Regulatory Latest eye therapy recalled by Roche due to leakage...

Latest eye therapy recalled by Roche due to leakage doubts, target’s return inside a year


Roche and Genentech’s latest eye therapy called Susvimo was charming doctors before the companies decided to pull out the product from the U.S. market.

Susvimo is an implant by the companies which was approved for AMD (wet age-related muscular degeneration) and supplies ranibizumab. The companies recalled the device owing to manufacturing issues associated with it. Bill Anderson, the CEO of Roche Pharma explained during a midweek investor call that the issue is fairly simple and relates to the leakage of the medicine from the seal, or the septum, that is on the device after it has been injected. He claimed that after repeated administration, the seal could break or leak.

He added, “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 also said that patients who are already using the product will keep on receiving the refills, but no good news for the patients as they cannot avail the device for now. Susvimo is better in terms of dosage frequency compared to its competitors Vabysmo, which is Roche and Genentech’s very own, and Regeneron’s Eylea. However, the people who want to shift to Susvimo to reap the advantage can only do so when it is made available again.

To rectify the problem, the companies aim to make some changes in the manufacturing process to ensure that the products coming out of the plant are more reliable. As told by Mr. Anderson, the product’s market return could realistically take around a year as it could take numerous months to figure out and remedy the production bug.

In a statement via email, Genentech revealed that the procedure of pulling Susvimo off the market is underway with the FDA. The company also stated that the new drug insertions are halted till the ongoing clinical trials are concluded. 

The fault was discovered during commercial supply testing where the products were pricked with a needle multiple times. The company claims that some implants did not meet its standards. Genentech also said that the implants already being used by patients need not be removed, and the recall does not include the refill needle or the ranibizumab vial.

Both companies have been trying to highlight the convenience advantage of Susvimo over the AMD competition. The difference is significant as once the implant is injected via surgery, it can be refilled with Lucentis just two times annually compared to between three and twelve times for Vabysmo or between six and twelve times for Eylea.

Even though eye doctors were beginning to lean towards Susvimo, its competition with Regeneron and Bayer’s Eylea remains tough, as it has a strong position in the market. According to a report from analysts from Spherix, a big majority of 76 ophthalmologists recognized Susvimo’s better duration of response in comparison to Eylea, it was also revealed that a vast majority believe Eylea to have greater availability and to be safer in comparison to Roche and Genentech’s Susvimo.

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