The iLink Procedure

Left untreated, 1 in 5 patients with progressive keratoconus may require a corneal transplant. More than half of these patients could need multiple transplants within 20 years. 1, 2
[Pramanik] [Maharana]

Image of open eye.

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Clinical study data

In clinical studies, cross-linking–treated eyes showed increasing improvement in Kmax from month 3 through month 12, while in untreated, sham eyes, Kmax demonstrated steepening.3

[Photrexa package insert 2016/p9/fig1]

Change From Baseline (Kmax)—Progressive Keratoconus Patients*3

[Photrexa package insert 2016/p9/fig1]

Clinical study data chart.

*Post-baseline missing data were imputed using last available Kmax value. For the sham study eyes that received cross-linking treatment after baseline, the last Kmax measurement recorded prior to receiving cross-linking treatment was used in the analysis for later time points. In Study 3, 4 patients in the cross-linking group had missing baseline Kmax value and were excluded from the analysis.


References
1. Pramanik S, Musch DC, Sutphin JE, Farjo AA. Extended long-term outcomes of penetrating keratoplasty for keratoconus. Ophthalmology. 2006;113(9):1633-1638.
2. Maharana PK, Agarwal K, Jhanji V, Vajpayee RB. Deep anterior lamellar keratoplasty for keratoconus: a review. Eye Contact Lens. 2014;40(6):382-389.
3. Photrexa [package insert]. Waltham, MA: Glaukos, Inc. 2016.

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 epethelial 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 [package insert]. Waltham, MA: Glaukos, Inc. 2016