Ampio Pharmaceuticals announced positive results from the OptimEyes Trial for Optina in patients with diabetic macular edema (DME).
The OptimEyes trial was a multicenter, randomized, placebo controlled, parallel, double masked study designed to evaluate the safety and efficacy of two doses of oral Optina (adjusted to BMI) in adult patients with DME. The trial enabled researchers to identify a subgroup of patients based on BMI (n=106 eyes) in which treatment with the optimal Optina dose resulted in significant improvements in both vision and retinal swelling.
Overall, 53% of patients included in the trial were refractory to the approved intraocular injection therapies. These refractory patients showed a significant +6.2 letter improvement in visual acuity over the three month period of the study (P<0.001). In the remaining 47% patients who were unable or unwilling to have eye injections, they showed a significant +3.1 letter improvement over the same period (P=0.04). The placebo group failed to achieve a significant increase in visual acuity in either of the subgroup of patients who were and were not refractory to intraocular injections over the same time period (+2.0 letters, P=0.20 vs. +0.7 letters, P=0.72, respectively). In addition to showing significant improvements in visual acuity, the patients had a significant decrease in retinal swelling of 46 microns (P=0.003). The placebo group did not show a significant change in retinal swelling (-12 microns, P=0.47).
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