Opthea Reports Positive Data From Wet AMD Clinical Trial

MELBOURNE, AUSTRALIA--(Marketwired - Jul 25, 2016) - Opthea Limited (ASX: OPT)

• Phase 1 dose escalation study met primary objective demonstrating OPT-302 safety and tolerability as monotherapy and in combination with standard of care Lucentis^®
  
  
• Changes in visual acuity (VA) and anatomic improvements on SD-OCT following the 3 month multiple dosing period demonstrate clinical activity of OPT-302 in both treatment naïve patients and prior treated patients
  
  
• Encouraging results suggest that combined inhibition of VEGF-C/D and VEGF-A may lead to improved outcomes over Lucentis^® alone
  
  
• Results represent an important milestone for Opthea
  
  
• Opthea is actively accruing patients into Phase 2A dose expansion cohorts and planning for initiation of a randomised controlled Phase 2B clinical study in wet AMD patients in 2017
  
  

Opthea Limited (ASX: OPT), a developer of novel biologic therapies for the treatment of eye diseases, today announced positive data from its ongoing first-in-human clinical trial of OPT-302, a novel VEGF-C/D 'Trap' therapy for wet age-related macular degeneration (wet AMD). The Company will host a conference call and webcast at 10:30am Australian Eastern Daylight Time (8:30pm US EDT) today.

To access the live webcast, please visit the Presentations page of the Opthea website at http://www.opthea.com/presentations/. Alternatively, you may access the live conference call by dialling [phone] (U.S.) or [phone] (Australia) or [phone] (international) and using conference ID 4334252. An audio archive of the webcast will be available following the call at http://www.opthea.com/presentations/.

The study is being run under an Investigational New Drug (IND) program with the Food and Drug Administration (FDA) at 14 sites across the U.S. (ClinTrials.gov ID#: NCT02543229). The first-in-human trial of OPT-302 comprises two parts: a sequential dose escalation (Phase 1, 20 patients) and a randomised dose expansion study (Phase 2A, up to ~30 patients) in patients that have either not been treated previously (treatment naïve patients) or who have demonstrated a sub-optimal response to prior anti-VEGF-A therapy.