Clinical Data

Clinical Data for iLink

Three prospective, randomized, sham-controlled US phase III pivotal trials were conducted to evaluate the safety and effectiveness of Photrexa® Viscous (riboflavin 5’-phosphate in 20% dextran ophthalmic solution), Photrexa® (riboflavin 5’-phosphate ophthalmic solution), and the KXL system for performing the iLink corneal cross-linking procedure in support of the FDA NDA submission.

US Phase III Clinical Trial
Data Primary Efficacy Endpoint

Progressive
Keratoconus

Mean Difference in
Kmax = 2.6 D

Meets definition of success,
p<0.0001

Corneal
Ectasia

Mean Difference in Kmax = 1.4 D
Meets definition of success,
p<0.0001

Primary endpoint met: ≥1 D difference in 12-month mean Kmax, treatment vs. control

*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.

US Phase III Clinical Trial Data:

Other Observed Findings

  • In the pooled analysis of keratoconus patients, 94% of iLink treated eyes showed improvement or remained within 2.00 D of baseline Kmax at 12 months [1].
  • In the pooled analysis of corneal ectasia patients, 97% of iLink treated eyes showed improvement or remained within 2.00 D of baseline Kmax at 12 months [2].

Safety

The majority of adverse events reported resolved during the first month. In 1-2% of patients, AEs continued to be reported at 12 months, including corneal epithelium defect, corneal edema, corneal opacity (haze) and corneal scar.

  • In keratoconus patients, the most common ocular adverse reactions in CXL-treated eyes were corneal opacity (haze), punctate keratitis, corneal striae, corneal epithelium defect, eye pain, reduced visual acuity, and blurred vision.
  • In corneal ectasia patients, the most common ocular adverse reactions were corneal opacity (haze), corneal epithelium defect, corneal striae, dry eye, eye pain, punctate keratitis, photophobia, reduced visual acuity, and blurred vision.

Citation:

  • Hersh PS, Stulting RD, Muller D, Durrie DS, Rajpal RK; United States Crosslinking Study Group. United States Multicenter Clinical Trial of Corneal Collagen Crosslinking for Keratoconus Treatment. Ophthalmology. 2017 Sep;124(9):1259-1270.
  • Hersh PS, Stulting RD, Muller D, Durrie DS, Rajpal RK; U.S. Crosslinking Study Group. U.S. Multicenter Clinical Trial of Corneal Collagen Crosslinking for Treatment of Corneal Ectasia after Refractive Surgery. Ophthalmology. 2017 Oct;124(10):1475-1484.

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