Imprimis Pharmaceuticals announced that its Canadian partner, Advanced Dosage Forms, will begin enrolling patients at McGill University Health Centre (MUHC) for a clinical trial of Imprimis’s leading Dropless (triamcinolone acetonide-moxifloxacin) formulation after a “No Objection Letter” was issued by Health Canada on January 4, 2018 and analytical tests required by Health Canada were completed July 11, 2018.
Additional patients will begin enrollment for the trial at Hôpital Maisonneuve-Rosemont on August 22, 2018. The prospective, randomized, controlled cross-over study of 200 bilateral cataract surgery patients will measure the outcomes of TriMoxi in one surgical eye versus traditional eye drop therapy in the same patient for the other surgical eye. The study may further efforts for public insurance payment for the formulation in Canada and in other markets.
“We are pleased to begin this multicenter prospective clinical trial for our leading Dropless formulation at Canada’s premier healthcare institutions, McGill University Health Centre and Hôpital Maisonneuve-Rosemont,” Mark L. Baum, CEO of Imprimis, said in a company news release. “The goal of the study is to clinically validate the experience of American ophthalmologists who have administered over seven hundred thousand doses of this formulation to cataract surgery patients over the past four years.”
John Di Genova, CEO of Advanced Dosage Forms, added, “Dropless has the potential of reducing or eliminating the need for post-cataract surgery topical eye drops for patients with physical and mental disabilities and others who cannot bear the burden of applying eye drops hundreds of times after ocular surgery. In the past 2 years, since partnering with Imprimis, Canadian ophthalmologists have seen this formulation work for thousands of Canadians and we are pleased to be able to formally study TriMoxi at two of the leading Canadian healthcare institutions, and hopefully offer it more broadly in Canada and other markets.”