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

Shares of Regeneron fell practically 9% Tuesday after the U.S. Food and Drug Administration declined to approve a higher-dose model of the corporate’s blockbuster eye disease treatment.

The firm was searching for approval for an 8-milligram dose of its injection, Eylea, for sufferers with moist age-related macular degeneration — the main reason behind blindness among the many aged — and two different eye illnesses which might be frequent in folks with diabetes. 

Regeneron stated the rejection was “solely as a consequence of an ongoing evaluation of inspection findings at a third-party filler.”

The firm didn’t present additional particulars on these findings or determine the third occasion, however stated the choice was not associated to the drug’s efficacy, security, trial design, labeling or drug substance manufacturing. 

That suggests the drug might doubtlessly win approval down the highway. 

But a delay will not assist the corporate struggle off threats to its Eylea drug franchise, which is dealing with competitors from Roche Holdings‘ eye drug, Vabysmo. Roche’s treatment was permitted final yr.