FDA approves Susvimo for diabetic macular edema
Key takeaways:
- The approval was supported by 1-year results from the phase 3 Pagoda study.
- Susvimo is also approved for wet age-related macular degeneration.
The FDA approved Susvimo for the treatment of diabetic macular edema, according to a press release.
The decision was supported by positive 1-year data from the phase 3 Pagoda study, in which Susvimo (ranibizumab injection, Genentech) 100 mg/mL refilled every 6 months yielded sustained vision improvements that were noninferior to vision improvements in those who received monthly intravitreal injections of 0.5 mg ranibizumab. In addition, safety was consistent with the known profile for Susvimo.
Susvimo continuously delivers ranibizumab through the port delivery platform and is the “first and only FDA-approved treatment shown to maintain vision in people with DME with fewer treatments than standard-of-care eye injections,” the release said.
This is the second indication for Susvimo, which is also approved for the treatment of wet age-related macular degeneration.
“Susvimo presents a unique, convenient treatment alternative to routine eye injections for people with a potentially blinding diabetic eye condition,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech, said in the release. “As the global prevalence of this condition continues to grow, today's FDA approval for Susvimo reflects our dedication to innovation and enhancing the patient experience.”
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