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Keratoconus: US-approved treatments and how families in the Gulf can access them

Name: Keratoconus: US-approved treatments and Gulf access | Reserve Meds
Creator: Reserve Meds
Published: 2026-10-17

A plain guide for families in the Gulf, checked against US FDA labels, US National Institutes of Health information, Gulf drug registers and published research on 17 October 2026.

Reviewed by the Reserve Meds clinical operations team on 17 October 2026.

Keratoconus: the short answer

The US FDA has approved two medicines covered on this page for keratoconus, each for a specific group of patients: Photrexa Cross-linking Kit and Epioxa cross-linking. On 17 October 2026, none of them was on the Saudi or Abu Dhabi register we checked. Where a medicine is not registered, the treating hospital can ask the national regulator to import it for one named patient. Reserve Meds is a digital health company that helps with that process. We do not diagnose or prescribe.

US FDA-approved medicines on this page: Photrexa Cross-linking Kit and Epioxa cross-linking.
Gulf registers (checked 17 October 2026): see each medicine below.
Legal route: local supply where listed; otherwise a named-patient import request filed by the treating hospital; cell and gene therapies at a qualified center.
Price: Quote on request.

What is keratoconus?

Keratoconus is an eye condition in which the cornea, the clear front covering of the eye, thins and bulges outward into a cone shape. The changes worsen over time and can lead to nearsightedness, blurred vision that glasses cannot correct (irregular astigmatism) and vision loss.^[1]

Keratoconus may affect only one eye at first, but eventually both corneas become misshapen, though not always to the same degree. It is estimated to affect 1 in 500 to 2,000 people worldwide.^[1]

Corneal collagen cross-linking uses riboflavin eye drops, which act as photoenhancers, together with a light-delivery system during an eye procedure. Two cross-linking systems are approved in the US for progressive keratoconus, and they are performed by an eye surgeon.^{[2, 3]}

Keratoconus in the Gulf

Keratoconus is widely studied in Saudi Arabia, including demographic and clinical variations in the Saudi population (2022), its epidemiology in Najran Province (2021), and screening in a high-risk adolescent population (2021).^{[4, 5, 6]}

We checked every medicine on this page against the full SFDA drugs list and the Abu Dhabi Department of Health drug code list on 17 October 2026. 0 of 2 were listed in Saudi Arabia and 0 of 2 in Abu Dhabi. The result for each medicine is shown below. A listing does not mean every hospital stocks the medicine, and federal UAE, Kuwait, Qatar, Bahrain and Oman registers were not checked.^{[7, 8]}

US FDA-approved medicines for keratoconus

Each medicine below is approved in the US for a specific group of patients. The wording summarizes the current US label. Your specialist decides whether any of them is right for the patient.

Photrexa Cross-linking Kit (riboflavin 5'-phosphate ophthalmic solution)
US FDA-approved for corneal collagen cross-linking with the KXL System for progressive keratoconus and corneal ectasia after refractive surgery. The epithelium is removed during the procedure.^[2]
Current US label version: 24 July 2026. Gulf registers: Saudi Arabia (SFDA drugs list): not found. Abu Dhabi (DoH drug code list): not found. Checked 17 October 2026. Federal UAE, Kuwait, Qatar, Bahrain and Oman: not checked; we confirm for your country when you ask.^{[7, 8]}
Epioxa cross-linking (riboflavin 5'-phosphate ophthalmic solution)
US FDA-approved for epithelium-on corneal collagen cross-linking for keratoconus in adults and children 13 and older, used with the O2n System and Boost Goggles.^[3]
Current US label version: 18 November 2025. Gulf registers: Saudi Arabia (SFDA drugs list): not found. Abu Dhabi (DoH drug code list): not found. Checked 17 October 2026. Federal UAE, Kuwait, Qatar, Bahrain and Oman: not checked; we confirm for your country when you ask.^{[7, 8]}

How families in the Gulf can access treatment

If it is not registered. The usual legal route is a named-patient request: the treating hospital, on your specialist's written request, asks the national regulator for permission to import the medicine for one patient, using the US FDA approval as the reference. In Saudi Arabia the SFDA Special Access Program guidance covers these requests; in Bahrain, NHRA Circular 41 of 2020 sets the procedure. Other Gulf countries have their own procedures, which the hospital confirms.^{[9, 10]} Once approval is in place, Reserve Meds arranges supply through a US-licensed pharmaceutical wholesale partner to the hospital.

For Photrexa Cross-linking Kit and Epioxa cross-linking. These are made for one patient or given through a specialized procedure, so treatment happens at a qualified center. For most Gulf families that means a referral from the treating specialist to a center that can give the treatment, which may be abroad. A local hospital can only give it if the manufacturer agrees to supply that hospital and the regulator approves. We cannot promise that a manufacturer will agree.

Who does what

Your treating specialist decides whether a medicine is right for the patient and writes the medical letter.
The hospital checks local supply, files any import request, and gives the treatment safely.
The national regulator decides whether to approve the import of a medicine that is not registered.
The manufacturer decides where its medicine can be supplied, especially for cell and gene therapies.
Reserve Meds helps organize records, coordinates US supply through our wholesale partner, shipping and updates to your family. We do not give medical advice.

Documents you will usually need

A letter from the treating specialist with the diagnosis, past treatments and why this medicine is being considered
Reports that confirm the diagnosis, such as genetic, pathology, imaging or laboratory results, translated into English where needed
Recent clinic notes and a list of current medicines
For a hospital import request: the prescription, the hospital's request form and the written consent of the patient or guardian
Proof of the US FDA approval and the US prescribing information (we can supply these)

We give you a written timeline estimate for your case before you commit. The regulator, the hospital or treatment center and the manufacturer set their own timelines.

What treatment costs

Quote on request. Your total cost depends on the medicine, the dose, shipping, import steps and coordination. Your coordination fee is quoted in writing for your case before you commit. No hidden charges.

How Reserve Meds helps

Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We help your doctor and hospital prepare the file, arrange US supply and temperature-controlled shipping once approval is in place, and keep your family updated. We coordinate access to FDA-approved medicines only. Investigational medicines are only available through a manufacturer's expanded-access program requested by the treating physician; we can explain that route, but we do not supply them.

Ask us about treatment for keratoconus

Tell us the medicine, your country and a WhatsApp or phone number. We reply within one business day. On WhatsApp we usually reply the same day.

Frequently asked questions

Is there an FDA-approved treatment for keratoconus?

Yes. The medicines on this page have US FDA approval for specific groups of patients: Photrexa Cross-linking Kit and Epioxa cross-linking. The exact conditions are in each US label and are summarized above. Your specialist decides whether any of them fits.

Is Photrexa Cross-linking Kit available in Saudi Arabia or the UAE?

We checked on 17 October 2026. Saudi Arabia (SFDA drugs list): not found. Abu Dhabi (Department of Health drug code list): not found. A listing in Abu Dhabi does not show federal UAE status, which we could not verify. Your hospital confirms current supply.

How can a family in the Gulf get Photrexa Cross-linking Kit?

It is given at a qualified center. Your specialist refers the patient, the center checks eligibility, and the family plans funding and travel. A local hospital can only give it if the manufacturer agrees to supply it and the regulator approves.

How much does treatment cost?

Quote on request. Your total cost, including the medicine, shipping, import steps and coordination, is quoted in writing for your case before you commit. No hidden charges.

Does Reserve Meds diagnose or prescribe?

No. Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We do not diagnose, prescribe or decide what a regulator approves. Your specialist and hospital make the medical decisions.

Is cross-linking a medicine or a procedure?

Both. The riboflavin drops are the medicine and are activated by a special light device during an eye procedure. The approved drops must be used with their matching device, so it is done at an eye center that has the system.

Sources for the condition-specific answers: ^{[2, 3]}

Sources

Accessed and checked on 17 October 2026. Labels, registers and regulator rules change. Your hospital confirms the current position before anything is filed.

This page is general health information, not medical advice. It does not replace a consultation with your doctor.