Roche: FDA approves treatment for DME

(CercleFinance.com) - Roche announced that the US FDA has approved Susvimo® (ranibizumab injection) 100 mg/mL for the treatment of diabetic macular edema (DME).


DME is one of the leading causes of vision loss in adults with diabetes, affecting over 29 million adults worldwide.

Susvimo is the first and only FDA-approved treatment shown to maintain vision in people with DME with fewer treatments than standard eye injections. Susvimo is now available to US retina specialists and their patients with DME.

The FDA's decision was based on the positive one-year results of the Phase III Pagoda study. DME sufferers who received Susvimo renewed every six months achieved non-inferior improvements in vision compared with those receiving monthly intravitreal injections of 0.5 mg ranibizumab.

Susvimo provides a unique and convenient therapeutic alternative to routine eye injections for people with potentially blinding diabetic eye disease, said Levi Garraway, MD, PhD, Roche's Medical Director and Head of Global Product Development.


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