iCo Therapeutics Inc. has announced the completion of drug product manufacturing activities as part of its Phase 2 clinical program investigating multiple doses and injections of iCo-007 in patients with diabetic macular edema (DME). Currently the market for this unmet medical condition is estimated to be US $800 million to US $1 billion in the United States alone.
iCo is evaluating potential clinical activities in several regulatory jurisdictions, including Canada, where the Company has received a No Objection Letter from Health Canada's Therapeutic Products Directorate related to its submitted Phase 2 DME clinical trial plan.
"We are pleased to have completed this critical stage," stated Andrew Rae, iCo's President & CEO. "An impressive array of clinicians from multiple clinical sites have been identified and solicited for their inputs and potential involvement in our next stage of development. iCo also continues to build strong relationships with philanthropic organizations and advocacy groups as a means of maximizing the potential data derived from the iCo-007 program but also return on capital to our shareholders.