Genentech receives FDA approval to relaunch Susvimo

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Genentech, a member of the Roche group, has received FDA approval to relaunch Susvimo (ranibizumab injection 100 mg/mL) for intravitreal use via an ocular implant for treating people with wet (or neovascular) age-related macular degeneration (AMD).

Susvimo is a refillable implant approximately the size of a grain of rice, and it sits within the eye, just under the upper eyelid. It continuously releases a specialized formulation of ranibizumab. Susvimo provides continuous delivery of a customized formulation of ranibizumab via the Port Delivery Platform, while other currently approved treatments may require multiple eye injections per year.¹

In October 2022, the company launched a voluntary recall of the implant after it detected an issue with the device. The issue was uncovered when the company tested its commercial supply by puncturing the implants multiple times.

Chris Brittain, senior vice president and global head of ophthalmology product development at Genentech, noted that the septum, the seal on the port delivery device that keeps medicine from leaking out once it has been injected, didn’t perform up to the company’s standards during laboratory testing.

The company received FDA approval for the device in 2021 based on findings from the phase 3 Archway study [NCT03677934[JM1] ] that demonstrated that there was noninferior efficacy with Susvimo twice yearly refills in comparison with monthly ranibizumab injections, which Brittain called “a fantastic result for the device and for patients.”

The voluntary recall was announced approximately a year later.

“Some test results showed that the implants didn’t perform to our standards,” Brittain said. “Since then, we’ve spent the time updating the implant and the refill needle. And based on those updates, we conducted extensive testing again, just to confirm that they meet our performance standards. So that’s why we’re excited to bring it back.”

Moreover, Brittain noted that doing a voluntary recall was the right decision.

“Patient safety is fundamental to us,” he explained. “So if any technology, be it a therapeutic or a device, doesn’t meet our standards, we make a very patient-focused decision. And this was absolutely the right thing, and it was something that we didn’t question.”

After nearly 2 years of additional research, Brittain said the company has met its performance standards with the modifications and is looking forward to the relaunch.

Brittain explained that the septum was dislodging into the reservoir, which could prevent the device from working properly.

“After we saw a number of these cases occurring in the clinical trial setting, we decided that it was not meeting the performance specifications,” he said. “We redeveloped and modified both the device and the refill needle.”

Test results on the revised version showed the septum issue was corrected and the device was performing up to the company’s standard.

As part of the revisions, the company made changes to an interface between the septum, the element that was dislocating, and the overmold, which is the top of the device. Brittain noted that the company has doubled the bond strength. Lubrication has been added to the refill needle, reducing the insertion force needed by more than 50%.

“It is those 2 changes in combination that have enabled us to meet these performance specifications,” Brittain said.

Brittain noted a lot of work has gone into the revisions, and testing has been conducted on the modified device and refill needle.

The relaunch of the device is also welcome news to retina specialists and the patients they treat who have been diagnosed with wet AMD.

Brittain explained the current standard of care is intravitreal injections, with many having a frequency of every month and newer options offering a frequency of every 4 months.

“Susvimo allows you to have confidence to go up to 6 months between refills, so that really addresses a major unmet need, which is the treatment burden while maintaining efficacy as we’ve seen in the Archway study [findings] noninferior to monthly injections,” he said. “[Findings from] the Archway study showed patient preference for the implant.”

In the wake of the relaunch of the implant device, Genentech’s therapeutic approach may also be laying the groundwork for future advancements, according to Brittain.

“You can put other molecules and other therapeutics into the device, and we already have one in clinic at the moment, which is in an ongoing phase 1 study. And, the potential there is to continue to further expand or prolong the intervals between retreatments,” he said.

The device could also lead to options for treating other retinal conditions, including diabetic macular edema, diabetic retinopathy, and geographic atrophy.

With the relaunch, Genentech is confident it can meet demand for Susvimo.

“It is going to be an important treatment option,” Brittain concluded. “We are confident we will be able to meet the demand.”

David Almeida, MD, a retina specialist and founder of Erie Retina Research, said the announcement is good news for retina specialists and the patients they treat.

“In my practice, I see many patients who are at risk of losing vision due to wet AMD and face a high burden of treatment,” he said. “I’m excited to offer these patients Susvimo as an effective alternative to regular eye injections to help preserve their vision, without the need for frequent treatments.”

Reference

1. Genentech: Press Releases | Monday, Jul 8, 2024. www.gene.com. Accessed July 8, 2024. https://www.gene.com/media/press-releases/15031/2024-07-08/genentech-to-reintroduce-susvimo-for-peo