The US Food and Drug Administration (FDA) has approved a riboflavin ophthalmic solution (Photrexa, Avedro) that treats a corneal disease called progressive keratoconus with corneal collagen crosslinking, the manufacturer announced today.
The approval extends to a version of the riboflavin ophthalmic solution that contains dextran (Photrexa Viscous) and an electronic device (KXL System) that irradiates the solutions with ultraviolet A light after they have been applied to the cornea.
Keratoconus is a degenerative disease that causes progressive thinning and distortion of the cornea. The condition can result in myopia, astigmatism, and even blindness. Corneal collagen crosslinking aims to halt the progress of keratoconus by strengthening chemical bonds in the cornea. Successful crosslinking can avert the need for a corneal transplant.
In a news release, Avedro called its ophthalmic solution "a first-in-class therapeutic treatment for this sight-threatening indication."
The FDA determined that the new treatment for progressive keratoconus was safe and effective based on three 12-month clinical trials conducted in the United States, according to Avedro. In two of the studies, patients with the disorder were randomized to receive either the crosslinking therapy or a sham therapy in a designated eye. The eyes treated with the riboflavin ophthalmic solution showed increasing improvement from month 3 through month 12. In contrast, eyes receiving the sham therapy worsened during the study period.
Corneal opacity, punctate keratitis, corneal striae, corneal epithelium defect, and eye pain were among the most common adverse events observed in the studies. The manufacturer noted that ulcerative keratitis can occur with the treatment, and that clinicians should monitor patients for epithelial defects.
The company's corneal crosslinking technology is already available in Asia and Europe. In February 2015, an FDA advisory panel recommended approval in the US.
More information on riboflavin ophthalmic solution is available at the manufacturer's website.
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Cite this: FDA Approves Photrexa for Corneal Crosslinking in Keratoconus - Medscape - Apr 18, 2016.