FDA Approves Genentech’s Lucentis (Ranibizumab Injection)

Genentech, a member of the Roche Group, recently announced that the US FDA approved Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy (DR) in people with diabetic macular edema (DME). DME impacts nearly 750,000 Americans, about 10% of people with DR. The FDA granted Lucentis Breakthrough Therapy Designation and Priority Review for this indication based on results from the RISE and RIDE Phase III clinical trials.

“While there are various options for treating diabetic macular edema, before today none were approved showing improvement in retinopathy,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development. “With today’s approval, people with diabetic macular edema now have a FDA-approved medicine that showed meaningful improvements in retinal damage from diabetes, in addition to the established improvement in vision.”

Almost 29 million Americans have diabetes. The longer people have diabetes, especially if it is poorly managed, the higher their risk for developing DR. It is caused by elevated blood sugar levels damaging the fine blood vessels of the retina.

DR with DME is a common diabetic eye disease and a leading cause of blindness in American adults under 55. DR with DME can lead to conditions that threaten vision.
The FDA designates Breakthrough Therapy to a medicine if it is intended to treat a serious or life-threatening disease and if preliminary clinical research suggests it may provide substantial improvement on clinically significant endpoints over existing therapies.

The FDA grants Priority Review to medicines that, if approved, would have the potential to provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.
In 2012, Lucentis was the first medicine approved by the FDA for the treatment of DME. Lucentis has also been an important option for patients with wet age-related macular degeneration (wet AMD) since 2006 and macular edema following retinal vein occlusion (RVO) since 2010.

RISE and RIDE are two identically designed, parallel, double-masked, sham treatment-controlled trials in 759 patients with DR and DME at baseline who were randomized into three groups to receive monthly treatment with 0.3-mg Lucentis, 0.5-mg Lucentis, or sham injection. The primary outcome in RISE and RIDE was visual acuity gain at 24 months for DME patients.

The safety and efficacy of Lucentis for the treatment of DR with DME was assessed over 3 years in patients with baseline DR severity scores ranging from 10 to 75 in the study eye (on the ETDRS diabetic retinopathy severity scale). Secondary and exploratory outcomes were evaluated at 24 months. At month 24, a higher proportion of patients had observed a three-step or better improvement of their disease compared to sham, as determined by color fundus photography. The safety in the RISE and RIDE Phase III trials was consistent with previous studies.

In the third year of the studies, patients from the control group had the option to cross over to receive monthly treatment with 0.5-mg Lucentis; patients originally randomized to 0.3-mg or 0.5-mg Lucentis continued to receive the same dose, and all patients were followed for 12 additional months. The 0.3-mg dose of Lucentis is approved for both DME and for DR in people with DME.

Lucentis is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels.
Lucentis is FDA-approved for the treatment of wet AMD, macular edema following RVO, DME and DR in people with DME. Genentech has conducted eight key clinical trials with Lucentis. The medicine has been studied in 21 clinical trials worldwide in more than 9,080 patients.

Lucentis was developed by Genentech. The company retains commercial rights in the US, and Novartis has exclusive commercial rights for the rest of the world. Outside the US, Lucentis is approved in more than 100 countries to treat patients with wet AMD, for the treatment of DME, and due to macular edema secondary to both branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO).