Lucentis receives FDA approval for treating diabetic macular oedema

Use of the diabetic eye drug Lucentis has been extended in the US after the country’s health regulator approved it for treatment of diabetic macular oedema (DMO), a sight-threatening complication of type 1 and type 2 diabetes.
San Francisco-based biotech Genentech, a subsidiary of Swiss drugmaker Roche, announced on Friday that the US Food and Drug Administration (FDA) has given the green light for ranibizumab (Lucentis) to be used once a month by patients diagnosed with DMO who have good blood sugar control.
The decision was based on data from clinical trials which showed “rapid substantial visual gain” for many patients with this severe eye condition. Between 34 per cent and 45 per cent of patients who received a monthly 0.3-mg injection of Lucentis gained at least three lines of vision on a standard eye chart after two years, compared with 12 per cent to 18 per cent of those in the untreated control group.
Higher 0.5 mg per doses were also tested but the FDA noted that “no additional benefit was observed”.
Lucentis, which is already approved for treatment of wet age-related macular degeneration in the US, has now become the first and only FDA-approved drug treatment for diabetic macular oedema, for which the first line of treatment to date has been laser eye surgery.
Developed by Genentech, the medicine is marketed in the United States by the Roche subsidiary and elsewhere by multinational pharmaceutical company Novartis .
Diabetic macular oedema occurs when excess blood sugar levels cause fluid and protein deposits to leak onto the macula (the central part of the retina). The resulting thickening and swelling of the macula can distort a person’s central vision, and if left untreated, can lead to severe vision loss or even blindness.