7 hours ago
Astellas’ IZERVAY® (avacincaptad pegol) has been approved for use in Australia by the TGA
Astellas Pharma Australia Pty Ltd has received Therapeutic Goods Administration (TGA) registration for IZERVAY (avacincaptad pegol) intravitreal solution, approved for the treatment of adult patients with geographic atrophy (GA).
Retina Australia welcomes this news, being the second treatment for GA approved in Australia in the last 10 months, following the registration of SYFOVRE® (pegcetacoplan) by Apellis Pharmaceuticals, Inc. in January.
The approval of IZERVAY offers greater choice and hope to more than 75,000 Australians living with GA, helping to slow vision loss and preserve independence and quality of life.
GA is a severe and progressive form of age-related macular degeneration (AMD) often leading to significant visual impairment or legal blindness.
IZERVAY (avacincaptad pegol) is approved to treat those with an intact fovea and threatened central vision. Approval was based on the GATHER1 and GATHER2 global trials, where IZERVAY significantly slowed GA lesion growth, by 35% and 18% respectively over 12 months. Sustained efficacy was observed over two years, with benefits evident as early as six months. The treatment was well tolerated, with fewer than 2% of participants discontinuing due to adverse events.
https://retinaaustralia.com.au/australia-approves-second-treatment-for-geographic-atrophy/
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