Swiss drugmaker Novartis' eye drug Lucentis has been approved by European regulators as a treatment for vision loss in patients with diabetes, offering a novel approach to treating the condition.
The European Medicines Agency has OK'd the use of Lucentis (ranibizumab) - which is widely cleared around the globe as a therapy for wet age related macular degeneration - in patients with visual impairment due to diabetic macular edema (DME), which, as Novarits notes, is a leading cause of blindness in people of working-age in most developed countries.
The decision means that the drug has become the first licensed therapy to improve vision and quality of life in patients with DME, and is based clinical data showing a "rapid, superior and sustained" improvement compared to standard laser therapy, which can stabilise the deterioration of sight but is not really known to actually improve it, the company said.
"In the clinical trials, Lucentis-treated patients began to recover their vision as early as eight days after the first injection on average, and vision improvement was maintained at one year," noted Professor Gabriele Lang, Professor from Ulm's University Eye Hospital in Germany. "The vision improvement for many of these patients was clinically significant, meaning that they regained the ability to carry out day-to-day activities such as driving."
The data underpinning the drug's approval were garnered from two clinical trials sponsored by Novartis. The RESTORE study showed patients given Lucentis either alone or in combination with laser therapy gained 6.8 letters and 6.4 letters, respectively, in visual acuity following 12 months of treatment compared to baseline, while those treated with laser gained an average of 0.9 letters (as measured on a standard eye chart).
In addition, the RESOLVE study showed that patients treated with Lucentis gained an average of 10.3 letters in visual acuity after a year while 'sham-treated' patients, some of whom were also given laser therapy, lost an average of 1.4 letters.
Lucentis is an antibody fragment injected into the eye to neutralise vascular endothelial growth factor (VEGF), the protein responsible for increasing vascular permeability and thus capillary leakage and macular edema in patients with diabetes, and according to Novartis "offers an entirely new pharmacological approach to treatment for visual impairment due to DME compared to the current standard of care".
Novartis is also seeking approval to market the drug - sales of which shot up 19% to $398 million in the third quarter - to treat visual impairment due to macular oedema secondary to retinal vein occlusion in Europe, an indication which has already been given a green light by the US Food and Drug Administration.