Roche/Genentech eye US diabetic retinopathy market for Lucentis
This article was originally published in Scrip
Roche subsidiary Genentech on 8 August said it had submitted a supplemental biologics application (sBLA) to the FDA seeking approval to market Lucentis (ranibizumab injection) as a treatment for diabetic retinopathy, the most common diabetic eye disease, affecting nearly 8 million Americans.
Diabetic retinopathy is the leading cause of new cases of blindness in working-age Americans.
The longer a person has diabetes, especially if it is poorly controlled, the higher their risk for developing diabetic retinopathy – with the eye condition eventually affecting nearly all diabetes patients.
Diabetic retinopathy is caused by changes in the blood vessels of the retina.
In its early stages, diabetic retinopathy is often without symptoms. But if left untreated, diabetic retinopathy can lead to blindness.
Lucentis, a vascular endothelial growth factor (VEGF) inhibitor, already is approved for three other indications: Neovascular, or wet age-related macular degeneration; macular edema following retinal vein occlusion and diabetic macular edema, which is a common complication associated with diabetic retinopathy.
Genentech's competitor Regeneron Pharmaceuticals' product Eylea (aflibercept), a fully human fusion protein, consisting of VEGF receptors 1 and 2, is approved for the same three indications.
So winning the diabetic retinopathy indication, for which there currently are no ocular medications approved, Lucentis would one-up Eylea.
The sBLA for Lucentis, which was first approved for the US market in 2006, was based on Genentech's Phase III RISE and RIDE clinical trials, two identically-designed, parallel, double-masked, sham treatment-controlled studies involving 759 patients with diabetic retinopathy and DME at baseline who were randomized into three groups to receive monthly treatment with 0.3mg or 0.5mg of Lucentis or a sham injection.
The safety and efficacy of Lucentis in diabetic retinopathy was assessed over three years in patients with baseline diabetic retinopathy severity scores ranging from 10 to 75 in the study eye on the ETDRS diabetic retinopathy severity scale.
At 24 months, a higher proportion of patients had observed a three-step improvement or better of their disease compared to sham, as determined by color fundus photography
In the third year of the studies, patients from the control group had the option to cross over to receive monthly treatment with 0.5mg of Lucentis.
Patients in the trial originally randomized to 0.3mg or 0.5mg Lucentis continued to receive the same dose, and all study participants were followed for 12 additional months.