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RESTYLANE® EYELIGHT™ Indications for Use

RESTYLANE® EYELIGHT™ is an injectable dermal filler used specifically for the correction of infraorbital hollows in patients over the age of 21. It contains hyaluronic acid (HA) crosslinked with BDDE (1.4-butanediol diglycidyl ether) and is designed to reduce the appearance of hollowing under the eyes, providing a more refreshed and youthful look. The presence of lidocaine (0.3%) helps to alleviate discomfort during injection.

Key Indications:

• Treatment of infraorbital hollows (under-eye hollowing).
• Provides volume restoration and correction in the periorbital area.

Dosage Information

The product comes as a sterile gel in a 1 ml syringe, with a concentration of 20 mg/mL of hyaluronic acid and 0.3% lidocaine. It is intended for use with a 29G needle or 25G-27G cannula, administered by a trained healthcare professional.

RESTYLANE® EYELIGHT™ Dosage Summary:

• Hyaluronic Acid Concentration: 20 mg/mL.
• Lidocaine Concentration: 0.3%.
• Syringe Volume: 1 ml.
• Recommended injection volume: Maximum of 1 mL per side per treatment session. If more than 1 mL is needed, a follow-up session is recommended.

The injection should be performed in the supraperiosteal plane for best results, and the infraorbital hollows are treated by placing the filler beneath the skin in a linear threading or fanning technique.

RESTYLANE® EYELIGHT™ Side Effects and Precautions

RESTYLANE® EYELIGHT™ has been shown to be safe in clinical studies, but as with all injectable dermal fillers, there are potential risks and side effects.

Common Side Effects:

• Redness, swelling, and bruising at the injection site.
• Tenderness, itching, or pain, typically resolving within 1-2 weeks.

Serious Side Effects:

• Intravascular injection can lead to vascular occlusion, which may result in necrosis, blindness, or stroke. Immediate medical attention is required if symptoms like blanching or vision changes occur during or after the procedure.
• Nodules or lumps may form if injected too superficially.
• Patients with severe allergies, particularly those allergic to gram-positive bacterial proteins or amide-type anesthetics, should avoid this product.

Precautions:

• Do not inject into blood vessels. Special care is needed in the periorbital area, as the risk of vascular complications is higher.
• Avoid use in areas with active inflammation, such as acne or rashes.
• Patients taking anticoagulants or NSAIDs may experience increased bruising.
• The safety of the product in pregnant or breastfeeding women and patients under 22 years has not been established.

RESTYLANE® EYELIGHT™ Clinical Studies or Real-World Outcomes

Clinical trials conducted in the U.S. demonstrated the safety and efficacy of RESTYLANE® EYELIGHT™ for correcting infraorbital hollows. The studies included 333 subjects across 16 centers, with 287 receiving treatment and 46 in the control group.

Efficacy Results:

• 87.4% of patients in the treatment group showed improvement in their infraorbital hollows, with at least a 1-point improvement on the Galderma Infraorbital Hollows Scale (GIHS) at 3 months post-treatment.
• The responder rate remained high at 86% at 6 months, 77.6% at 9 months, and 63.5% at 12 months.
• Patients and treating investigators rated overall aesthetic improvement as 79.8% at 12 months, with high levels of satisfaction reported.

Patient Satisfaction:

• Patients reported a high degree of satisfaction, with many noting a natural-looking correction of their under-eye hollows.
• Time to social engagement was short, with patients treated with a needle resuming social activities within 4 hours and those treated with a cannula within 12 hours.

RESTYLANE® EYELIGHT™ Drug Interactions

As with all dermal fillers, there is a risk of interaction with certain medications that can affect bleeding and bruising.

Key Drug Interactions:

• Anticoagulants and NSAIDs (e.g., aspirin) may increase the risk of bruising at the injection site.
• Patients using other local anesthetics or medications affecting platelet function should proceed with caution.

RESTYLANE® EYELIGHT™ Aftercare Instructions

Patients should follow these aftercare instructions to minimize side effects and ensure the best results:

Post-Treatment Guidelines:

• Avoid touching the treated area for at least 6 hours after injection to minimize the risk of infection.
• Refrain from applying makeup for 24 hours to prevent irritation.
• Use ice packs to reduce swelling, but avoid direct contact with ice if the area is still numb.
• Avoid exposure to sunlight, UV lamps, or extreme temperatures until any redness or swelling has subsided.

What to Expect:

• Most side effects, such as redness or bruising, resolve within 1-2 weeks. Swelling and discomfort may last up to 7 days.

Follow-Up Treatments

Restylane Eyelight treatments generally last between 6 and 12 months, depending on the individual patient and area treated.

Maintenance Recommendations:

• Follow-up treatments may be necessary to maintain optimal results, and healthcare providers should monitor patient outcomes.
• A touch-up session is recommended within one month if the desired aesthetic outcome is not achieved with the initial injection.