FDA approve ranizumab ocular implant (Susvimo) for Wet Age-Related Macular Degeneration (AMD)
Approval is based on results from Phase III Archway study primary analysis, which found Susvimo achieved and maintained vision gains equivalent to monthly ranibizumab injections – +0.2 and +0.5 eye chart letters from baseline, respectively – at weeks 36 and 40 of treatment.
Source:
Biospace Inc.
SPS commentary:
Susvimo, previously called Port Delivery System with ranibizumab, delivers ranizumab continuously into the eye through a refillable implant, which is surgically inserted into the eye during a one-time, outpatient procedure and refilled every six months, offering people living with wet AMD an alternative to anti-VEGF eye injections which may be needed as often as once a month. If necessary, supplemental ranibizumab treatment can be given to the affected eye while the Susvimo implant is in place .