At the Association for Research in Vision and Ophthalmology (ARVO) conference in Seattle, WA, US, discussions included the coverage of two studies that showed the potential of Roche’s Vabysmo (faricimab), a vascular endothelial growth factor inhibitor and angiopoietin 2 inhibitor therapy.
Vabysmo gained US Food and Drug Administration (FDA) approval in January 2022 in the wet age-related macular degeneration (wAMD) and diabetic macular oedema (DME) spaces. Data from the studies showcased Vabysmo’s potential to extend treatment outcomes, reduce dosing to every 20 weeks in patients with wAMD, and reduce the proportion of hard exudates in patients with DME.
In a post-hoc analysis of the pivotal TENAYA (NCT03823287) and LUCERNE (NCT03823300) trials, results presented by Philip P Storey MD demonstrated Vabysmo’s extended treatment outcomes, as well as its potential for reducing dosing to every 20 weeks. This two-year study compared Vabysmo to Eylea (aflibercept) (dosing every eight weeks) in wAMD patients, and revealed that almost 80% of Vabysmo patients achieved 12 weekly or 16 weekly dosing intervals. Additionally, the study determined that 56% of patients who were dosed every 16 weeks could be extended to dosing every 20 weeks using the same criteria, while 44% did not qualify for this extension due to anatomical changes such as an increase in central subfield thickness.
The results also revealed that patients with less fluid and lower pigment epithelial detachments were more likely to be extended. Although the study lacked an arm with dosing every 20 weeks, data suggests that this dosing schedule could have been successful for over half of the patients, showcasing Vabysmo’s potential.
Another paper addressed the use of Eylea (aflibercept 2mg) and Vabysmo in DME patients with and without hard exudates. The results, which were presented by Roger Goldberg MD showed that patients with hard exudates at baseline showed slower vision improvement and reduction in central subfield thickness compared to patients who did not have hard exudates at baseline over 16 weeks, one year and two years, but eventually caught up to the patient group with no hard exudates by year two. Furthermore, when comparing Eylea and Vabysmo in patients with hard exudates, while results at 16 weeks showed no significant difference between patients treated with Eylea or Vabysmo, eyes treated with Vabysmo demonstrated around a 10% greater reduction in hard exudates by year two compared to eyes treated with Eylea.
Key opinion leaders (KOLs) interviewed by GlobalData noted that one obstacle in the management of wAMD is the frequency of injections, with one KOL stating that “some people require regular and frequent dosing…if we have somebody who is requiring four or six weekly injections with aflibercept, that's an indication for us to switch to faricimab and see if we get longer treatment intervals. We seem to get better response with faricimab. So, it may well be, you know, that we broaden our threshold for that, so make it up to eight weeks and see if we get longer. You could make a case for doing faricimab…and this might also be that we make a case for doing faricimab as a first-line agent so we don't have to do the switching.”
The results of both papers presented at ARVO are embellishing additions to the successful start that Roche’s Vabysmo has had to 2024. In addition to Roche’s robust first quarter (Q1) sales figures, the company is implementing strategic measures to strengthen its presence in the wAMD, DME and diabetic retinopathy (DR) markets. Roche plans to re-launch Susvimo for wAMD in Q3 following a voluntary recall due to leakage issues, and to submit regulatory filings for DME and DR as new indications for Susvimo in the first half (H2) of 2024. If Vabysmo continues to deliver strong sales performance and positive trial outcomes, in addition to the anticipated re-launch and label expansion of Susvimo, Roche will be poised to establish itself as a leader in the ophthalmology sector.
