FDA Approves Implantable Tx for AMD – Susvimo

The FDA approved a new therapy, Susvimo (ranibizumab injection) from Genentech, indicated for intravitreal use via ocular implant for wet age-related macular degeneration (AMD) with at least two prior anti-vascular endothelial growth factor (VEGF) injections. The implant is surgically inserted into the eye during a one-time, outpatient procedure and can be refilled every six months.

Wet AMD impacts approximately 1.1 million people in the United States and is a leading cause of blindness in people aged 60 and older. Age-related macular degeneration (AMD) is a condition that affects the macula, the part of the eye that provides sharp, central vision. AMD is an advanced form of the disease that can cause rapid and severe vision loss. Approximately 11 million people in the United States have some form of AMD.

Genentech developed the first anti-VEGF medicine, Lucentis (ranibizumab injection), approved for wet AMD by the FDA in 2006. Susvimo, however, is different from the ranibizumab intravitreal injection.

Pricing for Susvimo was not released. By way of reference, Lucentis costs approximately $2,000 / month and is administered monthly….. so upwards of $24,000 annually. Analysts believe that Susvimo will generate more than $1 billion in 2022 sales. The 2020 AMD market in the US generated more than $35 billion in sales.
Distribution details on were not released. However, virtually all other therapies for AMD and other high-cost Ophthalmology injectable therapies are currently in limited distribution, direct-to-provider, via specialty pharmacies.
Susvimo will be available in the United States later this quarter.

CLICK HERE to access the full Genentech press release.

FDA Approves Genentech’s Susvimo, a First-of-Its-Kind Therapeutic Approach for Wet Age-Related Macular Degeneration (AMD)

Susvimo, previously called Port Delivery System with ranibizumab, is the first wet AMD treatment in 15 years to provide an alternative to standard-of-care eye injections needed as often as once a month
By continuously delivering medicine into the eye through a refillable implant, Susvimo may help people with wet AMD maintain their vision with as few as two treatments per year

October 22, 2021 — Genentech, a member of the Roche Group, today announced that the U.S. 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 wet, or neovascular, age-related macular degeneration (AMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections. Wet AMD is a potentially blinding condition that requires treatment with eye injections as often as once a month. Susvimo, previously called Port Delivery System with ranibizumab, is the first and only FDA-approved treatment for wet AMD that offers as few as two treatments per year.

“Susvimo represents a major advancement in the treatment of retinal disease and is an important new option for patients with wet AMD,” said Carl Regillo, M.D., Chief of Retina Service at Wills Eye Hospital in Philadelphia and an Archway study investigator. “With Susvimo, my patients now have an option that can help them maintain their vision as well as anti-VEGF injections, but on a more manageable twice-yearly treatment schedule.”

Susvimo delivers ranibizumab continuously, offering people living with wet AMD an alternative to anti-VEGF eye injections needed as often as once a month

The approval is based on positive results from the Phase III Archway study primary analysis, which showed wet 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. In addition, 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.

Genentech is committed to helping people access the medicines they are prescribed and will be offering comprehensive services for people prescribed Susvimo to help minimize barriers to access and reimbursement. Patients can call 833-EYE-GENE for more information. For people who qualify, Genentech plans to offer patient assistance programs through Genentech Access Solutions. More information is also available at (866) 4ACCESS/(866) 422-2377 or http://www.Genentech-Access.com.

Genentech’s late-stage ophthalmology portfolio also includes faricimab, a bispecific antibody under FDA and EMA review for the treatment of wet AMD and DME. The FDA is additionally reviewing faricimab for the treatment of diabetic retinopathy.

Press release continues…………


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