Review of real-world evidence of dual inhibition of VEGF-A and ANG-2 with faricimab in NAMD and DME
Abstract Management of vitreoretinal disorders (e.g., neovascular age-related macular degeneration [nAMD] and diabetic macular edema [DME]) have assumed the standard therapy of lifelong anti-VEGF injections with drugs like aflibercept, brolucizumab, ranibizumab and bevacizumab. However, the burden i...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMC
2024-01-01
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| Series: | International Journal of Retina and Vitreous |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s40942-024-00525-9 |
| _version_ | 1827377206839476224 |
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| author | Fernando M Penha Maliha Masud Zoha A. Khanani Mathew Thomas Rodney D. Fong Kyler Smith Avishay Chand Majid Khan Greggory Gahn Gustavo Barreto Melo Arshad M. Khanani |
| author_facet | Fernando M Penha Maliha Masud Zoha A. Khanani Mathew Thomas Rodney D. Fong Kyler Smith Avishay Chand Majid Khan Greggory Gahn Gustavo Barreto Melo Arshad M. Khanani |
| author_sort | Fernando M Penha |
| collection | DOAJ |
| description | Abstract Management of vitreoretinal disorders (e.g., neovascular age-related macular degeneration [nAMD] and diabetic macular edema [DME]) have assumed the standard therapy of lifelong anti-VEGF injections with drugs like aflibercept, brolucizumab, ranibizumab and bevacizumab. However, the burden imposed on patients is a major deterrent for continual therapy and recovery. Faricimab, a bispecific antibody, blocking both VEGF-A and Ang-2 molecules, produces a comparable functional and anatomical results, with less injections, significantly reducing patient burden. Visual acuity, safety, adverse effects, and anatomical outcomes are discussed in the pivotal clinical trials (YOSEMITE/RHINE and TENAYA/LUCERNE), and early data from real-world studies (TRUCKEE, TAHOE, FARWIDE-DME, FARETINA and others). In YOSEMITE and RHINE, faricimab demonstrated non-inferior vision gains, better anatomical outcomes compared to aflibercept every 8 weeks. Faricimab in the personalized treatment interval (PTI), after week 96, achieved 12-week interval in 78.1% of the patients and 16-week interval in 62.3%. TENAYA and LUCERNE reported comparable best corrected visual acuity (BCVA) improvement and better anatomic outcomes during head-to-head phase, parallel to aflibercept, at its 8-week treatment schedule. Faricimab in the PTI regimen, after week 96 achieved 12-week interval in 77.8% of the patients and 16-week interval in 63.1%. Safety of faricimab has been comparable to aflibercept in these pivotal trials. Real-world data supports the data from the pivotal studies regarding the efficacy and safety profile of faricimab in heterogenous real world patient population. Moreover, in previously treated patients, it also demonstrated a faster fluid resolution, good safety profile. Considering faricimab has demonstrated anatomic and durability benefit in the treatment of nAMD and DME, additional data from ongoing extension clinical trials, AVONELLE-X and RHONE-X will help understand longer term outcomes for patients treated with faricimab as well as patients switching from aflibercept to faricimab after finishing the pivotal trials. Longer term data from the real-world studies will also continue to contribute to our understanding of long-term efficacy, safety and durability in the real world patient population. |
| first_indexed | 2024-03-08T12:35:39Z |
| format | Article |
| id | doaj.art-ae11d4baec3d46d4b4a667d73a6f4d9c |
| institution | Directory Open Access Journal |
| issn | 2056-9920 |
| language | English |
| last_indexed | 2024-03-08T12:35:39Z |
| publishDate | 2024-01-01 |
| publisher | BMC |
| record_format | Article |
| series | International Journal of Retina and Vitreous |
| spelling | doaj.art-ae11d4baec3d46d4b4a667d73a6f4d9c2024-01-21T12:29:44ZengBMCInternational Journal of Retina and Vitreous2056-99202024-01-011011910.1186/s40942-024-00525-9Review of real-world evidence of dual inhibition of VEGF-A and ANG-2 with faricimab in NAMD and DMEFernando M Penha0Maliha Masud1Zoha A. Khanani2Mathew Thomas3Rodney D. Fong4Kyler Smith5Avishay Chand6Majid Khan7Greggory Gahn8Gustavo Barreto Melo9Arshad M. Khanani10Fundação Universidade Regional de Blumenau, FURBUniversity of Nevada, Reno School of MedicineUniversity of Nevada, Reno School of MedicineUniversity of Nevada, Reno School of MedicineUniversity of Nevada, Reno School of MedicineUniversity of Nevada, Reno School of MedicineUniversity of Nevada, Reno School of MedicineUniversity of Nevada, Reno School of MedicineUniversity of Nevada, Reno School of MedicineFederal University of São Paulo, UNIFESPUniversity of Nevada, Reno School of MedicineAbstract Management of vitreoretinal disorders (e.g., neovascular age-related macular degeneration [nAMD] and diabetic macular edema [DME]) have assumed the standard therapy of lifelong anti-VEGF injections with drugs like aflibercept, brolucizumab, ranibizumab and bevacizumab. However, the burden imposed on patients is a major deterrent for continual therapy and recovery. Faricimab, a bispecific antibody, blocking both VEGF-A and Ang-2 molecules, produces a comparable functional and anatomical results, with less injections, significantly reducing patient burden. Visual acuity, safety, adverse effects, and anatomical outcomes are discussed in the pivotal clinical trials (YOSEMITE/RHINE and TENAYA/LUCERNE), and early data from real-world studies (TRUCKEE, TAHOE, FARWIDE-DME, FARETINA and others). In YOSEMITE and RHINE, faricimab demonstrated non-inferior vision gains, better anatomical outcomes compared to aflibercept every 8 weeks. Faricimab in the personalized treatment interval (PTI), after week 96, achieved 12-week interval in 78.1% of the patients and 16-week interval in 62.3%. TENAYA and LUCERNE reported comparable best corrected visual acuity (BCVA) improvement and better anatomic outcomes during head-to-head phase, parallel to aflibercept, at its 8-week treatment schedule. Faricimab in the PTI regimen, after week 96 achieved 12-week interval in 77.8% of the patients and 16-week interval in 63.1%. Safety of faricimab has been comparable to aflibercept in these pivotal trials. Real-world data supports the data from the pivotal studies regarding the efficacy and safety profile of faricimab in heterogenous real world patient population. Moreover, in previously treated patients, it also demonstrated a faster fluid resolution, good safety profile. Considering faricimab has demonstrated anatomic and durability benefit in the treatment of nAMD and DME, additional data from ongoing extension clinical trials, AVONELLE-X and RHONE-X will help understand longer term outcomes for patients treated with faricimab as well as patients switching from aflibercept to faricimab after finishing the pivotal trials. Longer term data from the real-world studies will also continue to contribute to our understanding of long-term efficacy, safety and durability in the real world patient population.https://doi.org/10.1186/s40942-024-00525-9Anti-VEGF-AAngiopoietin 2Neovascular age-related macular degenerationDiabetic macular edemaFaricimabAflibercept |
| spellingShingle | Fernando M Penha Maliha Masud Zoha A. Khanani Mathew Thomas Rodney D. Fong Kyler Smith Avishay Chand Majid Khan Greggory Gahn Gustavo Barreto Melo Arshad M. Khanani Review of real-world evidence of dual inhibition of VEGF-A and ANG-2 with faricimab in NAMD and DME International Journal of Retina and Vitreous Anti-VEGF-A Angiopoietin 2 Neovascular age-related macular degeneration Diabetic macular edema Faricimab Aflibercept |
| title | Review of real-world evidence of dual inhibition of VEGF-A and ANG-2 with faricimab in NAMD and DME |
| title_full | Review of real-world evidence of dual inhibition of VEGF-A and ANG-2 with faricimab in NAMD and DME |
| title_fullStr | Review of real-world evidence of dual inhibition of VEGF-A and ANG-2 with faricimab in NAMD and DME |
| title_full_unstemmed | Review of real-world evidence of dual inhibition of VEGF-A and ANG-2 with faricimab in NAMD and DME |
| title_short | Review of real-world evidence of dual inhibition of VEGF-A and ANG-2 with faricimab in NAMD and DME |
| title_sort | review of real world evidence of dual inhibition of vegf a and ang 2 with faricimab in namd and dme |
| topic | Anti-VEGF-A Angiopoietin 2 Neovascular age-related macular degeneration Diabetic macular edema Faricimab Aflibercept |
| url | https://doi.org/10.1186/s40942-024-00525-9 |
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