The Phase I, open-label, dose escalation study is evaluating the safety, tolerability, and pharmacokinetics of a single intravitreal injection of iCo-007 in patients with diffuse diabetic macular edema (DME).
The primary objective of the study is to evaluate the safety and tolerability of intravitreal iCo-007 in patients with diffuse DME. Other objectives include assessment of systemic pharmacokinetics, changes in retinal thickness using optical coherence tomography measurements, and changes in visual acuity.
The advancement from one cohort to the next is dependent upon the trial’s Safety Evaluation Committee approval. iCo is mid-way through the trial and the Safety Evaluation Committee has approved advancement to the third cohort. To date, there have been no adverse events of concern.
Andrew Rae, president and CEO of iCo, said: “We are greatly encouraged by the rolling data we are seeing from the trial. As this trial is in diffuse DME patients rather than healthy volunteers, we are able to get a better indication of the potential of iCo-007 compared to traditional Phase I trials.”