Allergan wins US approval for diabetic vision-loss treatment

Migraine inhaler fails to secure go-ahead, with FDA citing delivery issues

The Food and Drug Administration approved Allergan’s Ozurdex, a drug for diabetic macular edema, which can cause vision loss and eventual blindness in people with diabetes, according to a regulatory filing today.

The Food and Drug Administration approved Allergan’s Ozurdex, a drug for diabetic macular edema, which can cause vision loss and eventual blindness in people with diabetes, according to a regulatory filing today.

 

Allergan, the drugmaker resisting a takeover by Valeant Pharmaceuticals International , won US approval for a treatment of vision loss in diabetics and rejection for its migraine inhaler.

The Food and Drug Administration approved Allergan’s Ozurdex, a drug for diabetic macular edema, which can cause vision loss and eventual blindness in people with diabetes, according to a regulatory filing today.

The agency rejected Semprana, formerly known as Levadex, an inhalable treatment for migraines, because of problems with the drug’s delivery device.

An eventual approval for Levadex could “vindicate” Allergan’s research capabilities and its argument to investors that it’s better off alone than as part of Valeant, according to Shibani Malhotra, an analyst at Sterne Agee and Leach.

Allergan plans to meet with the FDA about Semprana and estimates the agency could have an answer on the drug by July, 2015, according to the filing. Allergan, based in Irvine, California, is resisting a $54 billion takeover offer by Valeant, which has twice raised its bid as it seeks to become one of the world’s five biggest drugmakers. - Bloomberg