- Opthea (OPT) has treated the first patient in its phase three clinical program of its OPT-302 treatment against wet age-related macular degeneration (AMD)
- Wet AMD is a form of macular degeneration, which causes sight-loss in the due to leavy blood vessels growing under the retina
- The company is currently conducting two concurrent global phase three trials, nicknamed ShORe and COAST, and has enrolled around 990 treatment-naive patients each
- The goal of both studies is to identify the average change in best corrected visual acuity for OPT-302 combination therapy compared to commonly used treatments alone
- The company expects to report on the data by 2023 and intends to submit Biologics License and Marketing Authorisation Applications with the FDA and EMA
- Opthea is up 3.36 per cent, trading at $1.54 per share
Opthea (OPT) has treated the first patient in a phase three clinical program of its OPT-302 treatment against wet age-related macular degeneration (AMD).
Opthea is a clinical stage biopharmaceutical company developing a novel therapy to treat progressive retinal diseases. Macular degeneration causes loss in the centre of the field of vision. Opthea’s program is focussed on wet AMD, which occurs when leaky blood vessels grow under the retina.
The first treatment of the company’s VEGF-C/D “trap” inhibitor, OPT-302, took place in Maryland, USA.
“Dosing the first patient in our OPT-302 Phase 3 pivotal clinical program in wet AMD marks a very important achievement for Opthea in accelerating the development of this novel VEGF-C/D inhibitor therapy towards market registration” said CEO of Opthea Dr Megan Baldwin.
“We are now looking forward to quickly ramping up enrolment to meet the interest from participating clinical sites and retinal specialists. OPT-302, which has shown promising efficacy and favourable safety profiles in trials to date, is an important new treatment option which may offer patients improved outcomes when administered in combination with VEGF-A inhibitors.”
The company is currently conducting two concurrent global phase three trials, which have been nicknamed ShORe and COAST.
Both studies will enrol around 990 patients each who have not had any previous treatment, to assess the efficacy and safety of OPT-302 in combination with commonly used treatments ranibizumab and aflibercep.
The goal of the ShORe and COAST studies is to identify the average change in best corrected visual acuity for OPT-302 combination therapy compared to the commonly used treatments alone.
Each patient will also continue to be treated for a further year to evaluate extended safety and tolerability over a two-year period.
A number of secondary endpoints will also be evaluated, such as visual function, anatomical changes in the wet AMD lesions and fluorescein angiography imaging.
The initiation of the phase three pivotal clinical program follows the reporting of positive outcomes from the phase 2b clinical trial of OPT-302 in 366 patients with wet AMD.
The company says it expects to report on the data by 2023 and intends to submit Biologics License and Marketing Authorisation Applications with the FDA and EMA following completion of the 12-month primary efficacy phase of the trials.
Opthea is up 3.36 per cent, trading at $1.54 per share at 9:40 am AEDT.