EYLEA aflibercept 2mg APPROVED
Drug Profile
ModalityFusion protein
RouteIntravitreal
Therapy AreaOphthalmology
Launch2011-11-18
Peak Sales Est$9000M
Formulations[{"id":"eylea-ivt-2mg","doses":"2mg (0.05 mL) intravitreal injection","route":"Intravitreal injectio
Companies
REGN (ORIGINATOR)100%
BAYN (LICENSEE)0%
Mechanism: VEGF trap (fusion protein)
Expert: Recombinant fusion protein combining VEGF-binding domains from VEGFR1 and VEGFR2 fused to IgG1 Fc. Binds VEGF-A (all isoforms), VEGF-B, and placental growth factor (PlGF). Intravitreal injection. Higher VEGF-binding affinity than ranibizumab.
Everyday: A decoy receptor that soaks up VEGF — the protein that makes abnormal blood vessels grow in the eye. By trapping VEGF before it can signal, it stops the leaky blood vessels that cause vision loss. Like a sponge that absorbs the signal before it reaches its target.
Targets: ["VEGF-A","VEGF-B","PlGF"]
Revenue History
PeriodRevenue ($M)
Q1 2024$1,202M
Q2 2024$1,231M
Q3 2024$1,145M
Q4 2024$1,190M
2024$4,767M
Q1 2025$736M
Q2 2025$754M
Q3 2025$681M
Q4 2025$577M
2025$2,748M
Programs (4)
IndicationStageKey StudyRegional Status
wAMDAPPROVEDVIEW 1/2[{"stage":"APPROVED","region":"US","approval_date":"2011-11-18"}]
DMEAPPROVEDVIVID/VISTA[{"stage":"APPROVED","region":"US","approval_date":"2014-07-29"}]
Macular edema from RVOAPPROVEDCOPERNICUS/GALILEO[{"stage":"APPROVED","region":"US","approval_date":"2012-09-21"}]
Diabetic retinopathyAPPROVEDPANORAMA[{"stage":"APPROVED","region":"US","approval_date":"2019-05-13"}]
Clinical Studies (2)
VIEW 1 PHASE3
COMPLETED · n=1217
Primary EP: [{"id":"view1-vision","name":"Maintained vision at Week 52 (lost <15 letters)","type":"PRIMARY","unit":"%","results":[{"notes":"Non-inferior to ranibizumab. Difference +0.6% (95.1% CI -3.2 to 4.4)","v
Efficacy: VIEW 1 met primary endpoint: EYLEA 2mg Q8W was non-inferior to ranibizumab Q4W (94% vs 94% maintained vision). Q8W dosing enabled less frequent injections with equivalent efficacy. Mean BCVA gain: +7.9 letters (EYLEA Q8W) vs +8.1 letters (ranibizumab Q4W).
Safety: VIEW 1 (n=1217): Injection-procedure-related AEs similar across arms. Conjunctival hemorrhage 25% vs 28%, eye pain 9% vs 9%, cataract 7% vs 7%, IOP increased 5% vs 7%. Endophthalmitis <0.1% per inject
NCT00509795
VIEW 2 PHASE3
COMPLETED · n=1240
Primary EP: [{"id":"view2-vision","name":"Maintained vision at Week 52 (lost <15 letters)","type":"PRIMARY","unit":"%","results":[{"notes":"Non-inferior to ranibizumab. 95.6% vs 94.4%","value":95,"arm_id":"eylea-
Efficacy: VIEW 2 confirmed VIEW 1: EYLEA Q8W (95.6%) was non-inferior to ranibizumab Q4W (94.4%) for vision maintenance. Pooled VIEW 1+2 analysis led to FDA approval in 2011.
Safety: VIEW 2 (n=1240): Similar safety profile to VIEW 1. Conjunctival hemorrhage, eye pain, and IOP increase most common. Endophthalmitis <0.1%.
NCT00637377
Upcoming Catalysts (1)
EYLEA 2mg Biosimilar Competition Impact 2026 (ongoing)
Notes
DECLINING — biosimilar threat is the key bear case. EYLEA 2mg facing multiple biosimilar approvals starting 2025. US net sales declining as patients transition to EYLEA HD (8mg). Bayer holds ex-US license. EYLEA franchise (2mg + HD combined) still ~$5.5B+ US, but trajectory is down for 2mg formulation.
Safety Profile
{"keyRisks":[{"category":"Endophthalmitis","description":"Serious intraocular infection. Risk with any intravitreal injection. Proper aseptic technique required.","incidenceRate":"0.1% per injection"},{"category":"Retinal detachment","description":"Rare but serious complication of intravitreal injection procedure.","incidenceRate":"<0.1%"},{"category":"IOP increase","description":"Transient intraocular pressure elevation within 60 minutes of injection. Monitor and manage.","incidenceRate":"5-7%"},{"category":"Conjunctival hemorrhage","description":"Most common AE — subconjunctival bleeding at injection site. Self-limiting.","incidenceRate":"25-28%"},{"category":"Eye pain","description":"Pain at injection site, typically mild and transient.","incidenceRate":"9%"},{"category":"Arterial thromboembolic events","description":"Anti-VEGF class risk. Stroke, MI reported at low rates. Similar across VEGF inhibitors.","incidenceRate":"1-2%"}],"monitoring":["IOP check post-injection","Dilated fundus exam before each injection","Instruct patient to report eye pain, vision loss, floaters immediately"],"classWarnings":["Anti-VEGF: theoretical risk of arterial thromboembolic events","Intravitreal injection procedure carries endophthalmitis/retinal detachment risk"],"hasBoxedWarning":false}
Data from Supabase · Updated 2026-03-24