Genentech Diabetic Macular Oedema Drug Meets Primary Endpoint

28 March 2011 (Last Updated March 28th, 2011 18:30)

Genentech has reported that (ranibizumab injection) has met the primary endpoint of the second of two Phase III trials, which evaluated it in patients with diabetic macular oedema. The study revealed that, after 24 months, a significantly greater number of patients who received Lucenti

Genentech has reported that (ranibizumab injection) has met the primary endpoint of the second of two Phase III trials, which evaluated it in patients with diabetic macular oedema.

The study revealed that, after 24 months, a significantly greater number of patients who received Lucentis were able to read 15 additional letters on an eye chart than they could at the beginning of the study, compared to those who received placebo injections.

At 24 months, 33.6% of patients who received 0.3mg Lucentis and 45.7% of patients who received 0.5mg Lucentis were able to read 15 more letters on the eye chart than they could read at the start of the study, compared to 12.3% of patients who received sham injections.

Key secondary endpoints, which included average eye chart reading scores over time and changes in retinal swelling, met statistical significance.

The safety results were consistent with previous Lucentis Phase III trials and no new significant safety findings were observed.

The multicentre, randomised, double-masked, sham injection-controlled, Phase III study was designed to assess the efficacy and safety profile of Lucentis in 382 patients with diabetic macular oedema.

Patients were randomised to receive monthly injections of either 0.3mg Lucentis, 0.5mg Lucentis or sham injections.

Diabetic macular oedema is an eye condition characterised by swelling of the retina, which can occur in patients with type 1 or type 2 diabetes and can lead to blurred vision, severe vision loss and blindness.