Roche, already prepping 2021 launch, charts big expansion plans for Lucentis eye implant

Roche Genentech
Looking beyond wet AMD, Roche has kicked off two phase 3 trials of its Port Delivery System in diabetic macular edema and diabetic retinopathy. (Roche).

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.

RELATED: Novartis, Regeneron wage acrimonious patent fight over Eylea's prefilled syringe

Meanwhile, Roche is enrolling a phase 3 trial of the PDS in diabetic macular edema (DME) patients. Data from that trial is expected in the first half of 2022, Cristin Hubbard, SVP of global product strategy, immunology, infectious diseases and ophthalmology, said at the virtual event. The company has also kicked off a phase 3 in diabetic retinopathy (DR).

Roche's ultimate goal for the PDS extends beyond Lucentis, though. It aims to pair the PDS with its DutaFabs platform—a novel bispecific antibody format that's significantly smaller than traditional bispecifics. Three of those antibodies are already in development, Hubbard said.

RELATED: Roche, wielding new implant data, looks beyond Lucentis for wet AMD

Roche’s PDS could breathe some new life into Lucentis, which has struggled against pandemic headwinds while its Regeneron-made rival Eylea braves the storm. Roche’s ophthalmology business has taken a particularly heavy blow this year amid COVID-19 hospital closures and other disruptions.

Lucentis' U.S. sales dropped 19% in the first half of this year, according to Roche’s midyear 2020 earnings report (PDF). Meanwhile, Eylea brought in $1.11 billion in second-quarter U.S. sales, a 4% decline year-over-year, but still ahead of COVID-tempered expectations.

But though Roche has high hopes for its PDS system, SVB Leerink analyst Geoffrey Porges has his doubts. The higher likelihood of side effects from the PDS compared to traditional eye injections could hinder early adoption, Porges wrote in a recent note to clients.

Porges also cautioned that the PDS-Lucentis pairing may have a hard time chipping away at the hold Eylea has established in the field since its 2019 debut.