Avedro and the FDA have reached a special protocol assessment agreement for the design of a pivotal phase 3 clinical trial of epithelium-on corneal collagen cross-linking for patients with progressive keratoconus, according to a press release.
According to the agreement, the trial design “adequately” addresses objectives, and if those objectives are met, they would form the basis of the submission to the FDA for approval of the epi-on cross-linking treatment.
The multicenter, randomized, controlled KXL308 phase 3 trial will evaluate the novel, accelerated cross-linking procedure in
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