- In the TENAYA and LUCERNE studies, more than 60% of Vabysmo patients could be treated every four months at two years. This represents an increase from 45% at year one
- Patients treated with Vabysmo received a median number of 10 injections over the two years versus 15 injections for those treated with aflibercept, potentially decreasing the number of injections
- No new safety signals were identified and Vabysmo continued to be well tolerated, with a favourable benefit-risk profile
“These longer-term results reinforce confidence in Vabysmo and support its continued use in people with neovascular AMD,” said
In the TENAYA and LUCERNE studies, at two years:1
- More than 60% 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% 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.
The primary analyses at one year formed the basis of the recent nAMD approvals in the US,
Vabysmo is the first bispecific antibody for the eye and the only injectable eye medicine approved in a number of countries for treatments up to four months apart. 4,5 Vabysmo is designed to block two disease pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). 4 While research is underway to better understand the role of the Ang-2 pathway in retinal disease, Ang-2 and VEGF-A are thought to contribute to vision loss by destabilising blood vessels, which may cause new leaky blood vessels to form and increase inflammation. 4
Detailed Two-Year Results 1
In the TENAYA and LUCERNE studies, nAMD patients received Vabysmo given at intervals of two, three or four months or aflibercept given every two months. In the second year, the dosing schedule for Vabysmo patients could be adjusted based on their response to treatment.
At two years, vision improvements were comparable across both treatment arms. In TENAYA, the average vision gains from baseline at two years were +3.7 eye chart letters in the Vabysmo arm and +3.3 letters in the aflibercept arm. In LUCERNE, the average vision gains from baseline at two years were +5.0 letters in the Vabysmo arm and +5.2 letters in the aflibercept arm.
Furthermore, 59% (n=160/271) of Vabysmo patients in TENAYA and 67% (n=192/287) in LUCERNE achieved four-month dosing at two years. This is an increase over one-year results, which showed 46% (n=144/315) of Vabysmo patients in TENAYA and 45% (n=142/316) in LUCERNE achieved four-month dosing. An additional 15% (n=41/271) of Vabysmo patients in TENAYA and 14% (n=41/287) in LUCERNE achieved three-month dosing at two years. Combined, more than 78% of Vabysmo patients were able to go three months or longer between treatments at the end of the second year.
In both studies, comparable reductions in CST were observed with Vabysmo given at intervals of up to four months versus aflibercept given every two months. Safety results were consistent across study arms, with no reported cases of retinal vasculitis or intraocular inflammation (IOI) associated with retinal vein or retinal artery occlusion.
About the TENAYA and LUCERNE studies 1
TENAYA (NCT03823287) and LUCERNE (NCT03823300) are two identical, randomised, multicentre, double-masked, global phase III studies evaluating the efficacy and safety of Vabysmo compared to aflibercept in 1,329 people living with nAMD (671 in TENAYA and 658 in LUCERNE). The studies each have two treatment arms: Vabysmo 6 mg administered at intervals of two, three, or four months, following four initial monthly doses, selected based on objective assessment of disease activity as measured by optical coherence tomography and visual acuity evaluations at weeks 20 and 24; and aflibercept 2 mg administered at fixed two-month intervals after three initial monthly doses. At week 60, patients randomised to the Vabysmo arm were treated using a treat-and-extend approach up to week 108. Dosing schedule for Vabysmo patients during the treat-and-extend phase was adjusted based on treatment response as determined by central subfield thickness (CST) and visual acuity. In both arms, sham injections were administered at study visits when treatment injections were not scheduled to maintain the masking of investigators and participants.
The primary endpoint of the studies is the average change in best-corrected visual acuity (BCVA) score (the best distance vision a person can achieve – including with correction such as glasses – when reading letters on an eye chart) from baseline, averaged over weeks 40, 44 and 48. Secondary endpoints include safety; the percentage of participants in the Vabysmo arm receiving treatment every two, three and four months; the percentage of participants achieving a gain, and the percentage avoiding a loss, of 15 letters or more in BCVA from baseline over time; and change in CST from baseline over time.
About neovascular age-related macular degeneration
Age-related macular degeneration (
About Vabysmo® (faricimab) 4
Vabysmo is the first bispecific antibody approved for the eye. It targets and inhibits two disease pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by destabilising blood vessels, causing new leaky blood vessels to form and increasing inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilise blood vessels.
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Applying our extensive experience, we have already brought breakthrough ophthalmic treatments to people living with vision loss. Susvimo™ (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant is the first
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References
[1] Khanani A, et al. Faricimab in Neovascular Age-Related Macular Degeneration: Year 2 Efficacy, Safety, and Durability Results From the Phase 3 TENAYA and LUCERNE Trials. Presented at: 2022 American Society of Retina Specialists Annual
[2]
[3] Connolly E, et al. Prevalence of age-related macular degeneration associated genetic risk factors and 4-year progression data in the Irish population. Br
[4] Heier, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials.
[5] FDA. Highlights of prescribing information, Vabysmo. 2022.
[6] Clinical Trials.gov. A study to evaluate the long-term safety and tolerability of faricimab (RO686746) in participants with neovascular age-related macular degeneration (AVONELLE-X). [Internet; cited
[7] Clinical Trials.gov. A study to evaluate the long-term safety and tolerability of faricimab (RO686746) in participants with diabetic macular edema (Rhone-X). [Internet; cited
[8] Clinical Trials.gov. A study to evaluate the efficacy and safety of faricimab in participants with macular edema secondary to central retinal or hemiretinal vein occlusion (COMINO). [Internet; cited
[9] Clinical Trials.gov. A study to evaluate the efficacy and safety of faricimab (RO6867461) in participants with macular edema secondary to branch retinal vein occlusion (BALATON). [Internet; cited
[10] Clinical Trials.gov. A study to investigate faricimab treatment response in treatment-naïve, underrepresented patients with diabetic macular edema (ELAVATUM). [Internet; cited
[11] All About Vision. Macula Lutea. [Internet; cited
[12] Pennington KL, et al. Epidemiology of age-related macular degeneration (
[13] Little K, et al. Myofibroblasts in macular fibrosis secondary to neovascular age-related macular degeneration-the potential sources and molecular cues for their recruitment and activation. EBioMedicine. 2018;38:283-91.
[14] Wong WL, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis.
[15] FDA. Highlights of prescribing information, Susvimo. 2021.
[16] FDA. Highlights of prescribing information, Lucentis. 2006.
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