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On October 22, Roche announced that the FDA has approved its new drug delivery device Susvimo (Ranibizumab injection 100mg/ml) for the treatment of at least two anti-VEGF therapies for wet age-related macular degeneration (nAMD).
Susvimo, also known as the Port Delivery System with ranibizumab (Port Delivery System with ranibizumab), is a rice-sized eyeball implant device that is surgically implanted into the eye once, and then keeps ranibizumab in the eye.
nAMD is one of the common diseases that cause loss of central vision in humans, affecting approximately 20 million people worldwide, and is the main cause of blindness in people aged 60 and above
Anti-VEGF drugs have been developed for the treatment of nAMD for 15 years.
Susvimo is the first new treatment approved by the FDA to reduce the number of eyeball injections for nAMD patients to 2 times a year.
In the Phase III Archway study on which the approval was based, the visual acuity at the 36th week and the 40th week of the Susvimo drug delivery device was improved by 0.
In terms of safety, the most common adverse events of patients receiving Susvimo were conjunctival hemorrhage, conjunctival hyperemia, iritis, and eye pain.
In addition to improving the treatment experience of anti-VEGF, a standard care program for nAMD
From the biological mechanism, VEGF-A and Ang-2 signals can make blood vessels unstable, induce the formation of new blood vessels and promote inflammation
Faricimab is the first bispecific antibody developed for ophthalmic diseases.
