Research into an blepharitis ointment has failed to achieve the primary endpoint in its Phase III trial, prompting the company behind it to reconsider the drug’s future.
A media release from US healthcare company Viatris said the Phase III study (NCT06400511) evaluated the efficacy and safety of its MR-139 (pimecrolimus 0.3%) ophthalmic ointment in 477 patients with the condition.
Blepharitis usually affects both eyes along the edges of the eyelids and results from clogged oil glands at the base of the eyelashes.
The release said the study failed to reach the primary endpoint of complete resolution of debris after six weeks of twice-daily dosing.
Viatris chief R&D officer Mr Philippe Martin said the company was working out its future plans for the product.
“Given that the study did not meet its objective for patients suffering from blepharitis, we are evaluating the appropriate next steps for the Phase III programme, which may include revising the planned additional Phase III study.”
There was better news for the company’s phentolamine ophthalmic solution 0.75%, which last month was successful in a second Phase III presbyopia study.
The company said it was now considering FDA approval of the therapy.
Viatris also had success in the Phase III LYNX-2 trial of MR-142 in keratorefractive patients experiencing visual disturbances under mesopic, low-contrast conditions.
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