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- Opthea Limited has presented results from its recently completed Phase 2b study in eye disease in San Francisco
- These test results were presented for the first time in the U.S. by Dr Megan Baldwin, Opthea’s CEO
- Opthea’s product helps people who are suffering vision loss and blurry vision and treats patients are suffering wet age-related macular degeneration (AMD) and whose vision suffers because of it.
- Opthea shares are down 4.35 per cent with shares trading for $3.30 each
Opthea Limited has presented the results of its recently completed Phase 2b study of OPT-302 at the Ophthalmology Innovation Summit in San Fransisco.
The Phase 2b study outcomes were presented for the first time in the U.S. by Dr Megan Baldwin, Opthea’s CEO.
OPT-302 is a soluble form of vascular endothelial growth factor receptor that blocks the activity of VEGF-C and VEGF-D proteins. These proteins cause blood vessels to grow and leak – a process which contributes to the onset of retinal diseases.
The product helps treat patients who are suffering wet age-related macular degeneration (AMD) and whose vision suffers because of it.
In Australia, AMD currently affects roughly 1.25 million people and a further eight million are at risk. It affects the macular region of the retina which is used for seeing straight ahead.
Those suffering AMD can see clearly to the sides but looking straight ahead will be a blur. This primarily affects activities such as reading, writing, colour vision, and looking at detailed objects.
New clinical data included pre-specified subgroup and exploratory analyses showing the additive benefit of OPT-302 combination therapy in patients with Wet AMD lesions.
This additional data supports the recent reporting of superiority of OPT-302 combination therapy.
“Achieving the primary endpoint of superior visual acuity gains in the Phase 2b Wet AMD study has highlighted the commercial potential of OPT-302 in combination therapy,” Dr Megan said.
“These pre-specified subgroups and exploratory data analyses not only provide insight into which patients may be more likely to respond but also suggest improved benefit of OPT-302 combination therapy over anti-VEGF-A standard of care,” she added.
The Phase 2b trail administration allowed for the randomisation of patients with a broad range of lesion morphology.
To assess the effects of OPT-302 combination therapy compared to ranibizumab (an anti-angiogenic that has been approved to treat wet AMD) treatment in patients with different choroidal neovascularisation lesion types.
Results revealed that OPT-302 combination therapy supported improved visual activity with great reductions in retinal thickness, retinal fluid and total lesion area at week 24 compared to the control group.
This data follows on from the recent reporting of the primary outcome of the study which demonstrated that patients who were administered 2.0mg of OPT-302 combination therapy gained a mean of 14.2 letters of vision at 24 weeks.
This is compared to the 10.8 letter improvement in the sham + ranibizumab control group.
OPT-302 injections were also well tolerated with the safety profile similar to the control group.
Opthea is now continuing to review the Phase 2b study data with its advisory group of leading retail specialist opinion leaders to advance OPT-302 clinical development plants.
Despite these results, Opthea is down 4.35 per cent with shares trading for $3.30 each.
