Regeneron shares fall after FDA rejects high-dose eye disease treatment

Shares of Regeneron fell astir 9% connected Tuesday aft the U.S. Food and Drug Administration declined to approve a higher-dose mentation of the company's blockbuster oculus illness treatment.

The institution was seeking support for an 8-milligram dose of its injection, Eylea, for patients with bedewed age-related macular degeneration – the starring origin of blindness among the aged – and 2 different oculus diseases that are communal successful radical with diabetes. 

Regeneron said the rejection was "solely owed to an ongoing reappraisal of inspection findings astatine a third-party filler."

The institution did not supply further details connected those findings oregon place the 3rd party, but said the determination was not related to the drug's efficacy, safety, proceedings design, labeling oregon cause substance manufacturing. 

That suggests the cause could perchance triumph support down the road. 

But a hold won't assistance the institution combat disconnected threats to its Eylea cause franchise, which is facing contention from Roche Holdings' oculus drug, Vabysmo. Roche's attraction was approved past year.

Regeneron banal fell astir 9% Tuesday aft an FDA rejection of a higher-dose mentation of the company's blockbuster oculus treatment.