FDA Breakthrough Therapy Designation #59: Genentech And Diabetic Retinopathy

Orphan Druganaut Blog

Genentech, receives this week the FDA Breakthrough Therapy (BTD) for Lucentis (Ranibizumab Injection) for diabetic retinopathy. Lucentis, given by injection into the eye, has FDA approval for the following indications :

•    Diabetic Macular Edema (DME)

•    Neovascular (wet) Age-Related Macular Degeneration (AMD)

•    Macular edema following Retinal Vein Occlusion (RVO).

Diabetic retinopathy is a complication of diabetes that results in damaging the eye’s retina, that can lead to poor vision, vision loss, and other vision problems. There is currently no FDA approved treatment for diabetic retinopathy.

According to an online EyeWireToday article, for Genentech’s Lucentis the FDA :

•    In September 2014, accepts a supplemental Biologics License Application (sBLA) & grants Priority Review for diabetic retinopathy

•    Confirmed action date for the BLA is 02/06/14.

In September 2014, Regeneron Pharmaceuticals receives the FDA BTD for Eylea (Afibercept) injection for the same indication. Eylea is currently approved in the…

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