MIM-D3 Phase 3 Study
Mimetogen is currently evaluating the safety and efficacy of MIM-D3 in the treatment of dry eye syndrome. MIM-725 is a multi-center, randomized, double-masked, placebo-controlled Phase 3 study designed to evaluate the safety, tolerability and efficacy of MIM-D3 in improving both the signs and symptoms of dry eye. 400 patients will be randomized to receive 1% MIM-D3 ophthalmic solution or placebo twice daily over an 8 week period. This study, MIM-725, has been listed with ClinicalTrials.gov (identifier NCT01960010)
Key eligibility criteria include moderate signs and symptoms of dry eye plus a demonstration of exacerbation of corneal fluorescein staining and ocular discomfort during exposure to the Controlled Adverse Environment (CAESM) on 2 separate visits.
Safety and efficacy will be evaluated throughout treatment. The CAESM will be used during the trial to produce a standardized adverse environmental challenge. Signs (fluorescein staining) and symptoms (patient reported ocular dryness) are primary outcome measures. Other outcome measures included are fluorescein and lissamine green stainingin each region of the eye and at different assessments, and patient reported diaries of individual symptoms (ocular discomfort, dryness, grittiness, burning and stinging).
MIM-D3 Phase 2 Study
Mimetogen completed a two-center, randomized, double-masked, placebo-controlled Phase 2 study to evaluate the safety, tolerability and efficacy of MIM-D3 in improving both the signs and symptoms of dry eye. 150 subjects were randomized 1 :1 :1 for 1% MIM-D3, 5% MIM-D3 and Placebo and dosed twice daily for 28 days. This study, MIM-724, has been listed with ClinicalTrials.gov (identifier NCT01257607)
Key eligibility criteria included moderate signs and symptoms of dry eye plus a demonstration of exacerbation in corneal fluorescein staining and ocular discomfort after exposure to the Controlled Adverse Environment (CAESM) on 2 separate visits.
Phase 2 Results
The trial demonstrated statistically significant improvements (p<0.05) in a number of key approvable signs and symptoms in the intent to treat (ITT) population together with excellent safety and tolerability profiles1.
Signs - Analysis of the ITT population showed MIM-D3 treated groups had consistent improvements across various measures of ocular staining compared to placebo over the 28-day study period. Improvements were robust, and stable to multiple analyses and multiple scoring regions (inferior, total cornea, conjunctiva, and whole eye). Significant improvements in staining were observed as early as 2 weeks after treatment. The significant improvements (p<0.05) shown in the ITT population indicate that treatment with MIM-D3 improved the overall health of the ocular surface, and provided a protective effect against environmental challenge.
Symptoms – Analysis of the ITT population showed that 28 days of treatment with both 1% and 5% MIM-D3 resulted in improvements in multiple symptom scores relative to placebo. A simple subgroup analysis, dividing the ITT population into 2 groups with initial symptom scores either less than or greater than the median, again showed that both 1% and 5% MIM-D3 improved symptoms over the 28-day period and that significant improvement (p<0.05) in the symptoms was generated versus the placebo group.
Safety – Topical administration of MIM-D3 in this trial was shown to be both safe and well-tolerated, ocular adverse events were mild and not considered treatment-related, and there were no concerns raised by any of the ophthalmic examinations.
- Meerovitch et. al., Clinical Ophthalmology 2013; 7:1275-1285.