The news comes as the Vancouver-based firm said its UK partner Medicom Healthcare received the final certificate for the Canadian Medical Device Single Audit Program necessary to complete the regulatory submission for Health Canada approval.
Aequus said it expects to file for Canadian regulatory approval for the first three dry eye products in the Evolve line within the next 10 days.
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The dry eye drops will be filed as New Class II medical devices with Health Canada, which usually comes with an expected review period of up to 30 days, Acasti said in a statement.
“Over the past months, the marketing team has worked diligently to prepare for the launch of Evolve in Canada,” said Doug Janzen, CEO of Aequus.
Janzen said it was a “long and frustrating” wait for both the pharmaceutical company and Medicom, but the firm managed to utilize the time well and are ready to get to work.
“We are excited to have received this final piece required for the regulatory submission with Health Canada and look forward to providing dry eye patients in Canada with this exceptional line of products in the near future,” Janzen added.
Launched in 2015 in Europe, the Evolve brand has grown to five products across 35 countries. Its line includes a preservative-free prescription product for the treatment of open-angle glaucoma and a range of supporting diagnostics.
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