2-Year Data from Genentech AMD/DME Drugs Reinforce Relief
New two-year data from Phase III studies of Susvimo (previously named Port Delivery System with ranibizumab) and Vabysmo (faricimab) are reinforcing the two drugs’ potential to improve the quality of life for patients diagnosed with diabetic macular edema (DME) and neovascular or wet age-related macular degeneration (nAMD).
Wet AMD and DME are two leading causes of vision loss among adults in the U.S. and together affect around 40 million people worldwide. Current standard treatments involve getting eye injections as often as once per month.
The U.S. Food and Drug Administration approved Vabysmo as a prescription treatment for wet AMD and DME in January 2022. The drug is the only FDA-approved injectable eye medicine for both diseases that improves and maintains vision through injections administered one to four months apart.
Vabysmo’s approval was based on positive results from two studies, RHINE and YOSEMITE, which covered a total of 1,891 people living with either disease. The drug works by inhibiting disease pathways commonly linked to vision loss.
In the latest two-year data to be presented at the Angiogenesis, Exudation and Degeneration 2022 conference on February 12, Genentech will show at least 60% of those who qualified for extended Vabysmo dosing could be treated every four months at two years. Almost 80% of them could also be treated every three months or longer.
In addition, the company will be showcasing results from the Susvimo Archway study, demonstrating the drug’s ability to have patients with wet AMD go for six months between treatments at two years.
Susvimo, administered as 100 mg/mL eye injections almost monthly through a refillable implant, is the first wet AMD therapy in 15 years to offer an alternative to standard-of-care injections. To date, it is the only FDA-approved treatment that can reduce the frequency of injections to just two per year. It is allowed for use in wet AMD patients who have previously responded to two or more anti-VEGF injections.
“Results from these studies reinforce the potential of Vabysmo and Susvimo to redefine standards of care and reduce treatment burden for people living with diabetic macular edema and wet AMD. These two first-of-their-kind treatments are the culmination of over a decade of pioneering research, aiming to better address the needs of people with retinal conditions,” said Levi Garraway, M.D., Ph.D., the chief medical officer and head of global product development at Genentech, said in a statement.
Besides the FDA, the European Medicines Agency is reviewing Vabysmo for both DME and wet AMD, as well as Susvimo for wet AMD. Genentech, a member of the Roche Group, has also submitted applications to other regulators worldwide.