CoMentis initiates trial for eye drop therapy

This phase II study is designed to evaluate the safety and efficacy of the eye drop, ATG3, in patients with age-related macular degeneration (AMD). All patients will be monitored for safety, tolerability and efficacy assessments. Patients will be assessed for change in visual acuity and macular thickness using ocular coherence tomography.

“In January we completed our phase I study of ATG3 in healthy volunteers and found excellent ocular safety following eye drop administration,” said Henry Hsu, chief medical officer of CoMentis.

“We are very pleased to begin this international phase II study as planned, and expect to have interim (six month) efficacy data by mid-2008. ATG3 could be the first topical angiogenic treatment for AMD and if approved, would compliment current therapies which require injection directly into the eye.”

ATG3 was evaluated in a phase I study. The primary endpoint was ocular and systemic safety and included detailed ocular slit lamp examination. In addition to demonstrating excellent ocular tolerability, the study confirmed that systemic exposure following eye drop administration is minimal, resulting in no systemic side effects.