Lucentis boosted by diabetic vision study
pharmafile | May 24, 2010 | News story | Research and Development, Sales and Marketing | AMD, DME, Lucentis, Novartis
A phase III trial of Novartis’ ranibizumab has shown it to be superior at promoting vision gain in patients with diabetic macular edema compared with laser treatment alone.
Ranibizumab is currently approved for the treatment of wet age-related macular degeneration (AMD) and marketed as Lucentis.
A marketing authorisation for a new indication in diabetic macular edema (DME) was submitted to European regulators in December 2009.
The results of the phase III RESTORE study show at year one that 37% of patients treated with ranibizumab 0.5 mg alone, and 43% of those treated in combination with laser treatment, gained a vision improvement of 10 letters or more on an eye-chart compared to 16% of patients treated with laser alone.
“Ranibizumab was specifically designed and licensed for use in the eye, and has already been shown in robust, randomised-controlled trials to improve vision and vision-related quality of life in patients with wet AMD,” said Trevor Mundel, global head of development at Novartis.
He added: “We are committed to exploring its potential in other ophthalmic diseases where there is an unmet medical need, and these results confirm that it could provide an important new therapeutic option for visually impaired patients with DME.”
The RESTORE trial was presented at the meeting of the European Association for the Study of Diabetic Eye Complications (EASDec) in Paris last week. The study was a randomised, double-masked, multi-centre trial that involved 345 DME patients with an average age of 63 years randomised into three treatment arms: ranibizumab 0.5 mg plus sham laser treatment; ranibizumab plus active laser treatment and sham injection plus active laser treatment.
The primary endpoint was the mean change in best-corrected visual acuity (BCVA) from baseline to the average level from months one to twelve. Key secondary endpoints were the mean change in BCVA over time, and safety, both of which were met.
Ranibizumab works by neutralising a protein called vascular endothelial growth factor (VEGF) that is believed to cause abnormal blood vessel growth and leakage beneath the macula.
Visual impairment due to diabetic macular edema (DME) affects 1–3% of diabetics worldwide and is a rare but serious complication of diabetes that can lead to significant vision loss.
In January the company expanded its eye health operations, acquiring Alcon eye care and creating a new Novartis division that incorporates CIBA Vision and a number of Novartis’ ophthalmic medicines.
Ben Adams
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