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News & Trends - Pharmaceuticals

New report urges action on geographic atrophy as Apellis and Astellas navigate regulatory hurdles

Health Industry Hub | September 16, 2024 |

Pharma News: In an event held at Parliament House in Canberra, Macular Disease Foundation Australia (MDFA) CEO Dr Kathy Chapman unveiled a new report titled Geographic Atrophy: We Can’t Wait and See – The Case for Action.

Geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD), affects between 75,000 and 100,000 Australians. The report revealed the economic argument for addressing GA: every $1 invested in preventing vision loss and legal blindness from GA generates $2.21 in social value.

The launch of the report was supported by Ministers Meryl Swanson MP and Dr David Gillespie MP, Co-Chairs of the Parliamentary Friends of Eye Health and Vision Care.

Dr Gillespie highlighted the urgency of the report, stating, “The report provides a case for urgent action to address geographic atrophy. We heard a very personal story from Colin and his family who are living with this debilitating disease.”

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The report was sponsored by Apellis, which is currently seeking a PBS listing for Syfovre (pegcetacoplan injection), a complement C3 inhibitor.

Globally, the company has faced challenges that has delayed Syfovre’s launch. A recent report from the American Society of Retina Specialists described patients who developed retinal vasculitis, a severe complication after treatment with Syfovre, including two patients who needed to have an eye removed. In Australia, Apellis withdrew its application from the March PBAC meeting agenda, further stalling its progress locally.

In parallel, Astellas is advancing local regulatory approval for Izervay (avacincaptad pegol), a complement C5 inhibitor, for the treatment of GA. Data from the GATHER1 and GATHER2 studies, presented at the 2024 ARVO Annual Meeting in May, demonstrated Izervay’s efficacy in slowing GA progression, with treatment effects nearly doubling every six months.

Supported by a diverse advisory committee, including Vision 2020 Australia, Vision Australia, Retina Australia, Optometry Australia, and Sight For All, the MDFA report underscores the collaborative efforts in tackling inaction in GA.

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