In response to Photocure’s request for a special protocol assessment (SPA), the US FDA has agreed that the design and planned analysis of the pivotal Phase 3 protocols address the objectives in support of a regulatory submission. Ensuring regulatory alignment before initiating the Phase 3 registration trials reduces the risk of the development program and is an important milestone in the continued development of Cevira.
Kjetil Hestdal, President & CEO of Photocure, said: “Gaining alignment with the FDA on the Cevira registration program through the SPA process is a significant milestone in the continued development of this breakthrough technology. Cevira will offer a convenient and effective alternative to surgery in the large number of affected women globally, while preserving fertility and avoiding the potential for future neonatal morbidity and mortality which results from surgery.”
With alignment with FDA on Phase 3 clinical studies now obtained, Photocure plans to finalize necessary documentation for the Cevira device to ensure readiness for the Phase 3 trial. The Phase 3 registration program will consist of two identical double blind, randomized trials, each with approximately 200 patients, comparing Cevira to placebo in women with biopsy proven high-grade cervical lesions. The primary endpoint will be clearance of the high-grade lesion, as determined by an independent panel of pathologists, at six months.
For further information, please contact:
President & CEO Kjetil Hestdal
Tel: + 47 913 19 535, Email: firstname.lastname@example.org
CFO Erik Dahl
Tel: +47 450 55 000, Email: email@example.com