Biopharmaceutical company Opthea (ASX: OPT) has started a Phase 1b/2a trial investigating the effectiveness of its OPT-302 drug in diabetic eye diseases.
Diabetic macular edema leads to the thickening of the retina caused by leaky blood vessels. The disease is the leading cause of blindness in diabetes and affects more than two million people around the world.
According to Opthea, existing treatments usually involve steroids, laser therapy or VEGF-A inhibitors. However, these treatments, alone, can have minimal impact with many patients plagued by ongoing impaired vision.
Opthea’s OPT-302 drug blocks the activity of the VEGF-C and VEGF-D proteins which cause blood vessels to grow and leak, which contribute to macular edema.
Following recent Food and Drug Administration and central Institutional Review Board approvals, Opthea has begun recruiting people in the United States to take part in the phase 1b/2a trial for its OPT-302 drug.
When OPT-302 is combined with a VEGF-A inhibitor, the company believes clinical outcomes can be improved in diabetic macular edema sufferers.
“We are delighted to advance and expand the clinical research program of OPT-302 into diabetic macular edema,” Opthea chief executive officer and managing director Dr Megan Baldwin said.
Dr Baldwin added the study will enable the company to more broadly understand OPT-302’s potential.
The trial comprising about 117 people will be carried out in the US and Australia. Opthea is recruiting people suffering from persistent diabetic macular edema despite treatment with anti-VEGF-A therapy.
Each patient will have specific doses of OPT-302 and VEGF-A inhibitor Eylea injected into affected eyes on a monthly basis for three months.
Patients will then be evaluated for efficacy and safety/tolerability of the treatment as well as monitored for secondary measures including any changes in diabetic retinopathy and macular volume.
Data from the trial is due by the end of June 2019.
In additional to investigating OPT-302 in diabetic macular edema, Opthea has undertaken trials of the drug in wet age-related macular degeneration, which is the world’s leading cause of blindness in people aged over 50.
Sales of two drugs that inhibit VEFG-A to treat these diseases amounted to almost US$9 billion in 2016.
Shares in Opthea were unchanged in early morning trade at A$0.70