The Syfovre Situation

At the end of January, Apellis’s Syfovre (pegcetacoplan) was approved by Australia’s Therapeutic Goods Administration (TGA) for “the every-other-month 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.”

The approval marks the first approved GA treatment for Australia, where more than 75,000 individuals are currently living with the disease. While the figure represents a substantially smaller commercial market for the drug than the US, it nonetheless marks a significant milestone for the country, as well as for Apellis’ revenue growth.

Syfovre has continued to dominate the US GA treatment landscape since its FDA approval in February 2023, with Apellis announcing that approximately 160,000 total doses of the medication had been distributed throughout that year, accounting for around 95 percent of GA patients in the US. At the JP Morgan Healthcare Conference (San Francisco, CA) in January 2025, the company reported net product revenues of $709 million for 2024, of which Syfovre was said to have generated $611 million. This represents a 120 percent annual sales growth for the drug, with over 510,000 injections performed in the country in 2024 (up 215 percent from 2023).

It should be noted that while Syfovre has been shown to slow progression of GA by around 14-20 percent, it has not been proven to improve eyesight or restore vision in these patients. Moreover, there have been a number of side-effects reported with the drug, including instances of wet AMD development, blurred vision, inflammation, and “bleeding beneath the clear lining of the eye,” as well as 13 documented cases of retinal vasculitis.

In light of these safety profile concerns, the drug has since been rejected by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). While it recognized that the treatment could slow GA progression, the MHRA was unconvinced by the drug’s ability to meaningfully improve GA patients’ vision.

The UK charity, The Macular Society, has referred to the rejection as “a significant setback for those affected by GA, who have been waiting for progress in managing this challenging condition.” On September 20, 2024, the European Medicines Agency (EMA) also rejected Syfovre, following a re-examination of an earlier rejection, which led Apellis CEO Cedric Francois to comment, “We are deeply disappointed by this outcome, which leaves millions of Europeans with GA without a treatment for this irreversible form of blindness.”