Is Faricimab approved by the FDA?

Faricimab ophthalmic was approved by the FDA on January 28, 2022. This approval covers its use in adults for treating neovascular age-related macular degeneration and diabetic macular edema.

How Faricimab Works

Faricimab is administered as an intravitreal solution, injected directly into the eye. It works by inhibiting the growth of abnormal blood vessels and reducing fluid leakage in the retina, which helps to preserve vision.

Usage and Dosage

The typical dosing schedules for Faricimab are as follows:

For Neovascular Age-Related Macular Degeneration:

• Initial Dosing: 6 mg intravitreally every 4 weeks for the first 4 doses.
• Maintenance Dosing: After the initial phase, dosing can follow one of three regimens:
  • Regimen 1: 6 mg at weeks 28 and 44.
  • Regimen 2: 6 mg at weeks 24, 36, and 48.
  • Regimen 3: 6 mg at weeks 20, 28, 36, and 44.

For Diabetic Macular Edema:

• Regimen 1: 6 mg intravitreally every 4 weeks for at least 4 doses. If edema resolves, the dosing interval can be adjusted based on clinical evaluations.
• Regimen 2: 6 mg intravitreally every 4 weeks for the first 6 doses, followed by every 8 weeks for the next 28 weeks.

Side Effects

Faricimab ophthalmic may cause several side effects. Serious side effects requiring immediate medical attention include:

• Signs of eye infection (swelling, severe discomfort, crusting, or drainage).
• Severe eye redness or pain.
• Increased sensitivity to light.
• Changes in vision.

Common side effects include:

• Blurred vision.
• Eye pain or redness.
• Seeing halos around lights.
• Bleeding in the white part of the eye.

Warnings and Precautions

• Contraindications: Do not use Faricimab if you have swelling or infection in or around your eye, or if you are allergic to the medication.
• Medical History: Inform your doctor if you have a history of heart attack, stroke, glaucoma, or any condition that increases pressure inside your eyes.
• Pregnancy and Breastfeeding: The effects on an unborn baby are unknown. Use effective birth control during treatment and for at least 3 months after the last dose. Consult your doctor if you are pregnant or plan to become pregnant, and avoid breastfeeding while using Faricimab and for at least 3 months after the last dose.

Administration

Faricimab is administered by a healthcare provider through an intravitreal injection. Patients will undergo frequent vision exams before and after treatment to monitor the drug's effectiveness and any potential side effects.

Conclusion

Faricimab ophthalmic (Vabysmo) is FDA approved as of January 28, 2022, for the treatment of neovascular age-related macular degeneration and diabetic macular edema in adults. This innovative treatment offers a significant option for patients suffering from these vision-impairing conditions, though it requires careful monitoring due to potential side effects.

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