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In a unanimous vote (10-0), an FDA advisory committee recommended approval of the 0.3-mg dose of ranibizumab injection (Lucentis, Genentech, a member of the Roche Group) for treatment of diabetic macular edema.
In a unanimous vote (10-0), an FDA advisory committee recommended approval of the 0.3-mg dose of ranibizumab injection (Lucentis, Genentech, a member of the Roche Group) for treatment of diabetic macular edema (DME).
FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) also recommended (8-2) approval of the 0.5-mg dose.
FDA is expected to make a decision regarding the supplemental Biologics License Application (sBLA) for ranibizumab injection in DME by August 10, 2012.
"The committee's recommendation is an important step towards the goal of helping to redefine the standard of care for Americans with diabetic macular edema," said Hal Barron, MD, chief medical officer and head, global product development, in a Genentech press release. "There has not been a major development in the treatment of DME for more than 25 years, and we look forward to the FDA’s decision."
DME is an eye condition in people with diabetes characterized by retinal swelling and blurred vision. It is a major cause of vision loss and blindness estimated to affect more than 560,000 people in the United States. The current standard of care for DME in the United States is laser surgery, which primarily serves to slow the progression of vision loss and help stabilize vision.
The DODAC recommendation was based on a review of data from Genentech's phase 3 trials, RIDE and RISE, which evaluated the efficacy and safety of ranibizumab in people with DME. The primary end point was the percentage of patients who could read an additional 15 letters or more on the standard eye chart after 24 months of treatment compared to the percentage in a control group.
RIDE and RISE are 2 identically-designed, parallel, double-masked, sham treatment-controlled trials in a total of 759 patients, who were randomized into 3 groups to receive monthly treatment with 0.3-mg ranibizumab, 0.5-mg ranibizumab or sham injection (control group). Primary outcomes were evaluated at 24 months. In the third year of the studies, patients from the control group had the option to cross over to receive monthly treatment with 0.5-mg ranibizumab; patients originally randomly assigned to 0.3-mg or 0.5-mg ranibizumab continued to receive the same dose, and all patients were followed for 12 additional months. In an ongoing open-label extension of RIDE and RISE, all patients are eligible to receive 0.5-mg ranibizumab as needed, and continue to be followed.
Ranibizumab was first approved by FDA for treatment of wet age-related macular degeneration (AMD) in 2006 and for macular edema following retinal vein occlusion (RVO) in 2010.
Some patients taking ranibizumab have had serious side effects related to the injection, such as serious intraocular infections, detached retinas, and cataracts. Other uncommon serious side effects include inflammation inside the eye and increased intraocular pressure (IOP). These can make a patient's vision worse. Some patients have increases in IOP within 1 hour of an injection. An ophthalmologist should check the IOP and eye health during the week after a ranibizumab injection.
Uncommonly, patients taking ranibizumab have had serious, sometimes fatal, problems related to blood clots, such as heart attacks or strokes. If a patient's eye becomes red, sensitive to light, painful, or there is a change in vision, patients should call or visit their ophthalmologist right away.
The most common side effects in the eye are increased redness in the whites of the eye, cataracts, and eye pain, small specks in vision, and the feeling that something is in the eye. The most common non-eye-related side effects are nose and throat infections, headache, joint pain, lung/airway infections, and nausea.