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Faricimab (Vabysmo®), a novel pharmaceutical agent is a promising treatment for age-related macular degeneration and diabetic macular edema due to its dual mechanism of action, targeting both the VEGF and angiopoietin-2 (Ang-2) pathways, offering potential benefits in improving visual outcomes and reducing treatment burdens. The phase 3 TENAYA and LUCERNE clinical trials have demonstrated its efficacy and safety profile, leading to regulatory approval and increasing use in clinical practice. However, as with any new therapeutic agent, there is a critical need to monitor and evaluate real-world safety data to complement and validate clinical trial findings.
Intraocular inflammation (IOI), which is a significant adverse effect of intravitreal anti-VEGF injections, is of particular interest as it can vary from a mild transient reaction to a potentially vision-threatening outcome.
The incidence and severity of IOI in a real-world settings can vary from clinical trial results due to differences in patient populations, injection techniques, and clinical settings.
The aim of this study is to estimate the real-life incidence of intraocular inflammation following intravitreal faricimab injections at a large, regional highly specialized tertiary center.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Faricimab Injection [Vabysmo] | Drug | The procedures followed local standard protocol, that included the use of 2-3 drops of topical tetracaine anesthesia, use of an eye speculum, topical 5% povidone-iodine disinfection, 33G-needle, injection site 3.5 mm posterior from the limbus marked by calipers in the supertemporal or the inferotemporal quadrant, sterile cotton tip tamponade at the site of injection after removal of the needle, and no post-procedure antibiotics. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of intraocular inflammation (IOI) | Incidence of IOI following the faricimab injection procedure, described as cases per eye, cases per patient and cases per injection | 01/NOV/2023 - 31/AUG/2024 |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in age | Between individuals developing and not developing IOI following faricimab injection | 01/NOV/2023 - 31/AUG/2024 |
| Differences in sex | Between individuals developing and not developing IOI following faricimab injection |
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Inclusion criteria
Exclusion criteria for IOI cases
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Patients in the Capital Region of Denmark who are receiving faricimab injections at our center.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, Rigshospitalet | Glostrup Municipality | 2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16196117 | Background | Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005 Sep;140(3):509-16. doi: 10.1016/j.ajo.2005.03.057. | |
| 33962696 | Background |
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| ID | Term |
|---|---|
| D014605 | Uveitis |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C000723200 | faricimab |
| D058449 | Intravitreal Injections |
| ID | Term |
|---|---|
| D056965 | Injections, Intraocular |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
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| 01/NOV/2023 - 31/AUG/2024 |
| Differences in number of anti-VEGF injections | Between individuals developing and not developing IOI following faricimab injection | 01/NOV/2023 - 31/AUG/2024 |
| Differences between treatment-naïve and switch-patients | Differences in developing and not developing IOI following faricimab injection between patients that received previous anti-VEGF treatments before faricimab and those that did not. | 01/NOV/2023 - 31/AUG/2024 |
| Time from injection to onset of IOI | Measured in days | 01/NOV/2023 - 31/AUG/2024 |
| Disease duration of IOI | Measured in days | 01/NOV/2023 - 31/AUG/2024 |
| Functional outcome of IOI cases | Best-corrected visual acuity (BCVA) before, at, and after onset of the IOI. Measured in Snellen acuity, converted to logMAR. | 01/NOV/2023 - 31/AUG/2024 |
| Anderson WJ, da Cruz NFS, Lima LH, Emerson GG, Rodrigues EB, Melo GB. Mechanisms of sterile inflammation after intravitreal injection of antiangiogenic drugs: a narrative review. Int J Retina Vitreous. 2021 May 7;7(1):37. doi: 10.1186/s40942-021-00307-7. |
| 25822254 | Background | Fine HF, Despotidis GD, Prenner JL. Ocular inflammation associated with antivascular endothelial growth factor treatment. Curr Opin Ophthalmol. 2015 May;26(3):184-7. doi: 10.1097/ICU.0000000000000154. |
| 35474059 | Background | Shirley M. Faricimab: First Approval. Drugs. 2022 May;82(7):825-830. doi: 10.1007/s40265-022-01713-3. |
| Background | European Medicines Agency (2022) Vabysmo. https://www.ema.europa.eu/en/medicines/human/EPAR/vabysmo Accessed: 07 Sep 2023 |
| 35085502 | Background | Heier JS, Khanani AM, Quezada Ruiz C, Basu K, Ferrone PJ, Brittain C, Figueroa MS, Lin H, Holz FG, Patel V, Lai TYY, Silverman D, Regillo C, Swaminathan B, Viola F, Cheung CMG, Wong TY; TENAYA and LUCERNE Investigators. 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. Lancet. 2022 Feb 19;399(10326):729-740. doi: 10.1016/S0140-6736(22)00010-1. Epub 2022 Jan 24. |
| 32729897 | Background | Khanani AM, Patel SS, Ferrone PJ, Osborne A, Sahni J, Grzeschik S, Basu K, Ehrlich JS, Haskova Z, Dugel PU. Efficacy of Every Four Monthly and Quarterly Dosing of Faricimab vs Ranibizumab in Neovascular Age-Related Macular Degeneration: The STAIRWAY Phase 2 Randomized Clinical Trial. JAMA Ophthalmol. 2020 Sep 1;138(9):964-972. doi: 10.1001/jamaophthalmol.2020.2699. |
| 42141825 | Derived | Schneider M, Turan L, Arif F, Bjerager J, Klefter ON, Faber C, Subhi Y, Hajari JN. Real-world incidence and clinical characteristics of intraocular inflammation following intravitreal faricimab therapy: A safety study. Acta Ophthalmol. 2026 May 16. doi: 10.1111/aos.70161. Online ahead of print. |
| D013812 |
| Therapeutics |