Roche is gearing up to launch an eye implant that promises to make its Lucentis macular degeneration treatment easier to use. But the Swiss drugmaker isn't stopping there with the tiny device. It's aiming for new indications for Lucentis therapy—and new pairings with next-gen antibodies, too.
The company aims to file the Port Delivery System (PDS) for FDA approval in wet age-related macular degeneration by year-end and launch in the U.S. next year, Teresa Graham, head of pharma global product strategy at Roche, said during a virtual event Monday. Rollouts beyond the U.S. would follow in 2022, she said.
Developed by Roche's Genentech unit, the PDS is a permanent eye implant about the size of a grain of rice that continuously releases a tweaked version of Lucentis. If it's approved, users would visit their doctors twice a year to refill the device—a far cry from the monthly injections AMD patients currently receive. For the launch, Roche plans to deploy a mix of in-person and digital training tools, plus a remote vision-monitoring app that aims to help patients track changes in sight between treatments.
More than 200 surgeons were trained to install and refill the PDS as part of Roche’s phase 3 trial, Graham said. For new trainees, Roche developed a virtual reality program to help guide doctors through the implant and maintenance process, and a global team of medical liaisons will provide onsite training.
Patients switching from monthly Lucentis injections will be able to download a smartphone app called My Vision Tracker, which provides vision tests and sends alerts straight to doctors if a patient’s sight starts to deteriorate, Graham said.