Genentech voluntarily recalls Susvimo ocular implant

Arshad Khanani, MD, MA, FASRS

The Susvimo implant was FDA approved in October 2021 for the treatment of wet AMD. Susvimo is the first sustained released device approved to treat wet AMD and this was based on the positive data from the phase 3 ARCHWAY study.

Genentech has announced they are voluntarily recalling all commercial Susvimo implants based on recent testing of commercial supply in which Susvimo implants were exposed to repeated puncturing with a refill needle. The results showed that some implants did not perform to meet the standards. All Susvimo implantations have been paused in clinical studies as well as in the commercial setting.

The Port Delivery System (PDS) program has been through major hurdles even prior to the approval, and the surgical technique continued to evolve post approval. In the phase 2 LADDER study, the initial rate of vitreous hemorrhage from the implantation procedure was close to 50% and the program was halted. After the introduction of laser to the pars plana, the rate was reduced to 5%. In addition, the adverse events profile for PDS in the phase 2 and phase 3 trials include cases of conjunctival erosions, conjunctival retractions and endophthalmitis. There is also a box warning for Susvimo due to the 2% risk of endophthalmitis, which was 3-fold higher in patients with PDS compared to the intravitreal injection cohort in the clinical trials. Eight out of 11 cases of endophthalmitis in the clinical trials were associated with conjunctival erosions and retractions. Due to this, the focus post approval has been on surgical technique and following instructions for use in an attempt to lower this rate. But now, septum dislodgement has been seen in 2% to 3% of patients with PDS in clinical trials. Initially, this was partially attributed to the trauma from the refill exchange technique due to twisting, but more investigations were done to evaluate implant integrity and not all implants are meeting the standards set by Genentech.

In my opinion, a voluntary recall shows a commitment from Genentech to put patients’ safety and well-being first. This also shows Genentech’s commitment to product quality. A surgical device that can control disease as well as monthly intravitreal injections is now taken off the market to make it better for patients in the future. This is not an easy decision for any company, but it is the right decision. Optimal patient experience and outcomes must be a priority for any new treatment option for wet AMD, as we have intravitreal injections that have a great track record. The question is, why should we continue to work on this device or other modes of sustained delivery for our patients when we have intravitreal agents that are very safe? There are several reasons. Real world outcomes in patients with wet AMD continue to be poor due to high treatment burden and missed visits. Also, there are many patients in our clinic that have anxiety with injections, and because of this more than 90% of patients in the ARCHWAY study preferred PDS over intravitreal injections. As surgeons, we know that a surgical procedure will never be as safe as an in-clinic intravitreal injection, but the treatment burden and poor real-world outcomes continue to drive us to look for better treatment options even if they are surgical in nature. In my experience, Susvimo was never designed to be a primary treatment option, and it is only for a small subset of patients, but once the patients get Susvimo, they are the happiest patients in my clinic. As physicians, nothing is more important to us than patient safety and well-being. Based on the quality data showing that some implants did not perform to meet the standards set by Genentech, recalling Susvimo is the right thing to do. This is clearly a setback for our field, but innovation is never easy and always comes with challenges. I hope that the resolution to this product quality issue can be achieved in a timely fashion, so Susvimo can be again available for a subset of our patients with wet AMD who are at risk of vision loss over time due to undertreatment with intravitreal injections. In the meantime, it’s our duty to cater to all patients with Susvimo implants in their eyes by carefully performing the refill-exchange procedure as needed and to look out for septum dislodgements over time in these patients.

Rishi P. Singh, MD

Retina specialists have struggled with durability of anti-VEGF treatment for exudative macular degeneration. Despite the visual gains seen with anti-VEGF treatment, long-term outcomes and treatment infrequency had led to less than optimal outcomes. The Susvimo implant was an innovative approach at sustained delivery released this year, and recent studies have shown hundred of implants delivered to patients in the U.S. The initial studies led to important findings on correct implantation technique. In addition, based upon the results, there was a warning to consumers of higher than normal rates of endophthalmitis following implantation. Thus, implantation and refills techniques further evolved to minimize this risk.

Genentech has voluntarily recalled the Susvimo implant. As this point, Genentech is not recommending removal of the implants, and patients who have these implants should continue to receive refill procedures.

While the recall is a setback for the retinal community and to innovation, the implant serves as a potential first iteration of sustained delivery. Without studying this opportunity and pushing the limitations of what can be performed and tolerated, we would not have learned about these issues with the implant. Genentech/Roche continues to support the program and has committed itself to finding a path forward for patients to improve and sustain vision following treatment. As information evolves from these patients and studies, we will gain the knowledge that might make this program successful in the future.