA gain was +3.9±10.4 letters with aflibercept and +5.2±11.8 letters with faricimab. Adjusted marginal mean VA gain was +4.2 letters for aflibercept and +4.7 letters for faricimab, with a non-significant difference of –0.5 letters (p=0.7). Baseline VA and treatment interval were significant predictors of functional response, with baseline VA exerting approximately 3.4 times the impact of treatment interval. Mean CST reduction was 87.3±106.1 µm with aflibercept and 113.1±136.7 µm with faricimab. Adjusted mean reductions were 95.4 µm and 99.8 µm, respectively (difference –4.4 µm, p=0.7). Baseline CST was the only independent predictor of anatomical response.Conclusion Faricimab and aflibercept achieved comparable short-term anatomical and functional outcomes, with greater anatomical improvement associated with higher baseline CST and larger visual gains observed with lower baseline VA. Treatment interval influenced functional response, underscoring the importance of timely therapy. Baseline disease features and treatment adherence are key determinants of early outcomes, rather than drug selection.

Objective Biosimilars are helping to reduce the cost burden of treatment and widen patient access to therapies. This multicentre trial compared the efficacy, safety and immunogenicity of the biosimilar aflibercept FYB203 with reference aflibercept in patients with neovascular age-related macular degeneration (nAMD). Methods and analysis Patients aged ≥50 years with newly diagnosed nAMD and a best-corrected visual acuity (BCVA) between 20/40 and 20/200 Snellen equivalent were randomised (1:1) to double-masked treatment with 2 mg FYB203 or EU-approved reference aflibercept by intravitreal injection every 4 weeks for three doses (baseline, weeks 4 and 8) then every 8 weeks up to week 48. The primary efficacy endpoint was the change from baseline in BCVA by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 8 in the study eye. Therapeutic equivalence of FYB203 and reference aflibercept was demonstrated if, depending on the regulatory requirement with respect to the significance level, the two-sided 90.4% and 95.2% CIs were within the predefined equivalence interval of (–3.5 to 3.5) ETDRS letters. Results A total of 433 patients received treatment with FYB203 (n=215) or reference aflibercept (n=218). Mean improvement in BCVA from baseline to week 8 was 6.6 ETDRS letters with FYB203 and 5.6 ETDRS letters with reference aflibercept, with an estimated mean treatment difference of 1.0 and the two-sided 90.4% CI (–0.3 to 2.2) and 95.2% CI (–0.6 to 2.5) fully contained within the pre-defined equivalence margins, confirming therapeutic equivalence between FYB203 and reference aflibercept. Safety and immunogenicity profiles were similar between groups. Conclusion Although conducted during the COVID-19 pandemic in a potentially vulnerable elderly population and affected by geopolitical disruption in Ukraine, mitigation measures minimised the overall impact of these events. FYB203 demonstrated therapeutic equivalence to reference aflibercept in patients with nAMD, supporting similar clinical performance across all approved indications. Trial registration number Clinicaltrials.gov: NCT04522167; EudraCT: 2019-003923-39.

Eye, Published online: 21 September 2026; doi:10.1038/s41433-026-04864-9Clustered sterile intraocular inflammation following intravitreal aflibercept injections: involvement of 2 mg, 8 mg, and biosimilar formulations

Results of a registry analysis on the real-world use of aflibercept 8 mg in treatment-naive and previously treated eyes with diabetic macular edema were presented at the American Society of Retina Specialists annual meeting. “This is a registry study [on Eylea HD (aflibercept 8 mg, Regeneron)], so we don’t have individual patient-level data, and unfortunately, at this time, we don’t have the ability to look at the OCTs, but this, to me, is quite helpful in my day-to-day decision-making” Sunir J. Garg, MD, FACS, FASRS, chief of the retina service at Wills Eye Hospital and professor of

Eye, Published online: 04 August 2026; doi:10.1038/s41433-026-04710-yReal-world comparative effectiveness of faricimab versus aflibercept 2 mg in treatment-naïve exudative neovascular AMD patients treated with a treat-and-extend regimen

Background/aims To compare fluctuations of central subfield retinal thickness (CSRT) in patients with neovascular age-related macular degeneration undergoing ranibizumab pro re nata versus aflibercept bimonthly treatment in a prospective 12 month, phase IV, randomised, multicentre study. Methods Ranibizumab was administered according to best-corrected visual acuity (BCVA) and/or disease activity detected on spectral domain optical coherence tomography. Aflibercept was administered at three initial monthly visits followed by bimonthly treatment. CSRT stability was evaluated between months 3 and 6. CSRT stability was compared between groups and correlated with functional outcomes at month 12. Results Fluctuations of CSRT showed a least-squares (LS) mean (95% CI) difference of –4.12 (–10.22 to 1.98) µm between ranibizumab (25.16 (20.09 to 30.24) µm) and aflibercept groups (29.28 (24.14 to 34.43) µm) (p=0.1850). A predefined analysis of retinal stability, adjusted for baseline CSRT, showed a LS mean (95% CI) difference of –6.53 (–12.47 to –0.58 µm) in favour of ranibizumab (23.53 (18.58 to 28.49) µm) versus aflibercept (30.06 (25.04 to 35.07) µm) (p=0.0315). Pearson’s correlation coefficient demonstrated no correlation between the mean amplitude of CSRT fluctuation between months 3 and 6, and BCVA at month 12 (r = –0.0888). Adverse event rates were low. Conclusions Numerical differences in retinal thickness fluctuations between months 3 and 6 were detected between treatment regimens. While the presence of fluctuations has previously been shown to have a negative impact on functional outcomes, our data showed no correlation between the mean amplitude of fluctuations and functional outcomes at month 12.

Kodiak Sciences informó el 28 de septiembre de 2026 que sus dos tratamientos experimentales para la degeneración macular húmeda relacionada con la edad cumplieron el objetivo principal del ensayo DAYBREAK de fase 3. Zenkuda y KSI-501 lograron resultados de agudeza visual no inferiores a los de Eylea (aflibercept) al cabo de aproximadamente un año, según los resultados iniciales difundidos por la empresa. Las acciones de Kodiak cerraron ese lunes con una subida de casi 178%, mientras la compañía prepara una solicitud de aprobación para Zenkuda en Estados Unidos. ## El intervalo de seis meses se alcanzó en 54% de los tratados con Zenkuda La cifra que puede cambiar la frecuencia de las inyecciones corresponde a Zenkuda: 54% de quienes lo recibieron alcanzó un intervalo de seis meses entre dosis al primer año, de acuerdo con Kodiak. El tratamiento comenzó con cuatro dosis mensuales y después se ajustó entre cuatro y 24 semanas según la presencia de líquido en la retina. Eso no significa que todos los pacientes puedan pasar medio año sin una nueva inyección. DAYBREAK comparó por separado Zenkuda y KSI-501 con un grupo de referencia tratado con aflibercept. Ambos brazos experimentales cumplieron el criterio de no inferioridad en visión; ese resultado indica que alcanzaron el margen fijado por el ensayo frente al comparador, pero no demuestra que mejoren más la vista. KSI-501 también actúa sobre la interleucina 6, relacionada con procesos inflamatorios, además de bloquear VEGF. Kodiak planea analizar si ciertos grupos de pacientes obtienen un beneficio adicional de ese mecanismo. La enfermedad afecta la visión central. El Instituto Nacional del Ojo de Estados Unidos explica que los tratamientos anti-VEGF suelen requerir inyecciones repetidas. Por eso, el intervalo observado con Zenkuda puede importar para la carga de tratamiento. El 54% describe lo ocurrido dentro del ensayo durante el primer año; no permite predecir qué proporción podrá mantener esa pauta en la práctica clínica. ## La solicitud regulatoria aún está pendiente Kodiak planea presentar ante la FDA una solicitud de licencia biológica para Zenkuda en el cuarto trimestre de 2026, apoyada en cinco ensayos de fase 3 para tres enfermedades de la retina. La compañía comunicó resultados iniciales de DAYBREAK; presentar la solicitud y obtener autorización son pasos distintos. Ni Zenkuda ni KSI-501 están aprobados para su comercialización. El mercado reaccionó antes de esa revisión: las acciones de Kodiak terminaron la sesión del 28 de septiembre en 89.92 dólares, un avance de 177.96% frente al cierre previo, según Stock Analysis. La cifra bursátil mide la reacción de los inversionistas al anuncio, mientras que el posible cambio para los pacientes depende de la evaluación regulatoria de la eficacia, seguridad y pauta de dosificación. _Fuentes:_ 1, 2, 3