Allergan gains FDA approval for Durysta

The US Food and Drug Administration has approved the New Drug Application (NDA) for Durysta (bimatoprost implant) 10mcg for intracameral administration that was submitted by Allergan (NYSE: AGN).

With this approval, Durysta becomes the first intracameral, biodegradable sustained-release implant indicated to reduce intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT), according to Allergan, which is the subject of a $63 billion acquisition by AbbVie (NYSE: ABBV) that is expected to close in the second quarter of this year.

“Today's FDA approval marks a breakthrough milestone for the glaucoma community and provides a much-needed option for patients challenged with topical drops or needing alternative options," said David Nicholson, chief research and development officer, Allergan.