FDA panel unanimously recommends ranibizumab injection for DME

Silver Spring, MD-An FDA advisory committee has unanimously recommended approval of the 0.3-mg dose of ranibizumab injection (Lucentis, Genentech) for the treatment of diabetic macular edema (DME), in a 10 to 0 vote.

The agency’s Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) also recommended approval of the 0.5-mg dose in an 8 to 2 vote.

The FDA is expected to make a decision regarding the supplemental biologics license application for ranibizumab injection in DME by Aug. 10.

“The committee’s recommendation is an important step toward 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 of global product development for Genentech. “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.”

The DODAC recommendation was based on a review of data from Genentech’s phase III trials, RIDE and RISE, which evaluated the efficacy and safety of ranibizumab in people with DME. The primary endpoint 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 with the percentage in a control group.

RIDE and RISE are two identically designed, parallel, double-masked, sham treatment-controlled trials in a total of 759 patients who were randomly assigned to one of three 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 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 they continue to be followed.

Ranibizumab was first approved by FDA for treatment of wet age-related macular degeneration in 2006 and for macular edema following retinal vein occlusion 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 IOP. Some patients have increases in IOP within 1 hour of an injection. Ophthalmologists are advised to check 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. The most common side effects in the eye are increased redness in the whites of the eye, cataracts, 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.

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