Genentech reports that two Phase III studies of Lucentis® in macular edema due to retinal vein occlusion (RVO) showed that, on average, patients had a clinically and statistically significant improvement in vision. This improvement, the primary endpoint, was measured by mean change from baseline in best-corrected visual acuity (BCVA) at six months compared to patients receiving placebo injections.
Lucentis is a vascular endothelial growth factor inhibitor approved by the FDA for the treatment of neovascular AMD at a dose of 0.5 mg monthly by intravitreal injection. The drug is designed to inhibit VEGF-A, a protein that is believed to play a critical role in angiogenesis and the hyperpermeability of the vessels. In RVO, angiogenesis and hyperpermeability can lead to macular edema, the swelling and thickening of the macula, which is the portion of the eye responsible for fine, detailed central vision.
The BRAVO study was conducted in patients with branch-RVO. It showed that at month six, patients who received 0.3 mg of Lucentis had a mean gain from baseline BCVA of 16.6 letters, and patients who received 0.5 mg of Lucentis had a mean gain of 18.3 letters. Patients in the placebo group had a mean improvement of 7.3 letters.
The CRUISE study, performed in central-RVO patients, demonstrated that at month six, patients who received 0.3 mg of Lucentis had a mean gain from baseline BCVA of 12.7 letters, and patients who received 0.5 mg of Lucentis had a mean gain of 14.9 letters (compared to 0.8 letters for patients receiving sham injections).
“RVO can lead to sudden loss of vision for which there are few treatment options,” points out Hal Barron, M.D., evp, global development and CMO, Genentech. “As early as seven days after their first injection, patients who received monthly injections of Lucentis had, on average, a statistically significant improvement in their vision that lasted through six months.”