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Roche Reports the US FDA’s Approval of Susvimo to Treat Diabetic Retinopathy

Shots:

  • The US FDA has approved Susvimo (port delivery platform with Lucentis) for the treatment of diabetic retinopathy (DR)
  • Approval was based on 1 yr. P-III (Pavilion) trial data assessing Susvimo (100mg/mL, refilled Q9M) vs monthly clinical observation in 173 pts with non-proliferative DR without center-involved DME, where subjects in Susvimo arm received 2 loading doses of intravitreal Lucentis prior to implantation at Wk. 4   
  • Trial showed superior DRSS improvements, demonstrating reduced eye damage caused by diabetes without the need of a supplemental treatment at 1yr.

Ref:  Globenewswire| Image: Roche| Press Release

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