Australia's Circadian gets FDA nod for PhI on AMD candidate

Australia's Circadian Technologies won Investigational New Drug approval from the U.S. FDA for Phase I clinical trials of OPT-302 for patients with wet age-related macular degeneration (AMD), the company said on Monday. The candidate blocks the activity of certain proteins. The trial is a sequential dose-escalation study treating patients with wet AMD on a monthly basis for three months by ocular injection either alone or in combination with ranibizumab (Lucentis). "We are aggressively pursuing the development of this molecule following the compelling preclinical activity we have observed. Importantly, OPT-302 shuts down two proteins that are implicated in resistance to existing therapies," CEO and Managing Director Megan Baldwin said in a news release. Release (PDF)