An orally administered drug clinically trialled to treat people with Diabetic Macular Edema has resulted in significant improvements in both vision and retinal swelling for patients who were unresponsive to the approved intraocular injection therapies.
The OptimEyes trial was a multiple site, randomised, placebo controlled, parallel, double masked study to evaluate the safety and efficacy of two doses of oral Optina (adjusted to body mass index- BMI) in adult patients with Diabetic Macular Edema (DME). Optina has been developed by Ampio Pharmaceuticals.
The study showed 53 per cent of patients included in the trial who were refractory (unresponsive) to the approved intraocular injection therapies showed a significant +6.2 letter improvement in visual acuity over the three-month period of the study (P< 0.001). The remaining 47 per cent of patients who were unable or unwilling to have eye injections, 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.
Additionally the study showed significant improvements in visual acuity; the patients had a significant decrease in retinal swelling of 46 microns (p=0.003). Again, the placebo group failed to show a significant change in retinal swelling (-12 microns, p=0.47).
The study found that orally administered Optina was extremely safe with no drug related serious adverse events. There were no differences in side effect rates between placebo and the Optina arms.