Mimetogen starts patient enrolment in Phase III study of eye drug
Mimetogen Pharmaceuticals has started enrolment of patients in its Phase III clinical trial of MIM-D3 ophthalmic solution to treat patients with dry eye syndrome.
The new drug, which is the first in a class of molecules called TrkA agonists, stimulates the production of mucins that are necessary for lubrication, removal of allergen, pathogens and debris, as well as corneal epithelial healing to reduce ocular surface damage.
Additionally, MIM-D3 will help in improving neural function, which might enhance corneal sensitivity and integrity, compared to the existing dry eye therapies.
Around 400 patients will be randomized to receive 1% MIM-D3 ophthalmic solution or placebo twice daily over an eight week period during the trial which is aimed at further assessing the safety and efficacy of the drug.
The safety and comfort of the drug 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.
The Phase III 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."