Image: Atomwise CEO and co-founder Abraham Heifets
A game of two halves for Roche’s recently approved wet AMD assets
Roche has received US FDA approval of two wAMD therapies, but one was recently recalled due to a manufacturing defect, write GlobalData analysts.
Dr Judith M. Sills. Credit: Arriello
Dr Eric Caugant. Credit: Arriello
Of late, it seemed that all the stars had aligned well for Roche in the wet age-related macular degeneration (wAMD) space. With Susvimo (ranibizumab sustained release) winning US FDA approval last year, followed by an FDA approval for Vabysmo (faricimab) this year, Roche had all the right assets to take the game to the current market leader, Regeneron and Bayer’s Eylea (aflibercept), at an accelerated pace. However, that pace is likely to slow down after Susvimo was voluntarily recalled due to a manufacturing defect; the recall was announced on 18 October during an investor call.
Susvimo’s recall is due to a problem related to the seal on the port delivery device, which keeps the medicine from leaking out once it has been injected. Susvimo is an implant that is inserted into the eye to enable continuous release of ranibizumab, and refilled every 24 weeks. The frequency of administration associated with Susvimo represents a significant advancement over other anti-vascular endothelial growth factor (VEGF) therapies that are more commonly used. The latter set of therapies need to be administered on a more-frequent basis, most of them every eight weeks on average, leading to a significant treatment burden.
The need for therapies that can help to prolong treatment intervals for patients with wAMD is an area that pharmaceutical companies continue to focus on for this indication. In that sense, Susvimo represents a significant advancement compared to current standards of care. However, there are a number of caveats associated with this therapy. For one, the need to insert this implant via a surgical route represents a resource-intensive procedure and is likely to limit its wider adoption in the market. In addition, the Susvimo implant is associated with a higher rate of endophthalmitis compared to monthly injections of Lucentis (ranibizumab). These are factors that will be taken into consideration before a patient and physician decide on whether to opt for this therapy, and are likely to be further exacerbated with the latest recall. However, there is no taking away the fact that Susvimo will be of significant value, especially to a select population that requires regular treatment and has demonstrated a good response to anti-VEGF therapy.
Vabysmo, on the other hand, represents a more accessible therapy for patients with wAMD and presents Roche with a therapy that has the potential to compete directly against Eylea. Vabysmo is administered every four weeks for the first four doses, and this frequency may be reduced to as little as twice a year thereafter, depending on results of optical coherence tomography and visual acuity evaluations. That is a significant improvement over the current formulation of Eylea, which needs to be administered every eight to ten weeks, on average. However, Regeneron reported last month that results from a pivotal clinical trial evaluating high-dose Eylea in wAMD patients demonstrated that 77% of patients were maintained on 16-week dosing intervals. While the longer-acting therapies score a definite win for patients and physicians, it is also anticipated that the competition between Roche and Regeneron to win patient shares for this indication with newer formulations will be fierce and one to watch.