iCo Therapeutics Inc. announced that at the midpoint of its Phase 2 iDEAL study for the treatment of diabetic macular edema (DME), there have been no drug related serious adverse events among patients receiving repeat doses of iCo-007. The company also announced that it has exceeded its recruitment threshold of patients for statistical analysis of the study and expects to announce final data for the primary endpoint in the fourth quarter of 2013. Diabetic macular edema is the swelling of the retina in diabetes patients due to leaking blood vessels within the macula, the central portion of the retina that is critical for daytime vision.

DME is the cause of blindness in working-age adults and affects approximately 1.6 million people in the U.S. alone, a number that is expected to grow as diabetes is forecast to increase by almost 50% in the US by 2025. There is currently only one approved drug for DME - ranibizumab, also known as Lucentis - which requires monthly injections. The trial explores whether varying combinations and concentrations of iCo-007 are effective in improving visual acuity in DME patients.

The Phase 2 clinical trial is studying patients at 26 clinical sites across the United States. The iDEAL study follows patients for a 12 month period. During the trial, patients are randomized into one of the following four groups: iCo-007 monotherapy (350ug), iCo-007 monotherapy (700ug), iCo-007 (350ug) and laser photocoagulation, iCo-007 (350ug) and ranibizumab (0.5mg).

The primary endpoint of the iDEAL trial is a change in visual acuity from baseline to month eight. Secondary endpoints include: visual acuity at month 12; retinal thickness as measured by optical coherence tomography (OCT) at month eight and 12; duration of the effect of iCo-007 at month 12; and safety. In keeping with good clinical practice, iCo management has not requested, examined or analyzed any efficacy or primary or secondary endpoint data, other than safety reports that are related to the company reporting requirements.