FDA Approves Injection to Treat All Forms of Diabetic Retinopathy

Ranibizumab can now treat patients with all forms of diabetic retinopathy.

The US Food and Drug Administration (FDA) has granted ranibizumab injection (Lucentis/Genentech) 0.3mg approval for the monthly treatment of all different forms of diabetic retinopathy — the most common cause of vision loss in patients with diabetes and the leading cause of blindness among adults 20-74 years.

This is the second FDA approval for Lucentis this year; in January, it became the first approved treatment for myopic choroidal neovascularization (mCNV) in the United States.

However, Lucentis had previously been approved in February 2015 to treat diabetic retinopathy in patients with diabetic macular edema (DME) based on data from two phase 3 clinical trials: RIDE and RISE.

According to researchers, Lucentis is a vascular endothelial growth factor (VEGF) inhibitor that is designed to inhibit VEGF-A, a protein believed to be critical in the formation of new blood vessels (angiogenesis) and the hyperpermeability of the vessels.

The initial Priority Review was based on an analysis by an NIH-funded Diabetic Retinopathy Clinical Research Network’s (DRCR.net) Protocol S study. The randomized, active-controlled study compared Lucentis treatment to a laser therapy called panretinal laser or scatter photocoagulation (PRP) in 305 diabetic retinopathy patients both with and without DME.

The patients in the Lucentis group were given a baseline 0.5mg intravitreal injection followed by 3 monthly intravitreal injections. Treatment was later guided by pre-specified re-treatment criteria.

According to an accompanying analysis, patients both with and without DME who were administered Lucentis had experienced significant “improvements in the severity of their retinopathy.”

The reports showed that 37.8% (n=56/148) of patients in the Lucentis group without baseline DME had a “2-step or better improvement in their diabetic retinopathy.” Also, 28.4% patients (n=42/148) experienced a “3-step or better improvement at 2 years.”

Sandra Horning, MD, chief medical officer and head of the Global Product Development, said in a news release, “In multiple clinical studies, Lucentis demonstrated a significant improvement of patents’ diabetic retinopathy, and it is the first and only anti-VEGF therapy approved to treat all forms of diabetic retinopathy.”

Lucentis is approved in more than 110 countries outside the US to treat patients with wet AMD, DME, branch retinal vein occlusion (BRVO), central retinal vein occlusion (CRVO), and visual impairment due to choroidal neovascularization.

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