aflibercept Archives - Medical Design Sourcing

[Image courtesy of Regeneron/Bayer]

Regeneron Pharmaceuticals (Nasdaq:REGN) has announced that the FDA has granted Priority Review of the supplemental Biologics License Application (sBLA) for Eylea (aflibercept) Injection to treat retinopathy of prematurity (ROP) in preterm infants.

First approved in 2011 to treat wet age-related macular degeneration, aflibercept is a blockbuster drug. Last year, it generated $9.2 billion for Regeneron and aflibercept co-developer Bayer. The drug is also indicated for diabetic retinopathy, diabetic macular edema and macular edema following retinal vein occlusion.

The Tarrytown, New York–based company has conducted two randomized Phase 3 studies testing aflibercept against laser in infants with retinopathy of prematurity. Both the FIREFLEYE and BUTTERFLEYE studies tested a 0.4 mg dose of aflibercept. Both studies found that roughly 80% of aflibercept recipients had an abs…

[Image courtesy of Regeneron/Bayer]

Increasing the dose of Regeneron‘s and Bayer‘s aflibercept (Eylea) to 8 mg led to sustained treatment intervals in patients with neovascular eye disease, according to the Phase 2/3 PHOTON and Phase 3 PULSAR clinical trials.

In both studies, dosing patients at the 8 mg dose level every 12 or 16 weeks achieved noninferiority compared to 2 mg every 8 weeks. The studies used best-corrected visual acuity (BCVA) in patients with diabetic macular edema (DME) and wet age-related macular degeneration (wAMD) to determine noninferiority.

Almost 90% of patients with diabetic macular edema and nearly 80% of patients with wet age-related macular degeneration were able to maintain a 16-week dosing regimen, noted Dr. David Brown, a trial investigator.

Brown notes that the studies’ favorable durability data and safety profile could make an 8 mg dose of afliberce…

aflibercept

FDA grants priority review of aflibercept in retinopathy of prematurity

High-dose aflibercept supports sustained vision improvement in DME and wet AMD