Opthea (ASX:OPT), a clinical-stage biopharmaceutical company developing novel biologic therapies to treat eye diseases, has announced that the timing of the primary analysis from its ongoing Phase 2b trial of OPT-302 for wet age-related macular degeneration (AMD) will be brought forward by one quarter.
The company said the primary data is now expected to be reported in the third quarter of calendar year 2019.
“The reporting of top-line data from our randomised, controlled Phase 2b trial in 366 treatment naïve wet AMD patients represents a major clinical milestone for Opthea. Progress in the last few months has been excellent, such that we now expect to report primary data from this study several months earlier than originally anticipated,” said Dr Megan Baldwin, CEO and managing director of Opthea.
Opthea said it is also progressing its clinical program in diabetic macular edema.
"The ongoing Phase 2a randomised, controlled clinical trial evaluating the safety and efficacy of OPT-302 in patients with persistent center-involved diabetic macular edema (DME) is now well advanced with the study entering its final phase of recruitment. Primary data from the Phase 2a DME trial is expected to report early in 2020," it said.
“Whilst we remain masked to the clinical trial results of both Phase 2 studies, we are very much looking forward to reporting trial outcomes with our novel VEGF-C/D ‘trap’, OPT-302, which has the potential to address diseases for which there is significant unmet medical need and commercial opportunity,” continued Dr Baldwin.