Liposome + Perilla + Sodium Hyaluronate

Approved and Clinically Accepted Indications:

• Dry Eye Syndrome (Keratoconjunctivitis Sicca): For the relief of ocular discomfort, burning, and irritation due to insufficient tear production or excessive evaporation.
• Meibomian Gland Dysfunction (MGD): Adjunctive therapy to restore the tear film lipid layer and enhance tear film stability.
• Ocular Allergies and Irritations: Provides soothing and anti-inflammatory benefits in allergic conjunctivitis, environmental irritation, or mild inflammation.
• Postoperative Ocular Surface Care: Aids in healing and hydration following cataract extraction, LASIK, or other ophthalmic procedures.
• Contact Lens Discomfort: Improves lens tolerance by lubricating the eye and restoring moisture.

Adults:

• Instill 1 to 2 drops in the affected eye(s) 2 to 4 times daily, or as directed by an ophthalmologist.
• In severe dry eye cases, dosing may be increased to every 1 to 2 hours, based on clinical need.

Pediatrics:

• Generally considered safe for children aged >3 years, under medical supervision.
• Dosing is the same as adults unless otherwise directed.

Elderly:

• No dose adjustment required.

Special Populations (Renal/Hepatic Impairment):

• No dose adjustment is needed, as the formulation acts topically with minimal systemic absorption.

Route of Administration:

• Topical ophthalmic use only.
• Do not touch the dropper tip to any surface, including the eye, to prevent contamination.
• Shake well before use if recommended on the packaging.

This ophthalmic combination product provides a multi-layered protective and therapeutic effect on the ocular surface. Liposomes reinforce the lipid layer of the tear film, reducing evaporation and improving tear film stability. Perilla extract, rich in anti-inflammatory polyphenols and flavonoids, helps counteract allergic and inflammatory stimuli at the ocular surface. Sodium hyaluronate acts as a humectant and lubricant, binding water molecules and providing long-lasting hydration, while supporting corneal epithelial regeneration. Together, these components restore tear film integrity, reduce irritation, and relieve symptoms of dry and inflamed eyes.

• Absorption: Minimal to no systemic absorption; primarily acts on the ocular surface.
• Distribution: Limited to corneal and conjunctival tissues.
• Metabolism: Not systemically metabolized due to topical route of administration.
• Elimination: Components are cleared through natural tear drainage; insignificant systemic exposure.
• Onset of Action: Symptomatic relief typically begins within minutes of instillation.

• Pregnancy: No FDA pregnancy category assigned. However, due to negligible systemic absorption, this combination is considered safe during pregnancy when used as directed.
• Lactation: The drug is unlikely to be excreted in breast milk. No adverse effects on breastfeeding infants have been reported. Use is considered safe during lactation.
• Caution: Pregnant or breastfeeding women should consult an ophthalmologist before using this product for prolonged periods.

• Primary Class: Ophthalmic Lubricant / Artificial Tear
• Subclass: Multi-functional tear film stabilizer with anti-inflammatory and moisturizing properties

• Hypersensitivity to liposomes, perilla extract, sodium hyaluronate, or any component of the formulation
• Active ocular infections (bacterial, viral, or fungal) unless used in combination with appropriate antimicrobial therapy
• Use of a contaminated or damaged bottle or vial

• Avoid touching the applicator tip to any surface to maintain sterility.
• Use with contact lenses: Some formulations may require removal of lenses before application. Reinsert lenses 15 minutes after instillation if applicable.
• Persistent or worsening symptoms: If symptoms do not improve or worsen, discontinue use and consult an ophthalmologist.
• Preservative-free formulations are preferred for patients requiring frequent or long-term use to reduce the risk of epithelial toxicity.
• Monitor for hypersensitivity reactions, especially with prolonged use.

Common (Usually mild and transient):

• Mild burning or stinging sensation upon instillation
• Blurred vision immediately after application
• Mild eye redness or irritation

Uncommon:

• Itching or swelling of the eyelids
• Increased tearing
• Sensation of a foreign body in the eye

Rare but Serious:

• Allergic conjunctivitis
• Hypersensitivity reactions
• Secondary infection due to contamination from improper handling

Timing & Severity:

• Most side effects are mild, dose-independent, and resolve spontaneously within minutes of application.

• No known systemic drug interactions due to negligible systemic absorption.
• If using multiple ophthalmic products, administer each at least 5–10 minutes apart to avoid dilution or interference.
• No known interaction with CYP450 enzyme systems or food/alcohol.

• TFOS DEWS II guidelines support the use of multi-component tear film supplements, including those with lipid-layer stabilizers and anti-inflammatory agents, in both aqueous-deficient and evaporative dry eye.
• Preservative-free and liposomal formulations are increasingly recommended in chronic dry eye due to improved safety for long-term use.
• Enhanced formulations with perilla extract are gaining attention for their natural anti-inflammatory effects in allergic eye disease and environmental irritant exposure.

• Temperature: Store at 20°C to 25°C (68°F to 77°F). Avoid exposure to temperatures above 30°C.
• Light Protection: Store in the original container and protect from direct sunlight.
• Humidity: Keep the bottle tightly closed when not in use to prevent contamination.
• Handling Precautions:
• Do not use if the solution becomes discolored or cloudy.
• Single-use containers: Discard immediately after use.
• Multi-dose bottles: Discard within 30 days after opening, or as per manufacturer’s label.
• Do not freeze.