Dry eye disease (DED): cross-border specialty drug access for international patients

Quick orientation

Dry eye disease affects an estimated 5 to 50 percent of adults depending on definition. Clinically significant disease requiring prescription therapy affects an estimated 16 million Americans, with similar relative prevalence in many international markets.

Typical age of onset. Any age; prevalence increases with age and is higher in postmenopausal women.

Severity tiers. Symptoms range from mild dryness and irritation to debilitating visual disturbance and corneal damage.

Why specialty drugs for Dry eye disease (DED) are hard to access internationally

Several recent FDA approvals including preservative-free formulations and a perfluorohexyloctane ophthalmic solution are not yet registered in many international markets despite strong demand.

Treatments approved by the FDA

• Miebo (perfluorohexyloctane ophthalmic solution) — FDA approval: 2023. Mechanism: Anti-evaporative ocular surface drop. Route: Topical ophthalmic four times daily. US WAC ballpark: Approximately USD 800 to 1,200 per month. Country pricing: Saudi Arabia · Kuwait · Jordan · Bahrain · Lebanon.
• Tryptyr (acoltremon ophthalmic solution) — FDA approval: 2025. Mechanism: TRPM8 agonist that stimulates tear production. Route: Topical ophthalmic twice daily. US WAC ballpark: Approximately USD 800 to 1,200 per month. Country pricing: UAE · Bahrain · Oman.
• Restasis (cyclosporine 0.05 percent) — FDA approval: 2003. Mechanism: Calcineurin inhibitor. Route: Topical ophthalmic twice daily. US WAC ballpark: Approximately USD 400 to 600 per month.
• Xiidra (lifitegrast) — FDA approval: 2016. Mechanism: LFA-1 antagonist. Route: Topical ophthalmic twice daily. US WAC ballpark: Approximately USD 600 to 900 per month.

Cross-border pathways used for Dry eye disease (DED)

Most patients use one or more of the following regulatory pathways, depending on the destination country and the specific drug:

• Named Patient Program (NPP)
• Personal Import Scheme
• Cross-border Prescription

What your physician needs to know

• Confirm aqueous-deficient versus evaporative versus mixed dry eye.
• Document failure of artificial tears and lid hygiene.
• Screen for autoimmune dry eye and refer where Sjogren's syndrome is suspected.
• Some destination countries require ophthalmologist prescription for these products.

Common questions

Is Miebo available outside the US?

International registration is in early stages.

Can these drugs be combined?

Many patients use combinations under specialist guidance.

How long until improvement?

Symptomatic improvement is often seen within weeks; biological measures of disease can take 3 to 6 months.

What documents are required?

Ophthalmologist's prescription and clinical summary.

Can I get bigger pack sizes?

Standard pack sizes are dispensed; multi-month supply is supported subject to destination quantity limits.

Where Reserve Meds fits in

Reserve Meds is a cross-border specialty drug access platform. We support international patients whose prescribed FDA-approved medicine is not registered locally, is not reimbursed by their payer, or is otherwise unavailable through standard channels. For Dry eye disease (DED), our role is to coordinate the regulatory pathway, source the medicine from a DSCSA-compliant US wholesaler, and arrange validated cold-chain or controlled-temperature shipment to the destination country.

We do not replace your treating physician. We do not bill insurance. We operate a cash-pay model, and we work alongside the clinical team that knows your case. Every prescription is reviewed by a US-licensed pharmacist before dispense, and a US-licensed physician reviews the supply request before shipment.

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