Eylea HD (high-dose aflibercept) / Regeneron, Bayer - LARVOL DELTA

Impact of faricimab and high-dose aflibercept on treatment demand in a tertiary ophthalmic centre in Norway. (PubMed, Acta Ophthalmol) - "The introduction of faricimab and high-dose aflibercept was associated with reduced per-patient treatment intensity, while the treated population continued to increase. Longer-acting anti-VEGF drugs may reduce pressure on retinal services by lowering injection frequency; however, their introduction was associated with higher overall costs."

Journal • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Aflibercept 8 mg application for macular edema following retinal vein occlusion accepted for review in China (Bayer Press Release) - "The submission to the NMPA is supported by positive results from the global randomized clinical Phase III trial QUASAR, which included patients from China."

China filing • Retinal Vein Occlusion

Real-world safety of aflibercept 8 mg in neovascular age-related macular degeneration. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "Kaplan-Meier analysis showed an IOI-free survival probability of 97.89% at 365 days, corresponding to a Kaplan-Meier-estimated cumulative incidence of 2.11% (95% CI, 1.47%-3.04%). The low frequency of newly coded IOI provides preliminary descriptive reassurance. However, the absence of an active comparator, potential outcome misclassification, and the limited event count preclude definitive conclusions regarding comparative ocular safety."

Journal • Real-world evidence • Age-related Macular Degeneration • Inflammation • Macular Degeneration • Ocular Inflammation • Ophthalmology • Retinal Disorders • Uveitis • Vasculitis • Wet Age-related Macular Degeneration

Early high-dose aflibercept 8 mg clinical outcomes in wet age-related macular degeneration patients resistant to aflibercept 2 mg or faricimab. (PubMed, Acta Ophthalmol) - No abstract available

Clinical data • Journal • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

...EYLEA HD U.S. net sales jumped 52% to $596 million... (Investing.com)

Sales • Diabetic Macular Edema • Diabetic Retinopathy • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Choroidal Changes after Intravitreal Aflibercept, Faricimab, Brolucizumab, and High-Dose Aflibercept in Treatment-Naïve Neovascular Age-Related Macular Degeneration. (PubMed, Ophthalmol Sci) - "These findings suggest drug-specific patterns of choroidal remodeling, potentially influenced by molecular and pharmacologic properties, warranting further prospective evaluation to determine their clinical implications. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article."

Journal • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Switching to Eylea HD extends injection intervals in DME patients | ASRS 2026 (Managed Healthcare Executive) - "The ILLUMIN-8 study was a retrospective analysis using the Intelligent Research in Sight (IRIS) registry. The IRIS Registry is an eye disease clinical registry developed by the American Academy of Ophthalmology...The analysis found that patients who had switched to Eylea HD gained two weeks between injections. Visual acuity for these patients was maintained during follow-up. About 30% of patients achieved 12 weeks or a longer dosing interval in this study..." "

Real-world • Diabetic Macular Edema

ASRS 2026: initiating aflibercept 8 mg or faricimab earlier improves durability and anatomic outcomes in real-world practice (Ophthalmology Times) - "The analysis included 12,501 eyes across 10,247 patients, categorized as initiators (n=1,396 eyes) who began treatment directly with aflibercept 8 mg or faricimab, or switchers (n=11,105 eyes) who transitioned from older anti-VEGF agents....Initiators achieved a mean treatment interval of 10 weeks compared with 9 weeks in switchers after transition (P <.01). Early switchers demonstrated greater durability (9.5 weeks) and substantially greater central subfield thickness (CST) reduction (−66 µm) than late switchers (9 weeks; −19 µm; P <.01). Initiators achieved a net CST reduction of −71 µm compared with −24 µm in switchers (P <.01). Best-corrected visual acuity remained stable across both groups."

Real-world • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

A Response to: Letter to the Editor Regarding "Aflibercept 8 mg Versus Faricimab Treat-and-Extend for Diabetic Macular Edema or Neovascular Age-Related Macular Degeneration: A Bayesian Fixed-Effect Network Meta-analysis of Clinical Trials". (PubMed, Ophthalmol Ther) - No abstract available

Journal • Retrospective data • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Preserved structural and functional stability of high-dose aflibercept after compounding into prefilled syringes. (PubMed, Sci Rep) - "High-dose aflibercept retains full structural and functional stability for at least 28 days after compounding into BD Microfine® or ZeroResidual® syringes when stored refrigerated. These findings support the safe use of compounded high-dose aflibercept in intravitreal injection workflows."

Journal • Cardiovascular • Macular Edema • Ophthalmology

Advances in Polypoidal Choroidal Vasculopathy (PCV) Management: Emerging Evidence for Faricimab and Aflibercept 8 mg. (PubMed, Ophthalmol Ther) - "Faricimab and aflibercept 8 mg represent important advances in PCV management, offering more durable treatment options and reducing treatment burden. However, important gaps remain, including limited real-world data for aflibercept 8 mg, absence of head-to-head PCV-specific trials, and uncertainty regarding long-term recurrence and lesion inactivation. These findings support a shift toward increasingly individualized and durable treatment strategies in PCV."

Journal • Review • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Study to Evaluate Efficacy, Safety, and Immunogenicity With ABP 938 8 mg Versus EYLEA® HD (Aflibercept) in Participants With Neovascular Age-related Macular Degeneration (clinicaltrials.gov) - P3 | N=304 | Recruiting | Sponsor: Amgen | Not yet recruiting ➔ Recruiting

Enrollment open • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

AVT29-GL-C01: Clinical Study to Compare Efficacy and Safety of AVT29 and Eylea HD in Participants with Diabetic Macular Edema (clinicaltrialsregister.eu) - P2/3 | N=172 | Recruiting | Sponsor: Alvotech Swiss AG | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetic Macular Edema • Ophthalmology

A Study to Evaluate Efficacy, Safety, and Immunogenicity With ABP 938 8 mg Versus EYLEA® HD (Aflibercept) in Participants With Neovascular Age-related Macular Degeneration (clinicaltrials.gov) - P3 | N=304 | Not yet recruiting | Sponsor: Amgen

New P3 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

…Eylea was down 20.5 percent (Fx & portfolio adj.) as a result of competitive pressure from generics (Bayer Press Release) - "The launch of Eylea 8 mg offering extended treatment intervals accounted for around 46 percent of overall Eylea sales."

Sales • Diabetic Macular Edema • Diabetic Retinopathy • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Incidence and Visual Outcomes of Endophthalmitis at a High-Volume Retina Practice: Real World Data on Faricimab and High-Dose Aflibercept (ARVO 2026) - "IVA-HD showed 0.0% in real-world use. IVF vs. IVA-HD endophthalmitis rates were not significantly different."

Clinical • Real-world • Real-world evidence • Ocular Infections • Ocular Inflammation • Ophthalmology

Phenotypic Response Patterns to Aflibercept 8 mg in Treatment-Naïve Diabetic Macular Oedema: A Pilot Cluster Analysis (ARVO 2026) - "While limited by sample size, these data support further investigation of phenotype-based individualisation and predictors of durable response with high-dose aflibercept...Most eyes improved in vision or swelling, some improved so well that they required far fewer injections, and a small number did not respond adequately. Recognising these patterns may help tailor treatment to each patient and improve long-term visual outcomes."

Diabetic Macular Edema • Macular Edema • Ophthalmology

Clinical Outcomes Following Therapy Switch from Eylea to Eylea HD (ARVO 2026) - "However, patients from certain demographics achieved a significantly longer treatment interval increase, and CFT reduction. Further studies into real life efficacy of Eylea HD and the characteristics of patients that would benefit from it are warranted."

Clinical • Clinical data • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Vascular leakage contributes causally to secondary cone degeneration in a mouse model of Retinitis Pigmentosa (ARVO 2026) - "To this end, rd1 littermates were intravitreally injected with either anti-VEGF (Eylea-HD) or PBS at P20, prior to the onset of cone degeneration. Because our findings show that reducing blood vessel leakage promotes cone survival, this indicates that this leakage may play a direct role in causing cones to degenerate. This points to a potentially new treatment strategy that targets blood vessel leakage to protect the cells essential for daylight and color vision for patients with RP."

Preclinical • Inherited Retinal Dystrophy • Ocular Inflammation • Ophthalmology • Retinal Disorders • Retinitis Pigmentosa • ALDH1A1

Prediction of VEGF suppression duration by anti-VEGF drugs with pharmacokinetic modeling (ARVO 2026) - "For an otherwise average eye with an elevated baseline VEGF concentration of 1000 pg/mL, the VEGF suppression duration was 48 days for ranibizumab, 60 days for bevacizumab, 77 days for standard-dose (2mg) aflibercept, 92 days for high-dose (8 mg) aflibercept, and 80 days for faricimab. Conclusions We generated a pharmacokinetic model that can be used as a test bed to predict the VEGF suppression durations for hypothetical anti-VEGF drugs with user-defined properties. Using the model, the impacts of various drug properties and eye-specific properties on VEGF suppression duration were elucidated."

PK/PD data • Ophthalmology

Stability of high-concentration aflibercept (114.3 mg/mL) stored for 67 days in silicone oil-free and low- siliconized syringes (ARVO 2026) - "Evidence on the long-term stability of highdose aflibercept is limited...Methods MethodsAflibercept (Eylea® 8 mg) was aseptically aliquoted into silicone oil-free and low-siliconized syringes using afully silicone oil-free transfer system...We found that the medicine stayed intact, pure, and fully functional for an extended period in both syringes. These findings provide reassurance that aflibercept can be prepared and stored in advance, helping eye clinics work more efficiently and reduce medication waste."

Ophthalmology

Endophthalmitis associated with intravitreal injection: rates, culture results, and visual acuity outcomes (ARVO 2026) - "The use of ranibizumab decreased with time in the current study while faricimab usage increased. There was a slight increase in aflibercept usage after the approval of high dose 8 mg aflibercept in 2023...The incidence of endophthalmitis after intravitreal injection did not differ between agents and did not change over time. Visual acuity outcomes were variable but frequently poor and dependent on the causative organism."

Ocular Infections • Ocular Inflammation • Ophthalmology

Real-World Comparative Analysis of Timely Versus Delayed Loading of Intravitreal high-dose Aflibercept (Eylea® 8 mg) (ARVO 2026) - "The authors conclude that short delays of a few weeks beyond the recommended schedule did not appear to harm short‑term vision, but keeping to the planned four‑week intervals is still advisable. Larger prospective studies are needed to confirm whether long‑term outcomes remain unaffected."

Clinical • Real-world • Real-world evidence • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Economic Evaluation of High-Dose Aflibercept Regimens for Neovascular Age-Related Macular Degeneration using Real World Evidence (ARVO 2026) - "Conclusions In this base-case cost-utility analysis, aflibercept 8 mg achieved modest interval extension and demonstrated cost-effectiveness over a 5-year horizon, with an ICER of $97,366 per QALY. High dose aflibercept (8 mg) therefore represents a cost-effective therapeutic option, providing comparable clinical outcomes while supporting longer injection intervals relative to alternative intravitreal regimens."

Clinical • HEOR • Real-world • Real-world evidence • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Real-World Outcomes of High Dose Aflibercept in Patients with Exudative Age-Related Macular Degeneration and Diabetic Macular Edema (ARVO 2026) - "Patients were excluded if they had less than 6 months of follow-up or received a dexamethasone intravitreal implant in the treatment eye during the course of high dose aflibercept treatment. Similarly, within the DME cohort, no statistically significant change was noted in logMAR (0.35 vs. 0.34, p=0.75) and CMT (341.4 vs. 333.0 um, p=0.56) after switching anti-VEGF agents. Conclusions Switching from a different anti-VEGF agent to high dose aflibercept was associated with increased interval length between injections for both nAMD and DME patients, suggesting increased durability of the drug compared to other agents."

Clinical • Real-world • Real-world evidence • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration