Circadian receives IND approval from FDA to initiate clinical trial of OPT-302 for wet AMD patients

15-Jun-2015 - Australia

Circadian Technologies Limited through its wholly owned subsidiary Opthea Pty Ltd announced that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to initiate its Phase 1 clinical trial of OPT-302 in patients with wet age-related macular degeneration (wet AMD).

Circadian’s CEO and Managing Director Dr Megan Baldwin said “The FDA’s acceptance of our IND for the Phase 1 clinical trial of OPT-302 is a major milestone for the Company. It is the result of a detailed review by the FDA of our non-clinical data package including preclinical safety/toxicology, efficacy testing and manufacturing processes for OPT-302, as well our Phase 1 study design. We look forward to bringing this important novel therapy to wet AMD patients for whom there remains a significant unmet medical need.”

Opthea’s first-in-human multi-centre clinical trial is a sequential dose escalation study of OPT-302 administered to patients with wet AMD on a monthly basis for three months by ocular injection either alone or in combination with ranibizumab (Lucentis®). The primary endpoint of the study will be an assessment of the safety and tolerability of OPT-302. Secondary endpoints include the pharmacokinetic profile of OPT-302 as well as preliminary measures of clinical efficacy as measured by visual acuity (eye charts) and sophisticated imaging techniques to determine retinal thickness and wet AMD lesion area using optical coherence tomography (OCT) and fluorescein angiography.

https://www.bionity.com/en/news/153273/circadian-receives-ind-approval-from-fda-to-initiate-clinical-trial-of-opt-302-for-wet-amd-patients.html