By Dean Seal

 

Regeneron Pharmaceuticals Inc. said Thursday that two pivotal trials for its diabetic macular edema and wet age-related macular degeneration treatment met their primary endpoints.

The company said 12- and 16-week dosing regimens for the eight-milligram formulation of its aflibercept treatment showed non-inferiority in vision gains compared with an eight-week dosing regimen of its Eylea injection treatment.

The safety of the eight-milligram aflibercept is consistent with the established safety profile of Eylea, Regeneron said.

The novel formulation is being jointly developed with Bayer AG. The two companies will now submit the trial data to regulators in countries around the world.

"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," said David Brown, director of research at Retina Consultants of Texas in the U.S. and a trial investigator.

Shares were halted ahead of the news and remained halted at $596.44 when the market opened Thursday.

 

Write to Dean Seal at dean.seal@wsj.com

 

(END) Dow Jones Newswires

September 08, 2022 10:04 ET (14:04 GMT)

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