Susvimo: Withdrawal of the marketing authorisation application

Susvimo was developed as a medicine to treat adults with the ‘wet’ form of age-related macular degeneration (AMD), a disease that affects the central part of the retina (called the macula) at the back of the eye and causes gradual loss of vision.

Susvimo was intended only for patients who had previously responded to two injections of a so-called VEGF inhibitor into the eye. The active substance in Susvimo, ranibizumab, is a VEGF inhibitor that was to be delivered over time via an eye implant.

Susvimo was to be given via a refillable implant inserted into the eye. This implant was designed to release the medicine into the eye over time and to be refilled every 6 months by a doctor specialised in eye care. 

The active substance in Susvimo, ranibizumab, is a small piece of a monoclonal antibody (a type of protein that has been designed to recognise and attach to a specific target called an antigen). 

Ranibizumab attaches to and block a substance called vascular endothelial growth factor A (VEGF-A). VEGF-A is a protein that makes blood vessels grow and leak fluid and blood, damaging the macula. By blocking VEGF-A, ranibizumab reduces the growth of the blood vessels and controls the leakage and swelling.
 

The company presented results from a main study involving 418 patients with ‘wet’ AMD. The patients in this study were given an implant releasing Susvimo that was refilled every 24 weeks or an injection into the eye with another medicine containing the same active substance every 4 weeks. The study evaluated how well Susvimo worked in improving eyesight compared with the injected medicine.

The application was withdrawn after the European Medicines Agency had evaluated the information from the company and prepared questions. After the Agency had assessed the company’s responses to the last round of questions, there were still some unresolved issues.

At the time of the withdrawal, the Agency had requested more information to show that the implant complied with EU standards. 

In addition, the Agency noted that the proposed use of Susvimo would have to be changed so that the medicine could only be used in patients who had an adequate and stable response to previous injections with a VEGF inhibitor.

Therefore, at the time of the withdrawal, the Agency’s opinion was that Susvimo could not have been approved for the treatment of neovascular ‘wet’ AMD.
 

In its letter notifying the Agency of the withdrawal of the application, the company stated that its withdrawal was based on the status of the conformity review for the implant by the Notified Body and on CHMP’s requirements requesting a declaration of conformity.

The company informed the Agency that there are no consequences for patients in clinical trials using Susvimo.

If you are in a clinical trial and need more information about your treatment, speak with your clinical trial doctor.