Ansetolimod (ALPMY.US), a complement C5 inhibitor, has been approved by the FDA for market launch.

On February 13, Alcon (ALPMY.US) announced that the FDA has approved Izervay (avacincaptad pegol) for the supplemental new drug application (sNDA) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). With this approval, there is no longer any limitation on the duration of Izervay administration, providing greater flexibility for doctors and patients to manage GA. Based on the two-year results of the Phase III GATHER2 study, Alcon's sNDA application extended the dosing interval of Izervay and reduced its dosing frequency. Izervay was FDA approved for commercialization in August 2023 for the treatment of AMD secondary to GA, with the approved dosing regimen being once monthly for up to one year. In the GATHER1 study, compared to the placebo group, the average growth rate of GA lesion area decreased by 27.38% (p=0.0072) and 27.81% (p=0.0051) for patients in the 2mg and 4mg dose groups of Izervay, respectively.