Mimetogen Pharmaceuticals Inc., announced that its first Phase 3 clinical study of MIM-D3 ophthalmic solution for the treatment of dry eye syndrome is now enrolled.
MIM-D3, the first in a class of molecules called TrkA agonists, stimulates the production of mucin. The treatment may have the potential to improve neural function, which may improve corneal sensitivity and integrity.
The study, which will further evaluate the safety and efficacy of MIM-D3 for the treatment of dry eye syndrome, will include approximately 400 patients who will be randomized to receive 1% MIM-D3 ophthalmic solution or placebo twice daily over an eight-week period.
"This pivotal Phase 3 study aims to build upon the positive results observed in the Phase 2 dry eye trial, which demonstrated significant improvements in both signs and symptoms after 14 and 28 days of dosing", said Garth Cumberlidge, PhD, Mimetogen’s CEO.
MIM-D3 will be studied using Ora’s Dry Eye System which addresses the challenges of studying dry eye disease, such as environmental and seasonal variability, through a combination of scientific and operational methods.
“This drug has a unique mechanism with a broad spectrum of effects on the ocular surface that should be of benefit to a wide range of dry eye patients,” says Eric Donnenfeld, MD, of Ophthalmic Consultants of Long Island. "Current treatments have limited effectiveness for many patients and there is an increasing need for new therapies for dry eye."
Bausch & Lomb previously acquired an option to license MIM-D3 for dry eye. Should Bausch & Lomb choose to pursue development based on the Phase 3 study results, the company will assume all development responsibilities and costs, and also will pay development milestones, sales milestones and royalty fees to Mimetogen.