Roche recalls new eye therapy Susvimo on leakage fears, aims for market return 'within a year or so'

Just as doctors were starting to cozy up to Roche and Genentech’s new eye drug delivery therapy, the companies are pulling the product from U.S. shelves.

Roche has launched a voluntary recall of Susvimo—an implant approved for wet age-related macular degeneration (AMD) that dispenses a special formulation of ranibizumab—thanks to manufacturing problems with the device. The problem relates to the septum, or the seal on the port delivery device that keeps medicine from leaking out once it’s been injected, Roche Pharmaceuticals CEO Bill Anderson explained on a Tuesday investor call.

“[T]hat seal could fail after repeat dosing,” he said.

“And so we decided, because it didn't meet our performance standards, and [because] we want to make sure that we have high reliability, we decided to voluntarily stop distribution of the port delivery system,” he added.

While new patients looking to switch to Roche’s option—which boasts less frequent dosing versus Regeneron rival Eylea and even Roche and Genentech’s own Vabysmo—are out of luck for the time being, patients who already have Susvimo will “continue to receive their refills,” Anderson said.

In the meantime, Roche and Genentech “want to make some corrections to the manufacturing process that we hope can assure greater reliability,” the Roche pharmaceutical chief said.

Roche hopes to put Susvimo back on the market “as soon as possible," he added. In terms of a more concrete timeline, it may take several months to sort out the production glitch, which could allow Roche and Genentech to return with their device to market "within a year or so."

The companies are already in the process of conducting the Susvimo pull with the FDA, Genentech said in an emailed statement. The pause on new implantations extends to ongoing global clinical trials, too, the company added.

The company uncovered the defect while testing its commercial supply by repeatedly puncturing Susvimo implants with a needle. Certain devices failed to “perform to our standards,” Genentech said.

There is no medical need to remove the implant if patients already have it. The recall does not extend to the ranibizumab vial or refill needle, Genentech said.

Roche and Genentech have been angling to accentuate Susvimo’s convenience edge over its AMD opponents. Patients can undergo surgery to get the Susvimo implant installed and refilled with Lucentis just twice a year, versus six to 12 injections for Eylea or three to 12 injections of Vabysmo.

Susvimo had been gaining traction with eye doctors, to be sure, but it still faces an intense fight against Regeneron and Bayer’s entrenched blockbuster Eylea. While “the large majority” of 76 ophthalmologists polled acknowledged Susvimo’s “superior duration of response” when compared to Eylea, respondents “overwhelmingly rate Eylea as safer overall and more accessible," according to a recent report from Spherix analysts.

Editor's note: This story was updated with comments from Genentech.