iLink

Not all corneal cross-linking procedures are the same.

Lead the Way With iLink

When it comes to referring patients with progressive keratoconus for treatment, iLink is the only FDA-approved corneal cross-linking procedure.

Only iLink offers:

  • Confidence

    in your keratoconus treatment recommendation with proven efficacy and data

  • Coverage

    for over 95% of commercially insured lives

  • Consideration

    for the health of your patients and your peace of mind when making referrals

Explore iLink™ Information

FDA Approved

If it’s not iLink,
it’s not FDA approved

Don’t settle for less. There are several unapproved cross-linking procedures that healthcare providers might recommend or use without your knowing. These unapproved drugs and devices can put your patients’ safety, as well as your and your practice’s reputation, at risk.

Peschke Trade GmbH Import Alerts

The FDA has issued import alerts that include Peschke cross-linking devices and riboflavin. These products are illegal for importation and sale in the United States unless they are for a clinical investigation that is part of an FDA-approved investigational new drug (IND) application.

Not all cross-linking procedures are the same

Using any drug and device combination for corneal cross-linking other than iLink™ is not just off-label,* it’s unapproved.

The following chart compares the benefits of iLink with the risks of unapproved cross-linking. Keep scrolling to see more unfold.

FDA-Approved iLink™ Corneal Cross-Linking Unapproved Corneal Cross-linking

Approved by the FDA with pivotal clinical trial data and proven efficacy and safety

Safety and efficacy data have not been reviewed by the FDA, making the procedure unapproved

Coverage is available for over 95% of commercially insured lives1

Not covered by insurance—billing insurance for an unapproved procedure may be illegal or considered fraud1

Patients may be eligible for copay assistance through the iLink Copay Savings Program

Associated with greater patient out-of-pocket costs upwards of $6500

Incorporates rigorously tested and controlled Photrexa® (riboflavin 5’-phosphate ophthalmic solution) and Photrexa® Viscous (riboflavin 5'-phosphate in 20% dextran ophthalmic solution) riboflavin solutions1

Uses unapproved compounded riboflavin and/or riboflavin from Peschke Trade GmbH that is subject to an FDA import alert1

OMIC, the largest liability insurance carrier for ophthalmic providers, only covers FDA-approved procedures for commercial use. iLink is the only FDA-approved cross-linking procedure for progressive keratoconus, and it incorporates the KXL® system, Photrexa®, and Photrexa® Viscous2

OMIC advises policyholders that the commercial use of unapproved products may include risks they do not cover2

Offers patients peace of mind knowing their cross-linking procedure is approved by the FDA

Patients should be notified of the unapproved status of the procedure and that there is an FDA-approved option available2

Safety and efficacy are supported by pivotal trial data and numerous clinical studies that are detailed on ClinicalTrials.gov

Should be done with American IRB oversight and an FDA-approved IND application.2 Physician-sponsored studies (with compounded riboflavin) being listed on ClinicalTrials.gov does not ensure that the study is part of an FDA-approved IND

Photrexa® and Photrexa® Viscous are manufactured under FDA requirements of good manufacturing practice and are not compounded

The FDA does not verify the safety, effectiveness, or quality of unapproved compounded drugs before they are marketed. Compounded drugs may not be subject to current good manufacturing practice requirements3

Performed epithelium-off, allowing for Photrexa® and Photrexa® Viscous riboflavin solutions to permeate into the cornea and form strong collagen cross-links1

Currently, there are no riboflavin solutions approved by the FDA for epithelium-on procedures

The KXL® system is the only FDA-approved corneal cross-linking device

Unapproved devices may be modified or illegally imported with no postmarket surveillance1

Adverse events are documented in the iLink Important Safety Information

Do not require reporting on adverse events

As a Glaukos procedure, iLink offers confidence and consideration for the safety and peace of mind of your patients.

OMIC=Ophthalmic Mutual Insurance Company; IND=investigational new drug; IRB=institutional review board.
*Off-label means an FDA-approved product is being used for an unapproved use.
†Unapproved means that the FDA has not approved the product, determined the drug is safe and effective, or provided any labeling with information that can help patients avoid serious adverse events.

The word is out and insurers have listened

The word is out and insurers have listened

The medical necessity of iLink is widely recognized for the treatment of progressive keratoconus. As a result, the majority of insured patients in the United States are covered for the procedure.

Over 95%
of commercially insured lives are eligible for insurance coverage for iLink.

Locate an iLink™ Expert

iPath360 Reimbursement Program

Copay Assistance

The Glaukos Copay Savings Program provides eligible patients up to $200 per eye toward their non-reimbursable expenses for the FDA-approved iLink cross-linking procedure.

Learn More

Provider Assistance

The iPath360 program from Glaukos is connecting providers with the reimbursement support they need to ensure patients can get treated with the FDA-approved iLink cross-linking procedure.

Explore iPath 360 Resources

Refer for iLink™ today

Choosing a referral partner who values proven patient outcomes as much as you do has never been easier. iLinkExpert.com connects referring physicians with trusted specialists who offer the FDA-approved iLink procedure.

Find an iLink™ Expert

References

  1. Glaukos Data On File. 2020.
  2. I have patients with post-refractive ectasia who might benefit from corneal collagen cross-linking with riboflavin (CXL/C3-R). Will OMIC cover this treatment? Ophthalmic Mutual Insurance Company. Updated April 22, 2019. Accessed May 21, 2021. https://www.omic.com/policyholder/i-have-patients-with-post-refractive-ectasia-who-might-benefit-from-corneal-collagen-crosslinking-with-riboflavin-c3-rcxl-will-omic-cover-this-treatment.
  3. Compounding and the FDA: Questions and answers. US Food and Drug Administration. Accessed May 21, 2021. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers.

Using Photrexa® Viscous (riboflavin 5’-phosphate in 20% dextran ophthalmic solution), Photrexa® (riboflavin 5’-phosphate ophthalmic solution), and the KXL® System, the iLink™ corneal cross-linking procedure from Glaukos is the only FDA-approved therapeutic treatment for patients with progressive keratoconus and corneal ectasia following refractive surgery.*1

[Photrexa IFU/p1/col1/para3/lines1-4]

Indications

Photrexa® Viscous (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) and Photrexa® (riboflavin 5’-phosphate ophthalmic solution) are indicated for use with the KXL System in corneal collagen cross-linking for the treatment of progressive keratoconus and corneal ectasia following refractive surgery.

Important Safety Information

Corneal collagen cross-linking should not be performed on pregnant women.

Ulcerative keratitis can occur. Patients should be monitored for resolution of epithelial defects. The most common ocular adverse reaction was corneal opacity (haze). Other ocular side effects include punctate keratitis, corneal striae, dry eye, corneal epithelium defect, eye pain, light sensitivity, reduced visual acuity, and blurred vision.

These are not all the side effects of the corneal collagen cross-linking treatment. For more information, go www.livingwithkeratoconus.com to obtain the FDA-approved product labeling.

You are encouraged to report all side effects to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

*Photrexa® Viscous and Photrexa® are manufactured for Avedro. The KXL® System is manufactured by Avedro. Avedro is a wholly owned subsidiary of Glaukos Corporation.

Reference

1. Photrexa Prescribing Information. Waltham, MA: Glaukos, Inc. 2018