Dompé to expand commercial operations for Oxervate to Canada

14 October 2021

Privately-held Italian biopharma company Dompé Farmaceutici and its Dompé US Inc unit are planning to expand commercial operations for Oxervate (cenegermin ophthalmic solution) to Canada.

Preparations to enter the market started earlier in 2021 and recently the Human Drug Advisory Panel (HDAP) of Canadian Patented Medicine Pricing Review Board (PMPRB) recommended the classification of Oxervate as providing a Breakthrough Level of Therapeutic Improvement for the treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults.

The European Commission has granted a marketing authorization for Oxervate (eye drops) for the treatment of moderate to severe neurotrophic keratitis in July 2017, and the US Food and Drug Administration did likewise in August 2018.

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