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FDA approves Syfovre for geographic atrophy in advanced age-related macular degeneration

In a press release from the manufacturer Apellis Pharmaceuticals, syfovre (pegcetacoplan), is the first FDA approved therapy for geographic atrophy secondary to age-related macular degeneration which is a leading cause of blindness.

Geographic atrophy (GA) is an advanced form of age-related macular degeneration and which leads to progressive and irreversible loss of vision. Age-related macular degeneration is a common condition with one US analysis suggesting an annual incidence of 3.5 per 1,000 individuals, around 293,000 new cases per year in those 50 years of age and older. Globally, the condition is estimated to affect some 5 million people and the median time to the development of central GA following any GA diagnosis is 2.5 years, with an average visual acuity decrease of 22 letters after 5 years.

The complement system is a component of the immune system that is central to the detection and destruction of invading pathogens and consists of three pathways. Moreover, dysregulation of this system is thought to be implicated in the development of age-related macular degeneration. Syfovre is a complement C3 inhibitor (i.e., one of these pathways) and data from a phase 2 trial showed that the drug produced significant reductions in the growth of GA compared to sham treatment.

Syfovre phase 3 clinical studies

The approval of syfovre was based on the data from two trials, OAKS and DERBY, both of which were randomised, sham trials of 24 months duration and where syfovre (15 mg/0.1ml) was administered either monthly or every other month. The results showed that in OAKS, monthly syfovre treatment reduced the rate of GA growth by 22% and by 18% when used every other month. Similarly, data from DERBY observed a 18 and 17% reduction in GA growth rate for monthly and alternate monthly injections respectively. Further details on the product can be found in the full prescribing information sheet.

According to the press release, syfovre is currently under review by the European Medicines Agency with a decision expected in early 2024.






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