Roche receives EU CE mark for its Port Delivery Platform containing Susvimo

Roche (RHHBY) announced that it has received the EU CE mark for its Port Delivery Platform containing Susvimo, which will now be known as Contivue in the EU. The device comprises the eye implant through which Susvimo is delivered, and four ancillary devices to initially fill, insert, refill, and remove the implant. Susvimo 100 mg/mL is currently under review with the European Medicines Agency, EMA, for the treatment of nAMD. New long-term data from the LADDER study, presented at the 25th EURETINA Congress in Paris, France, shows that Contivue with Susvimo provides good visual outcomes with stable retinal anatomy over the longer term. In the 59 patients continuously treated with Contivue with Susvimo over seven years, best-corrected visual acuity was 70.4 letters at baseline and 63.2 letters at seven years, an average decline of only six letters approximately over that time for patients who were at or near peak levels at the time of enrolment after receiving three intravitreal injections of standard of care. Half of all patients had approximately 20/40 vision at seven years. Contivue with Susvimo durability was maintained in approximately 95% of patients.