Eylea (aflibercept intravitreal) / Bayer, Regeneron - LARVOL DELTA

A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macular Edema (clinicaltrials.gov) - P1/2 | N=153 | Completed | Sponsor: Opthea Limited | Phase classification: P1b/2a ➔ P1/2

Phase classification • Diabetic Macular Edema • Ophthalmology

OCT predictors of retinal atrophy in neovascular age-related macular degeneration treated with aflibercept. (PubMed, Int J Ophthalmol) - "Type 2 MNV, reduces ONL and CFT, and IRF presence at baseline may signal a higher risk of RA in treatment-naive nAMD patients, underscoring the importance of these OCT features in early risk assessment and management strategies."

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

Impact of Intravitreal Faricimab on Renal Function in Diabetic Patients (clinicaltrials.gov) - P=N/A | N=60 | Recruiting | Sponsor: University Hospital, Alexandroupolis | Active, not recruiting ➔ Recruiting

Enrollment open • Age-related Macular Degeneration • Diabetes • Diabetic Macular Edema • Macular Degeneration • Metabolic Disorders • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Impact of Intravitreal Faricimab on Renal Function in Diabetic Patients (clinicaltrials.gov) - P=N/A | N=60 | Active, not recruiting | Sponsor: University Hospital, Alexandroupolis

New trial • Age-related Macular Degeneration • Diabetes • Diabetic Macular Edema • Macular Degeneration • Metabolic Disorders • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

COAST: OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD) (clinicaltrials.gov) - P3 | N=998 | Terminated | Sponsor: Opthea Limited | Trial completion date: Jul 2026 ➔ Mar 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jul 2025 ➔ Mar 2025; The primary endpoint was not achieved in the study.

Trial completion date • Trial primary completion date • Trial termination • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Case Report of Intravitreal Aflibercept for Iris Metastasis from Small Cell Lung Carcinoma with Neovascular Glaucoma. (PubMed, Case Rep Ophthalmol) - "Despite treatment with topical eye drops, oral acetazolamide, and intravenous hypertonic mannitol, the IOP remained poorly controlled...While the prognosis of patients with metastatic iris tumors remains poor, intravitreal aflibercept injections show potential in reducing iris tumor size and lowering IOP. Although not curative, this therapeutic approach may play a significant role in the symptom management of these patients."

Journal • Glaucoma • Lung Cancer • Oncology • Ophthalmology • Pain • Small Cell Lung Cancer • Solid Tumor • Uveal Melanoma

A Study to Learn More About the Use of Aflibercept in Routine Medical Practice in Japanese Participants With Neovascular Age-related Macular Degeneration and Diabetic Macular Edema (clinicaltrials.gov) - P=N/A | N=3000 | Not yet recruiting | Sponsor: Bayer

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

Unraveling the effects of serial intravitreal Aflibercept injections on the ocular surface of patients with glaucoma and retinal comorbidity. (PubMed, Sci Rep) - "Serial IVIs of aflibercept positively affected some features of the GT-OSD, reducing conjunctival hyperemia and improving the tear film stability. These preliminary results could open to new strategies for ocular surface management in glaucoma, whether confirmed in larger prospective studies."

Journal • Glaucoma • Ophthalmology • Retinal Disorders

Efficacy and safety of dexamethasone versus intravitreal aflibercept implants for macular edema: a systematic review and meta-analysis. (PubMed, Eur J Med Res) - "Intravitreal aflibercept injections and dexamethasone implants are effective modalities for the management of ME, with each presenting distinct advantages. Dexamethasone implants minimize the frequency of treatment, while achieving superior outcomes in terms of BCVA and CRT. However, they are also associated with a heightened risk of IOP elevation and cataract formation. Conversely, aflibercept requires more frequent administration, which may result in logistical and financial challenges for patients and health care providers. Therefore, personalized treatment strategies should consider disease severity, comorbidities, and individual preferences. Future research should prioritize patient-centered outcomes, emphasizing quality of life and treatment costs while also investigating condition-specific responses to these therapeutic interventions."

Journal • Retrospective data • Cataract • Diabetic Macular Edema • Diabetic Retinopathy • Macular Edema • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion

Comparison of Endophthalmitis Rates Between Prefilled Syringes and Standard Vials in Aflibercept Intravitreal Injections: A Retrospective Study in Japan. (PubMed, J Clin Med) - "Detecting a significant difference requires a larger sample. Further studies are needed to confirm the potential benefits of prefilled syringes in reducing endophthalmitis risk."

Journal • Retrospective data • Age-related Macular Degeneration • Diabetes • Diabetic Macular Edema • Macular Degeneration • Metabolic Disorders • Ocular Infections • Ocular Inflammation • Ophthalmology • Pain • Retinal Disorders • Retinal Vein Occlusion

Two-Year Switzerland Cohort Results from a Global Observational Study Investigating Proactive Dosing with Intravitreal Aflibercept 2 mg in Neovascular Age-Related Macular Degeneration. (PubMed, J Clin Med) - "No safety concerns were identified. In Swiss routine clinical practice, functional and anatomic improvements were achieved with IVT-AFL 2 mg proactive treatment in patients with nAMD over 24 months despite a relatively high baseline BCVA."

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

Intravitreal Dexamethasone Implant for Patients With Central Retinal Vein Occlusion: Four-Year Outcomes in a Real-World Study. (PubMed, Cureus) - "In this series of patients with macular edema secondary to CRVO, a demonstrable improvement in BCVA was recorded along with CST decrease at a long-term follow-up of four years. Only naïve treatment with DEX implant negatively correlated with visual acuity outcomes, but it was not confirmed at the multivariate analysis. Therefore, there was no evidence to support a predictive relationship between demographic and baseline anatomical factors and final BCVA and CST."

Journal • Real-world evidence • Macular Edema • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion

A post-hoc analysis of intravitreal aflibercept-treated nAMD patients from ARIES & ALTAIR: predicting treatment intervals and frequency for aflibercept treat-and-extend therapy regimen using machine learning. (PubMed, Graefes Arch Clin Exp Ophthalmol) - "AI trained using transfer learning can be used to predict potential treatment needs for anti-VEGF treatment in nAMD based on SD-OCT scans at Wk 8 and Wk 16, supporting medical decisions on interval adjustments and optimizing individualized IVT-AFL treatment regimens."

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

Race and Vision Outcomes in Ranibizumab-Treated Participants With Diabetic Macular Edema: A Meta-Analysis. (PubMed, JAMA Ophthalmol) - "Five randomized clinical trials were preselected for analysis, including the RIDE and RISE trials (Ranibizumab Injection in Subjects With Clinically Significant Macular Edema With Center Involvement Secondary to Diabetes Mellitus); Protocol I (Intravitreal Ranibizumab or Triamcinolone Acetonide in Combination With Laser Photocoagulation for Diabetic Macular Edema), Protocol S (Prompt Panretinal Photocoagulation Versus Intravitreal Ranibizumab With Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy), and Protocol T (A Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab and Ranibizumab for Diabetic Macular Edema)...No difference in BCVA was observed in Black vs White participants at 2 years. Smaller enrollment numbers precluded analysis of participants of other races, suggesting lack of robust diversity beyond Black and White participants in these trials."

Clinical • Journal • Retrospective data • Diabetes • Diabetic Macular Edema • Diabetic Retinopathy • Metabolic Disorders • Ophthalmology • Retinal Disorders

Real-world Intravitreal Aflibercept 2 mg Treatment of Macular Oedema Secondary to Retinal Vein Occlusion in Italy: 24-month Results from the AURIGA Observational Study. (PubMed, Ophthalmologica) - P=N/A | "Robust VA improvements were observed in treatment-naïve patients with RVO in Italy following IVT-AFL treatment for up to 24 months in routine practice, despite a low injection frequency. However, guidelines indicate that regular, proactive treatment beyond the acute stage is required to improve long-term outcomes."

Journal • Observational data • Real-world evidence • Macular Edema • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion

Efficacy of Aflibercept (8 mg) for Diabetic Macular Edema in Vitrectomized Eyes Refractory to the Other Anti-VEGF Drug Therapies: A Report of Three Cases (Dovepress) - "The efficacy of anti-VEGF therapy for DME in vitrectomized eyes is thought to be lower than that of DME in non-vitrectomized eyes. In this case, brolucizumab, which has a high anti-VEGF molar concentration, and faricimab, which has a low anti-VEGF molar concentration but anti-angiopoietin (Ang)-2 activity, were not effective, but aflibercept (8 mg), whose VEGF molar concentration was intermediate between the two, was effective. This may be due to the fact that aflibercept (8 mg) is a fusion protein rather than an antibody, has lower clearance than a small molecule like brolucizumab, and has a higher anti-VEGF molar concentration than faricimab. It is suggested that aflibercept (8 mg) may be effective for DME in vitrectomized eyes and may merit preferential administration in such cases."

Retrospective data • Diabetic Macular Edema

Early real-world outcomes of intravitreal aflibercept 8 mg in treatment-Naïve neovascular AMD: AI-assisted fluid volume analysis. (PubMed, Int J Retina Vitreous) - "Intravitreal aflibercept 8 mg demonstrated early anatomical and functional improvements in nAMD treatment-naïve patients after the first 3-months. The use of the AI-based analysis allowed for detailed and automated assessment of retinal changes, providing valuable insights into early treatment effects. Given the retrospective design and small cohort, further studies are warranted to assess long-term outcomes and the potential predictive value of early changes on long-term visual prognosis and safety."

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

Bayer seeks EMA approval for Aflibercept for retinal vein occlusion treatment (Medical Dialogues) - "Bayer has submitted an application to the European Medicines Agency (EMA) seeking approval of aflibercept 8 mg (114.3 mg/ml solution for injection) for the treatment of patients with macular edema following retinal vein occlusion (RVO) including central, branch and hemiretinal vein occlusion. This would be the third indication for aflibercept 8 mg supporting the blockbuster status of Eylea. The submission is based on positive results from the global randomized, double-masked, active-controlled phase III QUASAR study."

EMA filing • Retinal Vein Occlusion

Efficacy and safety of intravitreal injection of aflibercept biosimilar for treating diabetic macular edema. (PubMed, Front Med (Lausanne)) - "The first positive peak amplitude improved significantly from 55.30 ± 9.45 to 72.90 ± 7.44 nv/deg2 at 6 months post-treatment (p < 0.05). Intravitreal injections of aflibercept biosimilar can significantly reduce DME, improve BCVA, enhance macular perfusion, and restore macular function."

Journal • Diabetic Macular Edema • Ophthalmology

VGFTe-OD-2457: A Real-World Evidence Study for the Incidence of Retinal Vasculitis (RV) Among Adult Patients Receiving Aflibercept 2 mg in the United States (US) (clinicaltrials.gov) - P=N/A | N=550000 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals | Initiation date: Jan 2025 ➔ Apr 2025 | Trial primary completion date: Feb 2025 ➔ May 2025

HEOR • Real-world evidence • Trial initiation date • Trial primary completion date • Ocular Inflammation • Vasculitis

A Phase 3 Clinical Trial to Compare RBS-001 to Eylea® in Subjects With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P3 | N=434 | Not yet recruiting | Sponsor: Rophibio, Inc. | Initiation date: Jan 2025 ➔ Jul 2025

Trial initiation date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Occlusive Retinal Vasculitis After Aflibercept 8mg Injection for Wet Macular Degeneration. (PubMed, Retin Cases Brief Rep) - "ORV is a rare complication of some intravitreal anti-VEGF medications and infectious causes of endophthalmitis. It can be managed with aggressive steroid treatment for an excellent visual outcome in some cases, although the disease may be chronic or recurrent."

Journal • Age-related Macular Degeneration • Inflammation • Macular Degeneration • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders • Uveitis • Vasculitis • Wet Age-related Macular Degeneration

Intravitreal aflibercept for macular edema due to central retinal vein occlusion: 5-year results of a real-world study (INTRAMED-CRVO). (PubMed, Retina) - "At the 5-year follow-up, intravitreal aflibercept showed a mean gain of 11.5 letters in BCVA with an average of 23.7 injections. 31.4% of patients achieved a treatment interval of ≥12 weeks, while about half of patients showed good treatment response."

Journal • Real-world evidence • Macular Edema • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion

Efficacy of the Treat-and-Extend Regimen in the Management of Neovascular Age-related Macular Degeneration: 10-year Results of the RENO Study (ARVO 2025) - "The T&E regimen has been effective in maintaining visual acuity in nAMD patients treated with ranibizumab, aflibercept, bevacizumab, brolucizumab, or faricimab for up to ten years of treatment. 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 • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Demographics and intraocular pressure (IOP) spike rates of neovascular age-related macular degeneration patients: IOP outcomes after 72,855 intravitreal injections from 2014 - 2024 from a single hospital in the United Kingdom (ARVO 2025) - "Included for analysis were Eylea 2mg (Aflibercept), Vabysmo (Faricimab), Ongavia (Ranibizumab biosimilar), Beovu (Brolucizumab), Lucentis (Ranibizumab), and Avastin (Bevacizumab). Our study found that Eylea 2mg, a commonly used anti-VEGF agent, may be associated with increased IOP spike rate compared to other agents. Understanding differences in post-injection IOP profile among various intravitreal agents across broad patient demographics can help ophthalmologists provide well-tailored treatments for wet AMD patients."

Clinical • Age-related Macular Degeneration • Glaucoma • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration