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FDA grants Lucentis breakthrough therapy for diabetic retinopathy


The FDA has granted breakthrough therapy designation for Lucentis (ranibizumab, Genentech) for the treatment of diabetic retinopathy.

FDA has granted breakthrough therapy designation for Lucentis (ranibizumab, Genentech) for the treatment of diabetic retinopathy.

Read more about the breakthrough therapy designation

Diabetic retinopathy (DR) is a disorder of the retinal vasculature that occurs in patients with long-standing diabetes. Early on, DR is characterized by vascular occlusion and dilations and later progresses into proliferative retinopathy with the formation of new blood vessels.  DR eventually affects nearly all diabetes patients and can lead to blindness if left untreated.  

Lucentis is a humanized monoclonal antibody fragment which inhibits human vascular endothelial growth factor A (VEGF-A) from binding to its receptors thereby suppressing the growth of new blood vessels in the eye and effectively slowing vision loss.  The drug is available as an intravitreal injection and is only for use by ophthalmologists trained in the specialized administration techniques. 

Lucentis was previously granted priority review by FDA in October and its breakthrough therapy designation should further accelerate the approval process.

"Diabetes is the leading cause of vision loss in working aged Americans. Genentech has a strong commitment to patients with diabetic eye disease and we are gratified that FDA has recognized Lucentis with this breakthrough therapy designation in diabetic retinopathy," said Jason Ehrlich, MD, Genentech's group medical director of ophthalmology, in a press release.

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Lucentis is currently indicated for neovascular age-related macular degeneration, macular edema following retinal vein occlusion, and diabetic macular edema. If approved, Lucentis will be the first ocular medication approved for the treatment of DR, which currently affects 7.7 million Americans.

Erin Bastick is a PharmD Candidate 2016, Ohio Northern University, Ada, Ohio, and an inpatient intern at University Hospitals, Cleveland.

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