EYLEA HD aflibercept 8mg APPROVED
Drug Profile
ModalityFusion protein
RouteIntravitreal
Therapy AreaOphthalmology
Launch2023-08-18
Peak Sales Est$6000M
Formulations[{"id":"eylea-hd-ivt-8mg","doses":"8mg (0.07 mL) intravitreal injection; loading Q4W x3-5, then Q8W-
Companies
REGN (ORIGINATOR)100%
BAYN (LICENSEE)0%
Mechanism: VEGF trap (fusion protein)
Expert: Recombinant fusion protein combining VEGF-binding domains from VEGFR1 and VEGFR2 fused to IgG1 Fc. Binds VEGF-A (all isoforms), VEGF-B, and placental growth factor (PlGF). Intravitreal injection. Higher VEGF-binding affinity than ranibizumab.
Everyday: A decoy receptor that soaks up VEGF — the protein that makes abnormal blood vessels grow in the eye. By trapping VEGF before it can signal, it stops the leaky blood vessels that cause vision loss. Like a sponge that absorbs the signal before it reaches its target.
Targets: ["VEGF-A","VEGF-B","PlGF"]
Revenue History
PeriodRevenue ($M)
Q1 2024$200M
Q2 2024$304M
Q3 2024$392M
Q4 2024$305M
2024$1,201M
Q1 2025$307M
Q2 2025$393M
Q3 2025$431M
Q4 2025$506M
2025$1,637M
Programs (2)
IndicationStageKey StudyRegional Status
wAMDAPPROVEDPULSAR[{"stage":"APPROVED","region":"US","approval_date":"2023-08-18"}]
DMEAPPROVEDPHOTON[{"stage":"APPROVED","region":"US","approval_date":"2023-08-18"}]
Clinical Studies (1)
PULSAR PHASE3
COMPLETED · n=1009
Primary EP: [{"id":"pulsar-bcva","name":"Change in BCVA at Week 48","type":"PRIMARY","unit":"letters","results":[{"notes":"Non-inferior to EYLEA 2mg Q8W","value":8,"arm_id":"eyleahd-q12-pulsar","arm_name":"EYLEA
Efficacy: PULSAR met primary endpoint: EYLEA HD Q12W (+8.0 letters) and Q16W (+7.6 letters) were non-inferior to EYLEA 2mg Q8W (+8.7 letters). 79% of Q16W patients maintained the extended interval — meaning only 4 injections/year vs 6-7 with EYLEA 2mg.
Safety: PULSAR (n=1009, 48 weeks): Similar safety to EYLEA 2mg. Conjunctival hemorrhage 13%, eye pain 5%, vitreous floaters 6%. No new safety signals with 8mg dose.
NCT04423718
Notes
KEY GROWTH DRIVER — biosimilar defense. Higher dose (8mg vs 2mg) enables extended dosing intervals (up to Q16W vs Q8W). Not substitutable with 2mg biosimilars (different dose, different formulation). Ramping rapidly: +92% YoY. This is REGN's strategy to retain the retina franchise despite 2mg biosimilar competition.
Safety Profile
{"keyRisks":[{"category":"Endophthalmitis","description":"Serious intraocular infection risk with intravitreal injection.","incidenceRate":"0.1% per injection"},{"category":"IOP increase","description":"Transient IOP elevation. May be slightly higher with 8mg volume. Monitor post-injection.","incidenceRate":"7%"},{"category":"Conjunctival hemorrhage","description":"Most common AE. Self-limiting subconjunctival bleeding.","incidenceRate":"13%"},{"category":"Eye pain","description":"Pain at injection site, typically mild.","incidenceRate":"5%"},{"category":"Vitreous floaters","description":"Temporary visual disturbance from drug particles.","incidenceRate":"6%"},{"category":"Arterial thromboembolic events","description":"Anti-VEGF class risk. Low rates observed.","incidenceRate":"1-2%"}],"monitoring":["IOP check post-injection","Dilated fundus exam","Assess response to determine dosing interval (Q8W to Q16W)"],"classWarnings":["Anti-VEGF: theoretical risk of arterial thromboembolic events","Higher dose (8mg vs 2mg) enables extended dosing intervals (up to Q16W)"],"hasBoxedWarning":false}
Data from Supabase · Updated 2026-03-24