Roche yesterday announced new two-year data from the Tenaya and Lucerne studies that reinforce the long-term efficacy, safety and durability of Vabysmo (faricimab) in neovascular or “wet” age-related macular degeneration (nAMD), that affects nearly 20 million people globally and can require treatment with eye injections every one-to-two months. The two-year data were presented at the 2022 American Society of Retina Specialists Annual Scientific Meeting yesterday.
In the Tenaya and Lucerne studies, at two years,
- more than 60 per cent of people receiving Vabysmo could be treated every four months – an increase of over 15 percentage points since the primary analysis at one year – while achieving comparable vision gains versus aflibercept given every two months.
- nearly 80 per cent of people receiving Vabysmo could be treated every three months or longer.
- patients treated with Vabysmo received a median number of 10 injections over the two years versus 15 injections for those patients treated with aflibercept, potentially decreasing the number of injections.
- comparable reductions in central subfield thickness (CST) were observed with Vabysmo given at intervals of up to four months versus aflibercept given every two months.
- no new safety signals were identified and Vabysmo continued to be well-tolerated, with a favourable benefit-risk profile, according to the statement.
Further, the statement said that the primary analyses at one year formed the basis of the recent nAMD approvals in the US, Japan, the UK and several other countries around the world. Vabysmo is also approved in these countries for Diabetic Macular Edema (DME). Vabysmo is currently under review by the European Medicines Agency (EMA) for these conditions, and submissions to other regulatory authorities around the world are ongoing.