Roche recently presented post-hoc analysis results of the TENAYA (NCT03823287) and LUCERNE (NCT03823300) trials of Vabysmo (faricimab), a VEGF and Ang2 inhibitor, at the Association for Research in Vision and Ophthalmology (ARVO) conference. The data showcases Vabysmo’s efficacy in wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), as well as the Swiss pharma major’s eagerness to establish the prescription injection as a leading therapy for multiple ophthalmology indications, says GlobalData.
The two year post-hoc analysis results of the pivotal TENAYA and LUCERNE trials revealed Vabysmo’s extended treatment benefits and potential for dosing every 20 weeks in wet age-related macular degeneration (wAMD). Compared to Eylea, nearly 80 per cent of Vabysmo patients achieved dosing intervals of 12 or 16 weeks, with 56 per cent successfully extending to 20 weeks. Patients with less fluid and fewer pigment epithelial detachments were more likely to qualify for extended dosing.
Another paper addressed the use of Eylea (aflibercept 2mg) and Vabysmo in DME patients with and without hard exudates. Those with baseline hard exudates initially showed slower vision improvement and central subfield thickness reduction but caught up by year two. In comparing Eylea and Vabysmo, while no significant differences were seen at 16 weeks, Vabysmo-treated eyes exhibited a roughly 10 per cent greater reduction in hard exudates by year two.
Sara Reci, MSc, Managing Pharma Analyst at GlobalData, commented, “The results of both studies are embellishing additions to the successful start that Roche’s Vabysmo has had to 2024. In addition to Roche’s robust 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 H2 2024.”
The 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.”
“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 space,” concluded Reci.
Edits Made by EP News Bureau