There was mixed news for Allergan this week after US regulators turned away its migraine aerosol treatment Semprana (dihydroergotamine) again but issued a new green light for eye implant Ozurdex (dexamethasone).
The drugmaker, currently the object of a hostile takeover attempt by Valeant Pharmaceuticals, said the US Food and Drug Administration has issued a second complete response letter (CRL) for Semprana (previously referred to as Levadex), adding a delay to its potential approval.
However, the two specific items listed in the CRL are not related to the clinical safety and efficacy of the product, being centred on the product’s delivery device instead, and Allergan estimates that the next FDA action will occur by the end of the second quarter next year.
Ozurdex expanded
On the plus side, the regulator did approve Ozurdex as a new option for diabetic macular oedema (DME) in adult patients who have an artificial lens implant (pseudophakic) or who are scheduled for cataract surgery (phakic).
Ozurdex is a sustained-release biodegradable steroid implant that contains the potent corticosteroid dexamethasone, which is slowly released to control oedema, tackle inflammation and improve vision, already on the market for treating macular oedema and certain ocular inflammations.
Allergan also said it is advancing two of key programmes into Phase III development – Anti-VEGF DARPin in neovascular, or “wet,” age-related macular degeneration (AMD), and bimatoprost sustained-release implant for the treatment of elevated intraocular pressure and glaucoma.
