The U.S. Food and Drug Administration has approved the use of once-monthly 0.3-mg intravitreal ranibizumab for the treatment of diabetic macular edema, according to a press release from Genentech.
Lucentis (ranibizumab, Genentech) is the only medicine approved by the FDA for diabetic macular edema (DME), the release said.
The 0.3-mg dose of ranibizumab was unanimously recommended for approval on July 26 by the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee. Intravitreal ranibizumab has already been approved by the FDA for the treatment of wet age-related macular degeneration and macular edema following retinal vein occlusion.
In clinical trials, 759 patients were given a 0.3-mg dose of ranibizumab, a 0.5-mg dose of ranibizumab or a sham injection.
Patients who received the 0.3-mg dose demonstrated significant improvements in vision as soon as 7 days after treatment, with more ranibizumab-treated patients than control subjects experiencing an increase in vision of three lines or more by month 24, according to the release. Patients also experienced sustained visual acuity from baseline through 24 months, with continued treatment through 36 months.
The most common ocular adverse events associated with the 0.3-mg injection vs. the sham injection were conjunctival hemorrhage, eye pain, foreign body sensation in the eye, vitreous floaters and increased IOP.
“Diabetes is a major public health issue in our country, and all patients with diabetes are at risk of developing diabetic macular edema,” Renata Albrecht, MD, director of the Division of Transplant and Ophthalmology Products in the FDA’s Center for Drug Evaluation and Research, said in an FDA press release. “Today’s approval represents a major development for the treatment of people whose vision is impaired by DME as a complication of their disease.”