Avedro announced the publication of 1-year safety and efficacy data from the randomized, controlled pivotal phase 3 clinical trials that supported the FDA approval of the second clinical indication for Avedro’s Photrexa Viscous (riboflavin 5’-phosphate in 20% dextran ophthalmic solution), Photrexa (riboflavin 5’-phosphate ophthalmic solution) and KXL System for the treatment of corneal ectasia following refractive surgery.
Results from the clinical trials, in which 179 patients with corneal ectasia were treated at multiple US sites, were published in Ophthalmology.
Data from the clinical trials demonstrated that Kmax improved by 0.7 D (±2.1 D) from baseline to 1 year in the cross-linking treated group and worsened by 0.6 D (±2.1 D) in the control group, for a difference between groups of 1.3 D (P<0.0001). Additionally, eyes treated with cross-linking had a mean gain of 5.0 logMAR letters over baseline CDVA, which was significantly different than the 0.3 letter loss in the control group (P<0.0001). UDVA improved 4.7 logMAR letters over the control group (P<0.001). Cross-linking was safe and well tolerated. Corneal haze was the most frequently reported cross-linking adverse event.
“Similar to the phase 3 keratoconus clinical trials, which were published last month in Ophthalmology, we saw significant improvements in the steepness of the cornea and visual acuity, as well as subjective improvements across several measures of visual function, such as improved night driving,” Peter Hersh, MD, lead author and cornea specialist at The Cornea and Laser Eye Institute – CLEI Center for Keratoconus, said in a company news release. “It is encouraging to see these results which offer physicians an excellent treatment option for this rare, but serious disease.”
“The publication of this second paper in Ophthalmology confirms the benefits of corneal cross-linking for patients with ectasia,” Rajesh Rajpal, MD, coauthor and Chief Medical Officer for Avedro, said in the news release. “The clinical trials demonstrated cross-linking decreased disease progression in this orphan disease and was safe and well tolerated. Avedro is committed to ensuring that patients with corneal ectasia and keratoconus have access to this sight-saving treatment and are working hard to study and develop new cross-linking technologies that provide additional benefit in the protection and improvement of vision.”
The randomized, controlled clinical trials included 179 patients with documented corneal ectasia following previous refractive surgery at 11 clinical study sites in the U.S. Eyes in the treatment group underwent standard epithelium-off corneal cross-linking with Photrexa Viscous and Photrexa riboflavin drops and 3mW/cm2 UVA light. Eyes in the control group received Photrexa Viscous but did not have the epithelium removed and did not receive UVA light. The primary efficacy criterion was the change over 1 year of topography-derived KMax, comparing treatment with the control group.