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

Eylea - opinion on variation to marketing authorisation (European Medicines Agency) - "On 11 December 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Eylea. The marketing authorisation holder for this medicinal product is Bayer AG...The CHMP adopted a new indication for Eylea 114.3 mg/ml solution for injection, as follows: Eylea is indicated in adults for the treatment of neovascular (wet) age related macular degeneration (nAMD); visual impairment due to diabetic macular edema (DME); visual impairment due to macular edema secondary to retinal vein occlusion (branch, central and hemiretinal RVO)."

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

Clinical Characteristics of Patients with Neovascular Age-Related Macular Degeneration and Responses to Anti-VEGF Therapy: Four-Group Stratification Based on Drusen and Punctate Hyperfluorescence. (PubMed, J Clin Med) - " nAMD stratified based on drusen and PH differed in age, choroidal thickness, and IVA outcomes. The four-category framework provides greater pathophysiologic and therapeutic resolution than the simple PNV/non-PNV dichotomy and may help anticipate injection demand to guide individualized dosing strategies."

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

Competing Beyond the First Mover: How Late to Market Analogues Navigate Pricing and Access in Major Global Markets (ISPOR-EU 2025) - "HTA, pricing outcomes and payer perceptions for ten analogues (such as Alecensa, Zejula, Rozlytrek, Eylea, Fasenra) were analysed across seven global markets (US, Germany, France, Spain, UK, Brazil, Canada). Several distinct pricing strategies (discounting, parity or premium) were observed which were highly dependent on the level of clinical differentiation vs. earlier to market options. Analogue assessment considered clinical and other non clinical factors that impacted their pricing and access success or failure which can potentially be used as a guide for future portfolio development and optimisation. Demonstrating clinical differentiation vs. earlier entrants is the critical factor translating into positive HTA outcomes and securing a price premium."

Clinical • Pricing

Efficacy of aflibercept in vitrectomized vs. non-vitrectomized eyes with diabetic macular edema: a prospective study. (PubMed, Int J Retina Vitreous) - "IVA is effective for DME regardless of vitreous status, with similar efficacy and treatment frequency in vitrectomized and non-vitrectomized eyes. DEX implantation produces anatomical benefits in IVA-refractory cases, although visual gains are limited."

Journal • Diabetes • Diabetic Macular Edema • Metabolic Disorders • Ophthalmology

SPARROW: Comparison of Rapid Aflibercept and Brolucizumab T&E in wAMD (clinicaltrials.gov) - P=N/A | N=80 | Active, not recruiting | Sponsor: Berner Augenklinik | Enrolling by invitation ➔ Active, not recruiting

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

Real-Life Clinical Outcomes of Aflibercept Biosimilar MY-1701P in the Treatment of Exudative Age-Related Macular Degeneration (clinicaltrials.gov) - P=N/A | N=54 | Recruiting | Sponsor: Saglik Bilimleri Universitesi | Not yet recruiting ➔ Recruiting

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

Intraocular inflammation following aflibercept 8 mg: real-world data from a multicentre retrospective observational study. (PubMed, Int J Retina Vitreous) - No abstract available

Journal • Observational data • Real-world evidence • Retrospective data • Inflammation • Ocular Inflammation

Expanding insights from the VISTA phase III trial: longitudinal comparative assessment of ellipsoid zone integrity and volumetric fluid dynamics. (PubMed, Sci Rep) - P3 | "No significant differences in treatment response were observed across racial/ethnic groups. These findings highlight the importance of consistent fluid control and demonstrate the utility of machine learning-derived EZ metrics and fluid stability as imaging biomarkers to guide personalized treatment strategies and optimize long-term visual outcomes.Registry: ClinicalTrials.gov, TRN: NCT01363440, Registration date: 27 May 2011."

Clinical • Journal • P3 data • Diabetic Macular Edema • Ophthalmology

Investigating Predictors of Retreatment following Initial Antivascular Endothelial Growth Factor Therapy for Retinopathy of Prematurity: A Systematic Review and Meta-Analysis. (PubMed, J Curr Ophthalmol) - "Among children treated with anti-VEGF agents, the highest IR occurred with intravitreal ranibizumab (IVR, 0.25 mg) (27%, 95% CI: 19%-35%) and intravitreal aflibercept (IVA, 0.4 mg) (27%, 95% CI: 6%-47%), followed by intravitreal conbercept (IVC, 0.25 mg) (16%, 95% CI: 13%-20%). The lowest IR was observed in children treated with intravitreal bevacizumab (IVB, 0.625 mg) (11%, 95% CI: 7%-14%)...While anti-VEGF therapy is effective for ROP treatment, there are significant differences in IR among different agents. IVB treatment appears to yield the most consistent results compared to other agents."

Journal • Retrospective data • Review • Retinal Disorders • Retinopathy of Prematurity

The Efficacy of Intravitreal Aflibercept Injection in Improvement of Retinal Nonperfusion in Diabetic Retinopathy (clinicaltrials.gov) - P2 | N=38 | Completed | Sponsor: Asan Medical Center | Unknown status ➔ Completed

Trial completion • Diabetic Retinopathy • Retinal Disorders

Significant Correlation Between Choroidal Thickness and Decrease in Choroidal Blood Flow After Switching to Brolucizumab for Refractory Neovascular Age-Related Macular Degeneration. (PubMed, Ophthalmol Ther) - "IVBr is associated with significant reductions in CRT and SFCT and may decrease choroidal blood flow, particularly in older patients and those with thinner SFCTs."

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

High-Dose 8 mg Aflibercept for Neovascular Age-Related Macular Degeneration: Who Is Being Treated with This New Agent? (PubMed, Life (Basel)) - "The last treatment before switching was 2 mg aflibercept in 76%, faricimab in 18%, ranibizumab in 3% and bevacizumab in 3% of cases...The main reasons for switching were recalcitrant nAMD with persistent fluid despite q4w dosing (50%) or the wish for treatment extension beyond 6 weeks (32%). In the future, these data will aid in the design of prospective real-world studies comparing the efficacy of high-dose 8 mg aflibercept with older generation treatment options, especially 2 mg aflibercept."

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

Efficacy of faricimab for recalcitrant multifactorial cystoid macular edema. (PubMed, Am J Ophthalmol Case Rep) - "This manuscript describes a case of recalcitrant postoperative cystoid macular edema (CME), confounded by a history of branch retinal vein occlusion (BRVO), in which faricimab resulted in resolution of CME after incomplete response to topical anti-inflammation drops, intravitreal aflibercept and bevacizumab, a corticosteroid intravitreal implant, grid laser therapy, and suprachoroidal triamcinolone acetonide (SCS-TA)...CME persisted for eight years despite treatment with topical anti-inflammatories, anti-VEGF injections, a dexamethasone intravitreal implant, grid laser therapy, and a SCS-TA injection...This case demonstrates the effectiveness of faricimab in treatment of CME resistant to other therapies and the importance of continued attempts at using new agents for chronic, recurrent CME. The unique benefits of new agents like faricimab, with both VEGF and Ang-2 inhibition, may be particularly helpful in mixed or inflammatory CME when other proven therapies have failed."

Journal • Age-related Macular Degeneration • Cardiovascular • Diabetic Macular Edema • Glaucoma • Inflammation • Macular Degeneration • Macular Edema • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Increased aqueous flare after intravitreal brolucizumab injections compared to aflibercept in neovascular age-related macular degeneration. (PubMed, Graefes Arch Clin Exp Ophthalmol) - "In nAMD, aqueous flare values were higher in brolucizumab-treated eyes and increased with age but were unaffected by the number of injections. Different flare values of each drug might affect the aqueous flare values within hours after injection."

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

Retinal phlebitis complicated by punctate inner choroidopathy-like lesions: a case report. (PubMed, Am J Ophthalmol Case Rep) - "Treatment with oral prednisolone and sub-Tenon triamcinolone acetonide injections controlled the inflammation, and intravitreal aflibercept injections managed the CNV. At the two-year follow-up, the corrected visual acuity improved to 1.2. The distribution of lesions along the retinal veins suggests that this case represents a presentation of PIC-like lesions secondary to retinal phlebitis."

Journal • Inflammation • Ophthalmology • Retinal Disorders

Impact of intravitreal aflibercept on ocular and periocular tissue elasticity: a shear wave elastography study in diabetic retinopathy. (PubMed, BMC Med Imaging) - No abstract available

Journal • Diabetes • Diabetic Retinopathy • Metabolic Disorders • Retinal Disorders

Intravitreal Aflibercept for the Treatment of Diabetic Retinopathy Among Patients Who Completed PANORAMA: 1-Year Outcomes from the VOYAGE Extension Study. (PubMed, J Pers Med) - P4 | "There were no unexpected safety events. Following a mean of 3 years of routine clinical care with associated declines in DRSS level, CST, and BCVA, stabilization of DRSS level and BCVA with reductions in CST was achieved through year 1 of the VOYAGE extension study, with a concurrent increase in aflibercept dosing frequency."

Journal • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

Real-Life Clinical Outcomes of Aflibercept Biosimilar MY-1701P in the Treatment of Exudative Age-Related Macular Degeneration (clinicaltrials.gov) - P=N/A | N=54 | Not yet recruiting | Sponsor: Saglik Bilimleri Universitesi

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

siRASA1 in vascular endothelial cells alleviates subretinal fibrosis through inhibiting macrophage-myofibroblast transdifferentiation via SHH signaling pathway. (PubMed, Cell Signal) - "To therapeutically disrupt this circuit, we engineered a multifunctional nanoparticle system, MGPDA@Eylea/siRASA1, for the co-delivery of siRASA1 and the anti-VEGF drug Eylea. This nanotherapeutic demonstrated excellent biocompatibility and effectively attenuated the fibrotic cascade by suppressing RASA1 expression, inhibiting SHH signaling, and mitigating macrophage-to-myofibroblast transition (MMT), thereby delaying SRF progression. Our work unveils a previously unrecognized intercellular circuit driving fibrosis and presents a promising nanomedicine-based strategy for managing fibrotic complications in nAMD."

Journal • Age-related Macular Degeneration • Fibrosis • Immunology • Inflammation • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • EFNB2 • EPHB4 • GLI1 • PTCH1 • RASA1

SAHLVE: The Sahlgrenska Anti-VEGF Study (clinicaltrials.gov) - P2 | N=402 | Active, not recruiting | Sponsor: Vastra Gotaland Region | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2024 ➔ May 2027 | Trial primary completion date: Sep 2024 ➔ Oct 2026

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

Aflibercept 2 mg for Neovascular Age-Related Macular Degeneration: XTEND at 3 Years. (PubMed, Ophthalmologica) - P | "This study demonstrates that improvements with IVT-AFL 2 mg were maintained through Month 36, suggesting that long-term durability of vision is achievable in patients with treatment-naïve nAMD in real-world practice."

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

Intravitreal faricimab in patients with aflibercept-refractory neovascular age-related macular degeneration: short and long-term outcomes and assessment of volume dynamics using an artificial intelligence-based tool. (PubMed, Int J Retina Vitreous) - "Faricimab may offer a valuable alternative for patients with refractory nAMD. The use of four loading injections administered monthly, followed by a treat-and-extend regimen can result in maintenance of visual acuity and improve anatomical parameters and retinal fluid activity, allowing for longer treatment intervals."

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

ARTEMIS: Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P3 | N=284 | Recruiting | Sponsor: Adverum Biotechnologies, Inc. | Trial completion date: Mar 2030 ➔ Nov 2030 | Trial primary completion date: Apr 2027 ➔ Dec 2026

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

The SPECTRUM Study: An Observational Study to Learn More About How Well Aflibercept 8 mg Works in Treating Visual Impairment Due to Neovascular Age-related Macular Degeneration or Diabetic Macula Edema (clinicaltrials.gov) - P=N/A | N=2500 | Active, not recruiting | Sponsor: Bayer | Recruiting ➔ Active, not recruiting

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

PRO-CON: IAI Versus Sham as Prophylaxis Against Conversion to Neovascular AMD (clinicaltrials.gov) - P2 | N=128 | Completed | Sponsor: Jeffrey S Heier | Unknown status ➔ Completed

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