Restasis 0.05% Ophthalmic Emulsion contains cyclosporine 0.05% w/v in a sterile emulsion. This prescription immunomodulator is used to increase tear production in patients with dry eyes caused by ocular inflammation (keratoconjunctivitis sicca). It is supplied in single-dose and multidose containers.
Key Features
| About Restasis 0.05% Ophthalmic Emulsion | |
|---|---|
| Drug Class | Immunomodulator |
| Subclass | Topical ophthalmic agent |
| Product Details | |
|---|---|
| Composition | Active ingredient: Cyclosporine Inactive ingredients:
|
| Packaging Type | Single use vials |
| Pack Size | 30 single use vials |
| Dosage | 1 drop in each eye twice a day |
| Therapeutic class | Ophthalmic anti-inflammatory, Immunosuppressive agent |
| Action Class | Calcineurin inhibitor |
| Chemical class | Cyclic polypeptide |
| Manufacturer | Allergan |
| Shelf Life | 2-3 years from manufacturing date |
| Usages | Treatment of chronic dry eye; increases tear production; reduces inflammation |
| Country of Origin | USA |
| Storage | Store at room temperature (15-30°C), away from moisture and sunlight |
How Restasis (cyclosporine) Works
Cyclosporine is an immunomodulator that reduces T-cell-mediated inflammation on the ocular surface, interrupting the inflammatory cycle and restoring healthier tear production over time rather than just replacing tears. Clinical benefits accrue gradually with consistent use.
Indications / Uses
- Keratoconjunctivitis sicca (chronic dry eye): Indicated for patients whose tear production is suppressed by inflammation associated with dry eye disease. Used as part of a comprehensive management plan.
Restasis treats inflammation — it does not simply lubricate the eye with artificial tears.
Dosage & How to Use
- Typical dosing: 1 drop in each eye, twice daily (about 12 hours apart).
- Preparation: Invert single-dose vials before use to mix the emulsion. Do not touch vial tip to eye.
- Administration: Wash hands, tilt head, pull lower eyelid, instill drop; avoid vial tip contact; discard after use. Follow dispenser instructions for multidose packaging.
- Contact lenses: Remove before use and wait at least 15 minutes before reinserting lenses.
Improvement is gradual; tear production increases around 3 months, with continued benefit at 6 months and ongoing therapy.
Expected Benefits
- Increased tear production: Improves natural tears for those with inflammation-driven dryness.
- Reduced inflammation: Diminishes ocular inflammation, restoring surface and gland function.
- Comfort and stability: Improves comfort and visual clarity for daily tasks.
Side Effects
Most side effects are local:
- Burning or stinging after instillation (very common).
- Redness, irritation, discharge, watering, itching, foreign-body sensation.
Less common:
- Blurred vision immediately after use.
- Rare: Hypersensitivity or allergic reaction.
- Risk of infection if applicator tip contacts the eye.
Seek care for severe pain, vision loss, or serious symptoms.
Interactions & Important Clinical Notes
- Wait ~15 minutes between Restasis and other eye drops.
- Remove lenses before use and wait before reinserting.
- Systemic interactions are unlikely; discuss with your doctor if on other immunosuppressants.
Pharmacokinetics
Emulsion is designed for local delivery with very low systemic absorption. Formulation excipients help keep the drug stable and effective for ocular surface use.
Precautions & Who Should Be Careful
- Do not use if allergic to cyclosporine or any ingredient.
- Treat active ocular infections before starting.
- Discuss use if you have severe surface disease or prior eye surgery.
- Pregnancy & breastfeeding: Use only after risk/benefit discussion with clinician.
Storage & Handling
- Follow label instructions. Discard single-use vials after opening. Use multidose only as directed. Keep away from children.
Practical Tips & Realistic Expectations
- Apply consistently twice daily; missing doses slows progress.
- May be combined with artificial tears, environmental changes, and lid care.
- Initial stinging may fade over time but contact provider if discomfort persists.
- Months of continuous therapy may be required for full effect; stopping leads to reversal.
Comparison with Alternatives
Other prescriptions for dry eye (e.g., lifitegrast/Xiidra) have different mechanisms. Choice depends on individual needs; consult your provider for guidance.
Conclusion
Restasis 0.05% is an established topical cyclosporine treatment for chronic inflammation-driven dry eye, improving tear production over time. Gradual benefits require ongoing management. Safety profile is dominated by local reactions; serious events are rare with proper use. Always use under medical supervision.
References
- https://pmc.ncbi.nlm.nih.gov/articles/PMC4420022/
- https://pubchem.ncbi.nlm.nih.gov/patent/US-2010016219-A1
Janelle Crasto –
I tried Restasis Ophthalmic Emulsion, and it really helped with my dry eyes. After regular use, I noticed better comfort and less irritation