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Friday / June 14.
Homeminewsn-AMD Ocular Implant FDA Approved

n-AMD Ocular Implant FDA Approved

A twice yearly treatment schedule of Susvimo, delivered via a refillable ocular implant, may provide an important new option for patients with neovascular age-related macular degeneration (n-AMD).

The United States Food and Drug Administration (FDA) has approved Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of people with n-AMD who have previously responded to at least two antivascular endothelial growth factor (VEGF) injections.

Developed by Genentech (a member of the Roche Group), this is the first and only FDA-approved treatment for n-AMD that offers as few as two treatments per year.

Susvimo delivers ranibizumab continuously, offering people living with n-AMD an alternative to anti-VEGF eye injections needed as often as once a month. The implant is surgically inserted into the eye during a one-time, outpatient procedure and refilled every six months. If necessary, supplemental ranibizumab treatment can be given to the affected eye while the Susvimo implant is in place.

The approval is based on positive results from the Phase III Archway study primary analysis, which showed n-AMD patients treated with 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. Additionally, only 1.6% of Susvimo patients received supplemental ranibizumab treatment before their first refill, and more than 98% could go six months before their first refill. While generally well-tolerated, with a favourable benefit-risk profile, the implant has been associated with a three-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab.