February 04, 2025
1 min learn
Key takeaways:
- The approval was supported by 1-year outcomes from the part 3 Pagoda research.
- Susvimo can be authorised for moist age-related macular degeneration.
The FDA authorised Susvimo for the therapy of diabetic macular edema, in accordance with a press launch.
The choice was supported by optimistic 1-year knowledge from the part 3 Pagoda research, wherein Susvimo (ranibizumab injection, Genentech) 100 mg/mL refilled each 6 months yielded sustained imaginative and prescient enhancements that have been noninferior to imaginative and prescient enhancements in those that acquired month-to-month intravitreal injections of 0.5 mg ranibizumab. As well as, security was per the identified profile for Susvimo.

The FDA authorised Susvimo for the therapy of DME.
Susvimo constantly delivers ranibizumab by way of the port supply platform and is the “first and solely FDA-approved therapy proven to keep up imaginative and prescient in individuals with DME with fewer therapies than standard-of-care eye injections,” the discharge stated.
That is the second indication for Susvimo, which can be authorised for the therapy of moist age-related macular degeneration.
“Susvimo presents a singular, handy therapy different to routine eye injections for individuals with a doubtlessly blinding diabetic eye situation,” Levi Garraway, MD, PhD, chief medical officer and head of world product growth at Genentech, stated within the launch. “As the worldwide prevalence of this situation continues to develop, immediately’s FDA approval for Susvimo displays our dedication to innovation and enhancing the affected person expertise.”