EYLEA® (Non-English)

EYLEA® (aflibercept) is a recombinant fusion protein formulated as an intravitreal injection to treat various retinal diseases caused by abnormal blood vessel growth and vascular leakage in the eye. It acts as a VEGF inhibitor, specifically binding to VEGF-A, VEGF-B, and placental growth factor (PlGF), preventing these from interacting with their native receptors. This action helps reduce retinal edema, neovascularization, and vision loss. EYLEA® is commonly indicated for patients with neovascular (wet) age-related macular degeneration (wAMD), macular edema after retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR), and retinopathy of prematurity (ROP). The product is administered under strict aseptic conditions by a trained ophthalmologist.

EYLEA® is administered via intravitreal injection using aseptic technique in a controlled clinical environment.

Key Features:

• Fixed dosing based on clinical indication
  
• Administered directly into the vitreous cavity of the eye
  

Dosing Schedules:

• wAMD: 2 mg every month for the first 3 doses, then every 2 months
  
• RVO: 2 mg monthly until improvement is achieved
  
• DME/DR: 2 mg every month for 5 injections, then every 2 months
  
• ROP: 0.4 mg (0.025 mL) intravitreally in neonates
  

Indications:

• Neovascular (wet) AMD
  
• Macular edema secondary to branch or central RVO
  
• Diabetic macular edema
  
• Diabetic retinopathy
  
• Retinopathy of prematurity
  

Contraindications:

• Active ocular infections
  
• Ocular or periocular inflammation
  
• Hypersensitivity to aflibercept or any excipient
  

Side Effects:

• Very common: Conjunctival hemorrhage, eye pain, vitreous floaters
  
• Serious: Endophthalmitis, retinal detachment, increased intraocular pressure, intraocular inflammation
  

Each mL of EYLEA® contains:

• Active Ingredient: Aflibercept 40 mg
  
• Excipients:
  
  • Sucrose 200 mg
    
  • Sodium chloride 3.5 mg
    
  • Polysorbate 20
    
  • Sodium dihydrogen phosphate monohydrate
    
  • Disodium phosphate heptahydrate
    
  • Water for injections
    

Each 0.05 mL injection delivers 2 mg aflibercept.

• Pre-filled syringe (0.1 mL, containing 2 mg aflibercept per 0.05 mL dose)
  
• Sterile single-use packaging
  
• May also be available as vials in certain markets
  
• Packaged with tamper-evident seal and instructions
  

Yes, EYLEA® is associated with some common and serious adverse effects related to intravitreal injection.

Common Side Effects:

• Conjunctival hemorrhage (up to 25%)
  
• Transient intraocular pressure elevation
  
• Eye irritation or pain
  

Serious Risks:

• Endophthalmitis
  
• Retinal detachment or tear
  
• Intraocular inflammation
  
• Rare: arterial thromboembolic events
  

Proper storage ensures the stability and sterility of the product.

• Store refrigerated: 2°C to 8°C
  
• Do not freeze
  
• Keep in original outer carton to protect from light
  
• Use immediately after opening
  
• Discard any unused portion after single use