Izervay, a complement C5 inhibitor, was recently approved to treat geographic atrophy. Photo: Iveric Bio. Click image to enlarge.
On Friday, the FDA gave the stamp of approval to a second drug joining the emerging market for geographic atrophy (GA) treatment: Izervay (avacincaptad pegol intravitreal solution, 2mg). The complement C5 inhibitor, developed by Iveric Bio, demonstrated an ability to significantly reduce the rate of disease progression at 12 months in both Phase III clinical trials, Gather1 and Gather2.
The drug is intended to be administered monthly via intravitreal injection to patients with GA secondary to age-related macular degeneration. In Phase III trials, slowing of disease progression was observed after as few as six injections; after 12 injections, patients experienced up to a 35% reduction in GA progression rate compared with sham.
Iveric Bio noted in its press release that the most common adverse reactions reported by patients at 12 months were conjunctival hemorrhage (13%), increased intraocular pressure (9%) and blurry vision (8%).
The company notes that Izervay should be available to eyecare professionals and their patients in two to four weeks.
For more information, go to www.ivericbio.com.