Faricimab

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Overview

Faricimab (Vabysmo, Genentech, San Francisco, CA) is a combined-mechanism medication with simultaneous and independent binding[1] on both vascular endothelial growth factor A (VEGF-A) and angiopoietin-2 (Ang-2) that is approved for the treatment of diabetic macular edema and neovascular (wet) age-related macular degeneration.

Indications and Use

Faricimab has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of diabetic macular edema and wet age-related macular degeneration.

Mechanism of Action

Faricimab has an inhibitory effect on both VEGF-A and Ang-2 and is thought to have a longer-lasting effect than previous anti-VEGF agents in clinical trials.

Administration and Dosing

Faricimab is given as an intravitreal injection at 6 mg from 0.05 mL of a 120 mg/mL solution.[2] For neovascular age-related macular degeneration, the dose is 6 mg intravitreal every 4 weeks for the first 4 doses, then the same dose either 8 or 12 weeks later depending on findings of optical coherence tomography and visual acuity evaluations. [1]

For diabetic macular edema, faricimab is injected every 4 weeks for the first 4 doses. Afterwards, a personalized treatment interval similar to treat and extend can be implemented. The dosing interval may then be adjusted based on the response of macular edema as measured by optical coherence tomography.[2] Alternatively, an intravitreal injection of 6 mg can be administered every 4 weeks for the first 6 doses, followed by a 6 mg dose every 8 weeks over the next 28 weeks.[2]

Preparation

Faricimab is a 120 mg/mL solution in a single-dose vial that should be refrigerated prior to use.[2] Each vial contains more solution than necessary for administration of a single 0.05 mL dose of solution containing 6 mg of faricimab.[2] Before injection, the eye should be anesthetized with topical anesthetic and cleansed with betadine. The contents of the faricimab vial should be drawn using the provided 18 gauge needle. The 18 gauge needle should then be replaced with a sterile 30 gauge ½ inch needle for the injection.[2]

Clinical Trials

Faricimab has been the subject of multiple clinical trials to evaluate its safety and efficacy.

BOULEVARD

BOULEVARD, a phase 2 clinical trial, compared the safety and efficacy of faricimab with ranibizumab in patients with diabetic macular edema (DME).[3] Treatment-naive patients were randomized to intravitreal faricimab 6.0 mg, faricimab 1.5 mg, or 0.3 mg and patients with previous anti-VEGF treatment were randomized to 6.0 mg faricimab or 0.3 mg ranibizumab.[3] Patients were dosed monthly for 20 weeks then observed until week 36.[3] A total of 229 patients were enrolled. In treatment-naive patients, 6.0 mg faricimab demonstrated a statistically significant gain of 3.6 ETDRS letters over 0.3 mg ranibizumab.[3] Faricimab also demonstrated dose-dependent reductions in CST, improvements in diabetic retinopathy severity score (DRSS), and longer time to re-treatment during the observation period compared to ranibizumab.[3] The findings suggested a benefit in visual gain and potential for extended durability[4] of simultaneous inhibition of Ang-2 and VEGF-A in patients with DME.[3]

YOSEMITE and RHINE

YOSEMITE and RHINE are identically designed phase 3 clinical trials of faricimab in treatment-naive and previously anti-VEGF treated patients with center-involving diabetic macular edema.[4] The studies compared faricimab q8w after 6 initial q4w doses, faricimab personalized treatment interval (PTI) after 4 initial q4w doses, and aflibercept q8w after 5 initial q4w doses.[4] PTI is based on treat-and-extend and uses prespecified best-corrected visual acuity (BCVA) and central subfield thickness (CST) criteria.[4] The primary efficacy endpoint is the mean change in BCVA from baseline averaged over weeks 48, 52, and 56. One-year results were presented at ARVO 2021.[4]

TENAYA

LUCERNE

Efficacy

Adverse Effects and Safety

Warnings/Precautions

References

  1. 1.0 1.1 Khanani AM, Patel SS, Ferrone PJ, et al. 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;138(9):964–972. doi:10.1001/jamaophthalmol.2020.2699
  2. 2.0 2.1 2.2 2.3 2.4 2.5 Vabysmo prescribing information - gene.com. https://www.gene.com/download/pdf/vabysmo_prescribing.pdf. Accessed April 17, 2022
  3. 3.0 3.1 3.2 3.3 3.4 3.5 Sahni J, Patel SS, Dugel PU, et al. Simultaneous Inhibition of Angiopoietin-2 and Vascular Endothelial Growth Factor-A with Faricimab in Diabetic Macular Edema: BOULEVARD Phase 2 Randomized Trial. Ophthalmology. 2019;126(8):1155-1170. doi:10.1016/j.ophtha.2019.03.023
  4. 4.0 4.1 4.2 4.3 4.4 Wells JA, Wykoff CC, Willis JR, et al. Efficacy, durability, and safety of faricimab in diabetic macular edema (DME): one-year results from the phase 3 YOSEMITE and RHINE trials. Investigative Ophthalmology & Visual Science. 2021;62(8):1037.
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