Sustained Delivery Technology for Lucentis Performing Well in Early Clinical Trial
While Lucentis® has saved vision in millions
with wet age-related macular degeneration (AMD) since it was approved by the
FDA in 2006, the need for monthly injections of the treatment has been a
significant inconvenience for patients.
However, Genentech, maker of Lucentis, is reporting progress in development of a device aimed at reducing the number of injections. The company’s 20-participant Phase Ia clinical trial of a sustained delivery device, known as a port delivery system (PDS), is showing positive results for safety and the diffusion of Lucentis to affected areas of the retina. Investigators believe that the PDS can provide four months of therapy before needing to be refilled.
Initially, the PDS, a small capsule-like container, is implanted in the eye above the iris through what the investigators call “a standard 15-minute retinal surgery technique.” The device is then easily refilled by injection in the doctor’s office with high-concentration Lucentis.
Genenetch is licensing the PDS technology from ForSight Vision4, a commercial developer of ophthalmological treatment technologies. Genentech plans to formally announce the Phase Ia results soon, and hopes to launch a Phase Ib trial before the end of 2012.
AMD is the leading cause of blindness in people 50 years of age and older in the United States. It affects more than 10 million Americans with the wet form of AMD, causing severe and sudden vision loss.
Lucentis works by clearing up and inhibiting the proliferation of leaky, vision-robbing blood vessels that grow underneath the retina in people with wet AMD.