Roche Reports the US FDA’s Approval of Susvimo to Treat Diabetic Macular Edema (DME)
Shots:
- The US FDA has approved Susvimo (port delivery platform with Lucentis) to treat DME
- Approval was based on P-III (Pagoda) study assessing Susvimo (100 mg/mL, refilled in Q6M) vs Lucentis (0.5mg, intravitreal, Q1M) in DME pts (n=634), where subjects in Susvimo arm received 4 loading doses of Lucentis till 16wks. prior to implantation
- Study demonstrated sustained vision improvements with 9.6 vs 9.4 letters on eye chart, showing non-inferiority of Susvimo
Ref: Roche | Image: Roche
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