US regulators are undertaking a speedy review of Genentech's eye drug Lucentis for the treatment of myopic choroidal neovascularisation (mCNV), a complication of severe near-sightedness that can lead to blindness.
The move could see Lucentis (ranibizumab) become the first anti-vascular endothelial growth factor (VEGF) therapy approved by the US Food and Drug Administration to treat mCNV.
The filing is based on data from the Phase III RADIANCE study, which showed that treatment with Lucentis provided superior visual acuity gains in people with the condition compared to verteporfin photodynamic therapy (vPDT), the only treatment currently approved for mCNV.
In the study, patients were randomised into three treatment groups: 106 patients in group I received Lucentis on study day I, as well as one month later, and as needed thereafter; 116 patients in group II were given the drug on study day 1 and as needed thereafter; 55 patients in group III were treated with vPDT on study day 1 and then received treatment with Lucentis or vPDT after month three.
After three months, the Lucentis groups I and II gained 10.5 and 10.6 letters in visual acuity, respectively, showing a statistically significant improvement over the vPDT group III, which gained 2.2 letters.
Treatment with both Lucentis and vPDT was generally well-tolerated, with low incidences of ocular (0.7 percent) and non-ocular (4.0 percent) serious adverse events reported in groups I and II, and none in group III, the firm said.
"Currently, the FDA-approved treatment option for myopic CNV only stabilizes vision for patients temporarily," said John A. Wells III, a retina specialist at the Palmetto Retina Center and chairman of the Department of Ophthalmology at the Palmetto Health-USC Medical group in Columbia, SC.
"If approved, Lucentis could be an important tool in helping these patients improve vision."