Genentech announced that the FDA has approved Lucentis (ranibizumab) 0.3 mg for the monthly treatment of all forms of diabetic retinopathy. With this approval, Lucentis becomes the first and only FDA-approved medicine to treat diabetic retinopathy in people who have been diagnosed either with or without diabetic macular edema (DME). In February 2015, Lucentis received FDA approval for the treatment of diabetic retinopathy in people with DME based on data from the pivotal RIDE and RISE phase 3 clinical trials.
The FDA granted Lucentis priority review for the treatment of diabetic retinopathy without DME based on an analysis of the Diabetic Retinopathy Clinical Research Network’s (DRCR.net) Protocol S study. This NIH-funded study compared Lucentis treatment to panretinal laser treatment in diabetic retinopathy patients both with and without DME. In the analysis that supported this approval, patients with and without DME in the Lucentis group experienced improvements in the severity of their retinopathy. Adverse events were consistent with those seen in previous studies.
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“Diabetic retinopathy is the leading cause of vision loss among working-aged adults in the US between the ages of 20 and 74. We are very pleased that Lucentis is now FDA-approved to treat retinopathy in people with and without DME,” Sandra Horning, MD, chief medical officer and head of Global Product Development, said in a company news release. “In multiple clinical studies, Lucentis demonstrated a significant improvement of patients’ diabetic retinopathy, and it is the first and only anti-VEGF therapy approved to treat all forms of diabetic retinopathy.”
Priority review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the safety and effectiveness of the treatment of a serious disease. The FDA previously granted Lucentis breakthrough therapy designation for diabetic retinopathy in 2014 based on the RIDE and RISE phase 3 clinical trials. Breakthrough designation is intended to expedite the development and review of medicines with early evidence of potential clinical benefit in serious diseases and to help ensure that patients receive access to medicines as soon as possible.
About Protocol S
The Diabetic Retinopathy Clinical Research Network’s (DRCR.net) Protocol S study was a randomized, active-controlled study comparing Lucentis to a type of laser therapy called panretinal or scatter photocoagulation (PRP) in 305 patients with proliferative diabetic retinopathy, including those with and without diabetic macular edema (DME). In the Lucentis group, patients received a baseline 0.5 mg intravitreal injection followed by three monthly intravitreal injections, after which treatment was guided by prespecified retreatment criteria.
In the analysis that supported the approval, 37.8 percent (n=56/148) of patients in the Lucentis group without baseline DME had a two-step or better improvement in their diabetic retinopathy and 28.4 percent (n=42/148) had a three-step or better improvement at two years, according to the Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale (ETDRS-DRSS). In Lucentis-treated patients with baseline DME, 58.5 percent (n=24/41) had a two-step or better improvement in their diabetic retinopathy and 31.7 percent (n=13/41) had a three-step or better improvement at two years. Adverse events were similar to those seen in other Lucentis trials.
The DRCR.net is funded by the National Eye Institute, part of the National Institutes of Health. The DRCR.net is a collaborative network dedicated to facilitating multicenter clinical research of diabetic retinopathy, DME and associated conditions, and supports the identification, design and implementation of multicenter clinical research initiatives focused on diabetes-induced retinal disorders. The DRCR.net was formed in September 2002 and currently includes over 115 participating sites with over 400 physicians throughout the U.S. The Protocol S study was supported, in part, by Genentech as part of the company’s ongoing commitment to supporting independent research and collaboration to advance science.