Canadian biotechnology firm Mimetogen Pharmaceuticals has started patient enrolment in its Phase III clinical trial of MIM-D3, an ophthalmic solution drug, for the treatment of dry eye syndrome (keratoconjunctivitis sicca).
In the trial, around 400 patients will be randomised to receive 1% MIM-D3 ophthalmic solution or placebo twice daily over an eight week period, to further assess the safety and efficacy of the drug in the treatment of dry eye syndrome.
Safety and comfort of MIM-D3 compared to placebo will also be assessed in the trial, while its primary endpoints are corneal fluorescein staining score in the CAESM and ocular dryness.
Ophthalmic Consultants of Long Island ophthalmologist Eric Donnenfeld said dry eye is an extremely common condition that continues to grow as the population ages.
"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," Donnenfeld added.
"Current treatments have limited effectiveness for many patients and there is an increasing need for new therapies for dry eye.
"With its novel mechanism of action, MIM-D3 could provide an exciting option for the treatment of dry eye."
MIM-D3, a small molecule partial agonist of TrkA (neurotrophic tyrosine kinase receptor 1, NTRK1), is administered into the eye topically as an ophthalmic solution.
The drug stimulates the production of mucin, which are necessary for lubrication, removal of allergen, pathogens and debris, and corneal epithelial healing to reduce ocular surface damage.
Compared with the existing dry eye therapies, MIM-D3 is expected to help in improving neural function, which might enhance corneal sensitivity and integrity.
The new trial is based on positive data secured from the Phase II dry eye trial, which showed significant improvements in both signs and symptoms after 14 and 28 days of dosing.
Ora vice-president of Dry Eye George Ousler said: "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."
MIM-D3 is a small cyclic peptidomimetic of nerve growth factor (NGF), a naturally occurring protein in the eye that is responsible for the maintenance of corneal nerves and epithelium, mucin and tear production.
Previously, Bausch + Lomb has secured an option to license MIM-D3 for dry eye and if it chooses to pursue development of the drug based on the results of Phase III trial, the company will assume all development responsibilities and costs, and also pay development milestones, sales milestones and royalty fees to Mimetogen.
Dry eye is a multi-factorial disease of the tears and ocular surface, which results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface.