Vabysmo Faricimab Injection

1. Indications and Usage
Neovascular (Wet) Age-Related Macular Degeneration (nAMD):
Treatment of patients with nAMD.
Diabetic Macular Edema (DME):
Treatment of patients with DME.
Retinal Vein Occlusion (RVO):
Treatment of macular edema following central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO).
2. Dosage and Administration
Route of Administration:
For Intravitreal Injection ONLY. Must be administered by an ophthalmologist.
Recommended Dosage:
Dose: 6 mg (0.05 mL) per injection.
Schedule:
Initial Phase: Once every 4 weeks (monthly) for the first 3 months.
Maintenance Phase: Once every 8–16 weeks thereafter, based on disease activity.
Dosing Interval: The dosing interval may be extended up to 16 weeks using a Treat-and-Extend (T&E) regimen.
Critical Administration Instructions:
Sterile Technique: Administer under sterile conditions with appropriate anesthesia and topical broad-spectrum bacteriostatic agent.
Injection Site: Typically injected into the vitreous cavity (e.g., 3–4 mm posterior to the limbus).
3. Mechanism of Action
Dual-Antagonist Activity:
Faricimab is a bispecific IgG1 antibody that binds with high affinity to both VEGF-A and Angiopoietin-2 (Ang-2).
Pathway Inhibition:
Anti-VEGF-A: Inhibits pathological angiogenesis and reduces vascular permeability (edema), similar to existing anti-VEGF therapies.
Anti-Ang-2: Stabilizes blood vessels. Ang-2 destabilizes vessels and primes them for leakage; inhibiting it strengthens vessel integrity and reduces inflammation.
Therapeutic Result: Dual pathway inhibition provides enhanced and potentially more durable disease control compared to single-pathway inhibition.
4. Safety and Warnings
Endophthalmitis and Retinal Detachment:
Intravitreal injections carry a risk of intraocular infection and retinal detachment.
Intraocular Pressure (IOP) Spikes:
IOP may increase transiently immediately following injection.
Thromboembolic Events:
Non-fatal stroke, myocardial infarction, or vascular death may occur.
Contraindications:
Active or suspected ocular or periocular infections.
Severe active intraocular inflammation.
Hypersensitivity to the drug.
5.Adverse Reactions
Most Common:
Conjunctival hemorrhage, eye pain, vitreous floaters, cataract, and increased intraocular pressure.
Note: The safety profile is generally comparable to that of aflibercept.
6.Drug Interactions
No Clinical Significance:
No specific drug-drug interaction studies have been conducted. Concomitant use with other anti-VEGF agents is generally avoided.
7.Pharmaceutical Information
Chemical Composition:
Active Ingredient: Faricimab.
Appearance: Clear, colorless to slightly yellowish solution.
Packaging: Single-dose vial (6 mg/0.05 mL).
Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze or shake.