Genentech’s Port Delivery System for Wet AMD Meets Primary Endpoint in Phase 3 Clinical Trial

Though several treatments are approved by the US Food & Drug Administration (FDA) for the treatment of wet age-related macular degeneration (AMD), they require regular visits to the eye doctor’s office for injections into the vitreous, the soft gel in the middle of the eye. The wet AMD treatments, known as anti-VEGFs (blocking vascular endothelial growth factor), are designed to inhibit the growth of leaky blood vessels, which cause loss of photoreceptors, the retinal cells that make vision possible.

Genentech’s Port Delivery System (PDS), a permanent, refillable implant the size of a rice grain, is being developed to provide continual delivery of an anti-VEGF treatment to the retina. In a Phase 3 clinical trial, a single PDS implant performed as effectively as six monthly injections of Lucentis® (an FDA-approved anti-VEGF therapy). The PDS continually delivered a customized formulation of Lucentis for six months without being refilled. The primary outcome measure for the Phase 3 clinical trial was change in best-corrected visual acuity (measured by reading letters on an eye chart).

Genentech plans to submit full results for the PDS trial to health authorities around the world, including the FDA and European Medicines Agency, for consideration of regulatory approval for the treatment of  wet AMD.

“The Port Delivery System is showing great promise for significantly reducing the number of visits to the eye doctor’s office and the number of injections into the eyes for people with wet AMD, who are typically senior citizens,” says Brian Mansfield, PhD, executive vice president for research and interim chief scientific officer at the Foundation Fighting Blindness. “Furthermore, refilling the Port Delivery System is less invasive than the current therapeutic injections of anti-VEGFs directly into the eye.”