Izervay intravitreal solution (avacincaptad pegol, Astellas) has been approved by the Therapeutic Goods Administration (TGA) for the treatment of adult patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) with an intact fovea and when central vision is threatened by GA lesion growth.

Regulatory approval was based on the global GATHER1 and GATHER2 clinical trials, which successfully met primary endpoints by significantly reducing the rate of GA lesion growth compared with sham treatment.1,2

Over 12 months, Izervay demonstrated a mean reduction in GA lesion growth of 35% in the GATHER1 trial and 18% in GATHER2.3 Sustained efficacy was evident over two years of follow-up, with clinical benefit observed as early as six months following the first injection.1,2,4

Izervay was consistently well-tolerated, with fewer than 2% of participants discontinuing treatment due to adverse events.1,2

Professor Robyn Guymer, Deputy Director, Centre for Eye Research Australia and Professor of Surgery (Ophthalmology), University of Melbourne described the registration as “a pivotal milestone for the Australian ophthalmology community and, most importantly, for patients living with geographic atrophy”.

“For too long, GA has remained an area of significant unmet need, with patients facing progressive and irreversible vision loss without a viable treatment option. Izervay’s approval brings new hope and a tangible step forward in our ability to intervene in this common, devastating cause of vision loss.”

She said availability of Izervay in Australia “opens the door to further advancements in retinal disease management”.

References available at mivision.com.au.