Australian company Circadian Technologies Limited has commenced its Phase 1 study of OPT-302 in patients with wet age-related macular degeneration at five clinical trial sites in the US. The trial is under an investigational new drug (IND) authorisation received from the US Food and Drug Administration (FDA) mid-June.
The first-in-human multi-centre dose-escalation clinical trial will investigate OPT-302 administered either alone or in combination with ranibizumab (LucentisTM) on a monthly basis for three months by ocular injection. The trial will be conducted in wet age related macular degeneration patients who have either not been treated previously (treatment naïve patients) or who have demonstrated a sub-optimal response to prior anti-VEGF-A therapy. Endpoints of the study include assessment of the safety of OPT-302 and preliminary measures of clinical efficacy, including evaluation of visual acuity using eye charts as well as changes in wet AMD lesions using optical coherence tomography and fluorescein angiography.
Analysis of data from the dose escalation cohorts in the clinical trial is anticipated in the first quarter of 2016.
Following IRB approval in the US for the Phase 1 study and the clinical investigators conducting the trial, the
five sites have begun recruitment activities for patient screening and enrolment. The trial sites are strategically spread throughout North America in geographic regions of large patient populations with retinal diseases including wet age related macular degeneration. According to Circadian Technologies CEO Dr. Meg Baldwin, the clinical investigators and site staff are highly experienced in ophthalmic clinical trials and provided key contributions to the clinical development of marketed wet age related macular degeneration therapies including Lucentis and Eylea.
OPT-302 blocks VEGF-C and VEGF-D, which cause blood vessels to grow and leak. In preclinical models of wet age related macular degeneration OPT-302 demonstrates significant activity as a monotherapy and additive activity when used in combination with existing agents that block VEGF-A.
The trial is being conducted via Circadian’s wholly owned subsidiary Opthea Pty. Ltd.
