- Organizations: Regeneron
Products
FDA accepts Regeneron's EYLEA HD sBLA for priority review
Agency sets target action date of Aug. 19 to consider a new indication for macular edema following RVO and expanded monthly dosing.
Products
Settlement paves way for US commercialization of Eylea biosimilar
Biocon Biologic’s YESAFILI (aflibercept-jbvf) now expected to launch in H2 2026 after dismissal of Regeneron’s patent infringement lawsuits.Pipeline
Extended phase 3 study reports 3-year durability of EYLEA HD for wet AMD
Regeneron reports the majority of patients maintained visual and anatomic outcomes while achieving extended dosing regiments—including those switching from aflibercept 2 mg.Pipeline
New phase 3 data supports Eylea HD for macular edema following RVO
Trial finds aflibercept 8 mg led to improved vision with extended dose intervals when compared to EYLEA 2 mg as Regeneron plans for a Q1 2025 sBLA submission.
Business
Regeneron reportedly purchases British biotech Oxular
Announcement made by CEO seemingly confirms acquisition of the retinal disease company and its lead candidate: OXU-001, a sustained-release dexamethasone formulation for DME.
Products
FDA approves first interchangeable aflibercept biosimilars
Generic equivalents to Eylea demonstrate a comparable quality, safety, and efficacy profile for wet AMD, DME, RVO, and DR.
Research
New data on Eylea HD supports prolonged dosing for wet AMD
Presented at ARVO, 96-week extending dosing supports reduced need for frequent injections.
Legal
Regeneron faces DOJ complaint in alleged Medicare overcharge of Eylea
The U.S. government alleges the company knowingly submitted false average sales prices and, as a result, inflated reimbursements rates.Research
Regeneron reports extended dosing data on EYLEA HD for wet AMD and DME
Published in The Lancet, extended dosing intervals at 12 and 16 weeks shows potential for fewer injections
Legal
Regeneron files lawsuit against potential Eylea biosimilar
Company alleges Celltrion’s CT-P42 biosimilar poses a direct threat to its patented technology.Products
FDA approves Eylea HD for vision-threatening retinal diseases
High-dose drug is already approved as a lower dosage for wet AMD, DME, DR, and ROP.
Pipeline
Regeneron releases 2-year PULSAR trial data on aflibercept 8 mg for wet AMD
Findings show a similar efficacy profile to 2-year data from PHOTON trial for DME.
Pipeline
Regeneron releases 2-year data on aflibercept 8 mg for DME
New findings support 1-year data of interval dosing maintenance; shows similarities to Eylea clinical data.
Pipeline
FDA declines BLA approval for Regeneron's high-dose aflibercept
Agency bases response on an ongoing review of inspection findings at a third-party filler.
Pipeline
OpRegen phase 1/2a trial data shows promise for GA
OpRegen RPE cell therapy is being developed and marketed through a global collaboration with Lineage Cell Therapeutics, Roche, and Regeneron.
Pipeline
FDA grants aflibercept priority review for retinal diseases
Regeneron and Bayer AG are jointly developing aflibercept 8 mg to treat wet AMD, DME, and diabetic retinopathy.
Pipeline
FDA approves Eylea for ROP in preterm infants
Latest approval is the first pharmacologic treatment for this patient group.
Legal