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Sep 9, 2022

Aflibercept 8 mg Meets Primary Endpoints in Two Global Pivotal Trials for DME and wAMD, with a Vast Majority of Patients Maintained on 12- and 16-week Dosing Intervals

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Regeneron Pharmaceuticals, Inc.  Sep 08, 2022, 09:00 ET

91% and 89% of diabetic macular edema (DME) patients were rapidly initiated and maintained on 12- and 16-week dosing intervals (without need for regimen modification) through week 48, respectively

79% and 77% of wet age-related macular degeneration (wAMD) patients were rapidly initiated and maintained on 12- and 16-week dosing intervals (without need for regimen modification) through week 48, respectively

Safety of aflibercept 8 mg consistent with the established safety profile of EYLEA® (aflibercept) Injection

TARRYTOWN, N.Y.Sept. 8, 2022 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the primary endpoints were met in two pivotal trials investigating novel aflibercept 8 mg with 12- and 16-week dosing regimens in patients with diabetic macular edema (DME) and wet age-related macular degeneration (wAMD). The PHOTON trial in DME and the PULSAR trial in wAMD both demonstrated that aflibercept 8 mg 12- and 16-week dosing regimens achieved non-inferiority in vision gains compared to the EYLEA 8-week dosing regimen. In these trials, the safety of aflibercept 8 mg was consistent with the established safety profile of EYLEA. Regeneron and Bayer will submit these data to regulatory authorities in countries around the world.

“These pivotal aflibercept 8 mg trials demonstrated that nearly 90% of patients with diabetic macular edema and almost 80% of patients with wet age-related macular degeneration were able to maintain a 16-week dosing regimen,” said David Brown, M.D., FACS, Director of Research at Retina Consultants of Texas in the U.S. and a trial investigator. “These unprecedented durability data coupled with a safety profile consistent with that of EYLEA support aflibercept 8 mg as a potential new standard-of-care in these diseases.”

“These groundbreaking results are excellent news for patients. These outcomes have shown that aflibercept 8 mg not only improved vision with less frequent injections, but also demonstrated a similar safety profile to EYLEA,” said Jean-François Korobelnik, M.D., Ph.D., Professor of Ophthalmology and Head of the Department of Ophthalmology at University Hospital of Bordeaux in France and a trial investigator….

Read more: https://www.prnewswire.com/news-releases/aflibercept-8-mg-meets-primary-endpoints-in-two-global-pivotal-trials-for-dme-and-wamd-with-a-vast-majority-of-patients-maintained-on-12–and-16-week-dosing-intervals-301620404.html

Source: CISION PR Newswire

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