First drug to treat dry AMD approved for use in US

Posted: Tuesday 21 February 2023

The first ever drug to treat dry age-related macular degeneration (AMD) has been approved for use in the US.

The Food and Drug Administration (FDA) has cleared the drug pegcetacoplan, known as Syfovre, for use in patients.

The drug, which has been developed by Apellis Pharmaceutcials, has been found in clinical trials to slow the progression of dry AMD and will be administered as an injection in the eye once every 25 to 60 days.

However, while this is good news for patients who do not currently have anything to treat their condition, there are question marks over how much of a benefit this treatment could have overall for those living with dry AMD. Those treated in the trials did not see any effect on their vision and had a slightly higher risk of developing wet AMD compared to those who received a placebo.

Geraldine Hoad, research manager at the Macular Society, said: “This development in the US is a huge milestone for patients living with dry AMD, who up to this point have not had any treatment available for their condition.

“However, it remains to be seen how much of a benefit this treatment could be for patients overall.

“We hope to have a clearer picture over the coming months and more hope to offer patients diagnosed with this devastating condition.”

Syfovre is expected to be available in the US by the beginning of March 2023. Meanwhile Apellis is making a submission to the Medicines and Healthcare products Regulatory Agency (MHRA), the process to approve the drug for use in the UK.

The Macular Society will be providing further updates when they become available.

Meanwhile, Iveric Bio has submitted a New Drug Application (NDA) for its drug Zimura to treat dry AMD, to the US Food and Drug Administration (FDA). They expect to hear back in August.

The drug acts as a blocker of a particular protein (C5), which is thought to play a key role in the advancement of the condition.

Scientists have reported that Zimura decreases the activity which leads to degeneration of retinal cells and can slow the progression of late-stage dry AMD.

Stay up to date with developments on this new drug and further progress in research by signing up to the Macular Society’s enewsletter or follow the Macular Society on Facebook and Twitter.