Regeneron to Present New Data and Analyses of High-Dose Aflibercept at ARVO 2023

Regeneron Pharmaceuticals and its collaborator Bayer announced that aflibercept 8 mg and Eylea (aflibercept) Injection will be featured in 18 presentations at the Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting from April 23-27. Among the presentations will be new subgroup data and further analyses of aflibercept 8 mg treatment from the pivotal PULSAR and PHOTON trials in wet age-related macular degeneration (AMD) and diabetic macular edema (DME), as well as the phase 2 CANDELA trial in wet AMD.

Notable podium presentations will highlight the pivotal aflibercept 8 mg trials PULSAR and PHOTON, respectively, in wet AMD and DME with 48-week efficacy and safety results, in addition to an evaluation of baseline characteristics of patients randomized to aflibercept 8 mg who maintained their dosing intervals and those whose dosing intervals were shortened. A pooled safety analysis of aflibercept 8 mg across the PULSAR, PHOTON, and CANDELA trials will also be presented.

Data from PHOTON and PULSAR were first presented at the American Academy of Ophthalmology’s annual meeting in September 2022. In February 2023, the FDA accepted for Priority Review the Biologics License Application (BLA) for aflibercept 8 mg for treatment of patients with wet AMD, DME and diabetic retinopathy with a target action date of June 27, 2023. Aflibercept 8 mg is investigational, and its safety and efficacy have not been fully evaluated by any regulatory authority.

Aflibercept 8 mg is being jointly developed by Regeneron and Bayer AG. In the U.S., Regeneron maintains exclusive rights to Eylea and aflibercept 8 mg. Bayer has licensed the exclusive marketing rights outside of the US, where the companies share equally the profits from sales of Eylea and future sales of aflibercept 8 mg following any regulatory approvals.

Aflibercept 8 mg and Eylea presentations at ARVO:

*Bayer-run trial

About the Aflibercept 8 mg Clinical Trial Program

PULSAR in wet AMD and PHOTON in DME are double-masked, active-controlled pivotal trials that are being conducted in multiple centers globally. In both trials, patients were randomized into 3 treatment groups to receive either: aflibercept 8 mg every 12 weeks, aflibercept 8 mg every 16 weeks, or Eylea every 8 weeks. The lead sponsors of the trials were Bayer for PULSAR and Regeneron for PHOTON.

Patients treated with aflibercept 8 mg in both trials had 3 initial monthly doses, and patients treated with Eylea received 5 initial monthly doses in PHOTON and 3 in PULSAR. In the first year, patients in the aflibercept 8 mg groups could have their dosing intervals shortened down to an every 8-week interval if protocol-defined criteria for disease progression were observed. Intervals could not be extended until the second year of the study, with those results still to be assessed. Patients in all Eylea groups maintained a fixed 8-week dosing regimen throughout their participation in the trials.

CANDELA was a phase 2 trial investigating the safety and efficacy of aflibercept 8 mg extended dosing regimens compared to Eylea in wet AMD patients.