Susvimo implant for Wet AMD Voluntarily Recalled

Susvimo, previously called Port Delivery System with ranibizumab (Lucentis), was FDA-approved on October 21, 2021, for intravitreal use via ocular implant for the treatment of people with wet (neovascular) age-related macular degeneration (AMD). Now, one year later, Genentech has announced that it is voluntarily recalling the implant and the insertion tool in the U.S. As [Read More]

Long-awaited Faricimab for wet AMD and DME approved

The FDA has approved Genentech’s Vabysmo (first announced here as faricimab), the only injectable eye medicine approved simultaneously in the U.S. for wet age-related macular degeneration (AMD) and diabetic macular edema (DME). Vabysmo will be administered using flexible dosing regimens based on patient need. The medication targets and inhibits two disease pathways by neutralizing angiopoietin-2 [Read More]

FDA Approves First Biosimilar Drug for Treatment of Wet AMD

The U.S. Food and Drug Administration (FDA) has approved Byooviz (ranibizumab-nuna) as the first biosimilar to Lucentis (ranibizumab injection) for the treatment of wet AMD. Byooviz is also approved to treat macular edema and myopic choroidal neovascularization, a vision-threatening complication of myopia (nearsightedness). The drug is administered by intravitreal injection (delivered into the vitreous humor [Read More]