An innovative Melbourne biotech company has overcome a major hurdle in the development of a new drug for the treatment of widespread, age related eye disease.
Opthea Limited has met safety and tolerance requirements in dosage levels for its first-in-human clinical trial of OPT-302, a novel therapy for wet age-related macular degeneration (wet AMD).
Wet AMD, is a leading cause of blindness in the western world for people, typically, over the age of 50.
It is a disease that causes vision loss in the middle of the visual field triggered by the deterioration of the macula – the central portion of the retina. This degeneration is caused by abnormal blood vessel growth and fluid and protein leaks from the vessels.
OPT-302 blocks the activity of two proteins that cause blood vessels to grow and leak.
The trial is investigating OPT-302 administered by ocular injection once a month for three months, either alone or with another drug called Lucentis®.
The study is being run through America's Food and Drug Administration (FDA) at 14 sites across the U.S. The 28 day safety assessment period has been completed for all 20 patients in the first phase of the trial.
The trial found any adverse effects to be mild and manageable and mainly related to the injection procedure. There were no signs of endophthalmitis or infection inside the eye.
There were also no significant changes in intraocular pressure, electrocardiograms, blood pressure or other vital signs during the safety assessment period at all dose levels.
Thirty additional wet AMD patients will now be recruited for Phase 2A of the study. Patients will be divided into two groups, one injected with OPT-302 as a monotherapy and another given the drug in concert with Lucentis. The second trial will again be on a monthly basis for three months.