Press release
EYLEA® HD (aflibercept) Injection 8 mg Data Presentations at AAO Reinforce Efficacy and Safety Profile in Wet Age-related Macular Degeneration and Diabetic Macular Edema
Long-term data and subgroup analyses from pivotal EYLEA HD clinical program highlight durability of visual improvements and consistent safety across extended
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"Long-term data and subgroup analyses from pivotal EYLEA HD clinical program highlight durability of visual improvements and consistent safety across extended dosing intervals and patient characteristics\nTARRYTOWN, N.Y., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced long-term outcomes and new analyses of pivotal clinical data for EYLEA® HD (aflibercept) Injection 8 mg will be presented at the American Academy of Ophthalmology (AAO) annual meeting in San Francisco from November 3 to 6. “Following the approval of EYLEA HD, we have continued to evaluate data from the pivotal clinical program to identify new insights that may support physicians in administering this innovative treatment to patients living with certain serious retinal diseases,” said Boaz Hirshberg, M.D., Senior Vice President, Clinical Development, Internal Medicine at Regeneron. “At this year’s AAO, we will present a wide-ranging review of results from the PULSAR and PHOTON trials in wet age-related macular degeneration and diabetic macular edema. Together, they showcase the impressive durability and consistent safety profile of EYLEA HD over the long-term across different extended dosing intervals and patient characteristics.” Notable presentations include a detailed review of positive two-year (96 weeks) results from the pivotal PULSAR and PHOTON trials investigating EYLEA HD with 12- and 16-week dosing regimens, compared to EYLEA® (aflibercept) Injection 8-week dosing regimens, in patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), respectively. Additionally, subgroup data from PHOTON in DME across sex, age, race and ethnicity will be presented, as well as a pooled safety analysis from the PULSAR, PHOTON and Phase 2 CANDELA trials. Two-year data from the pivotal PULSAR trial were previously presented at the EURETINA Congress in October 2023. Two-year data from the pivotal PHOTON trial were previously presented at the American Society of Retina Specialists (ASRS) annual meeting in July 2023. EYLEA HD (known as aflibercept 8 mg outside of the U.S.) is being jointly developed by Regeneron and Bayer AG. In the U.S., Regeneron maintains exclusive rights to EYLEA and EYLEA HD. Bayer has licensed the exclusive marketing rights outside of the U.S., where the companies share equall...