The OptimEyes trial, with FDA guidance, was designed to include a wide variety of DME patients, some of whom had no therapeutic options and were progressing to blindness. Intraocular injections may have been contraindicated in these patients (example-patients with glaucoma, prior vitrectomy etc…and were included in our trials).
Including patients not accepted in other trials of intraocular injections allowed us to better understand the effect of oral Optina in improving visual acuity (measured as best corrected visual acuity-BCVA, eye chart) and reducing edema (as measured by optical coherence tomography-OCT) in all patients.
The goal of the study was to assess the safety and efficacy of oral Optina, identify the patients who respond and the ideal dose.
- 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.
- Furthermore, we successfully identified 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. Results for this group are as follows:
- Overall, 53% of patients included in the trial were refractory (unresponsive) 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, +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). Again, the placebo group failed to show a significant change in retinal swelling (-12 microns, p=0.47).
Our plan is to continue the analysis, present the data to the FDA and once regulatory guidance is received, detailed information through appropriate channels such as conferences and publications will be distributed.