Cambium Bio (ASX:CMB) secured ethics approval to begin its registration-enabling phase three clinical trials of Elate Ocular treatment candidate for the treatment of moderate to severe dry eye disease in both Australia and the US, according to a Monday Australian bourse filing.
The ethics approval in Australia was granted by Bellberry Human Research Ethics Committee on June 26, while the approval in the US was granted by Advarra Institutional Review Board on May 9.
The first patient dosing is anticipated in October, and it will randomize around 800 patients globally. The co-primary endpoints include improvement in total corneal fluorescein staining and eye discomfort VAS score, relating to dry eye disease.
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