PULSAR PHASE3 COMPLETED n=1009
Drug: EYLEA HD · REGN
Study Design
DesignRandomized, double-masked, active-controlled, multicenter
Randomization1:1:1
BlindingDouble-masked
Enrollment1009
Duration48 weeks
Treatment Arms
EYLEA HD 8mg Q12W 8mg intravitreal Q12W (after 3 monthly loading) n=335
EYLEA HD 8mg Q16W 8mg intravitreal Q16W (after 3 monthly loading, Q12W x2) n=338
EYLEA 2mg Q8W (active control) 2mg intravitreal Q8W (after 3 monthly loading) n=336
Primary Endpoints
[{"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 HD Q12W"},{"notes":"Non-inferior to EYLEA 2mg Q8W","value":7.6,"arm_id":"eyleahd-q16-pulsar","arm_name":"EYLEA HD Q16W"},{"value":8.7,"arm_id":"eylea-q8w-pulsar","arm_name":"EYLEA 2mg Q8W"}],"timepoint":"Week 48","description":"Mean change from baseline in best-corrected visual acuity (ETDRS letters) at Week 48. Non-inferiority of EYLEA HD extended dosing vs EYLEA 2mg Q8W."}]
Efficacy Results
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 Results
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.
Assessment
PULSAR is the biosimilar defense strategy. EYLEA HD enables Q16W dosing (79% of patients = 4 injections/year). Biosimilar EYLEA 2mg requires Q8W (7 injections/year). Retina docs will prefer the branded product that cuts injection burden in half. This buys REGN several years of franchise protection.
Background & Context
Higher aflibercept dose (8mg vs 2mg) enables extended dosing intervals. Key for patient compliance and clinic burden.
Data from Supabase · Updated 2026-03-24