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Karen Meerovitch, Gail Torkildsen, John Lonsdale, Heidi Goldfarb, Teresa Lama, Garth Cumberlidge, George W. Ousler, III; Safety and Efficacy of Topical Ophthalmic MIM-D3, a Novel TrkA Receptor Agonist, in a Phase 2 Clinical Trial for the Treatment of Dry Eye. Invest. Ophthalmol. Vis. Sci. 2012;53(14):578.
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To assess the safety and efficacy of low and high concentration doses of MIM-D3 Ophthalmic Solutions compared to placebo for the treatment of the signs and symptoms of dry eye.
A multi-center, randomized, double-masked, placebo-controlled study included a 7-day run-in period and 28 days of twice daily (BID) dosing. For screening purposes, at Visits 1 and 2 subjects were exposed to the Controlled Adverse Environment (CAE) chamber. Subjects were dosed BID with artificial tears between Visits 1 and 2. Eligible subjects had sufficient dry eye signs and symptoms pre-CAE at both visits as well as exacerbation in fluorescein corneal staining and ocular symptoms with CAE exposure. Patients were randomized (1:1:1) into three arms: low dose, high dose, or placebo. Symptoms were recorded daily in diaries. CAE exposure was repeated at Days 14 and 28 to assess treatment efficacy. Safety evaluations were performed at baseline and throughout the study.
In patients with moderate signs and symptoms of dry eye (n=150, mean age 58.2 years) both doses of MIM-D3 showed significantly less fluorescein staining than placebo after 28 days of treatment. Improvements in staining were observed in the post-CAE and changes from pre- to post-CAE analyses. Fluorescein staining scores in the low dose MIM-D3 arm were significantly lower than the scores in the placebo arm for the inferior, temporal, nasal, total cornea, conjunctiva and whole eye assessments (p=0.0039 to 0.0422). The mean dryness score in the symptom diaries over the 28-day treatment period for the high dose MIM-D3 arm was significantly lower than the score in the placebo arm (p=0.0342). In a subgroup defined by higher symptom scores during the run-in period, significant treatment effects for dryness (p=0.0150) and worst symptom (p=0.0368) were noted in the low dose MIM-D3 group, as well as for ocular discomfort (p=0.0140) in the high dose MIM-D3 group. Both doses of MIM-D3 appeared to be safe and well tolerated.
Topical ophthalmic MIM-D3 showed robust protection against the exacerbation of signs in the CAE model, and patient reported diary symptoms in the environment, with a favorable safety profile. MIM-D3 demonstrates promising results as a novel treatment for dry eye disease.
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