The Opthea Ltd (ASX: OPT) share price will return from its trading halt this morning and could surge higher following the release of a very positive announcement by the developer of novel biologic therapies for the treatment of eye diseases.
What did Opthea announce?
This morning Opthea announced positive Phase 2b results for its OPT-302 combination therapy.
According to the release, the combination therapy met the primary endpoint of superiority in mean visual acuity gain at 24 weeks compared to the Lucentis monotherapy in treatment-naïve patients with wet age-related macular degeneration (AMD).
Professor Tim Jackson, Chief Investigator of the study, explained: "In testing for superiority against very intensive anti-VEGF-A therapy, the bar was set high. Despite this, OPT-302 (2.0 mg) combination therapy showed statistical superiority for the most accepted and sensitive primary efficacy outcome – mean visual acuity."
The release explains that the Phase 2b, randomised, double-masked, sham-controlled clinical trial recruited 366 wet AMD patients who were allocated to two intravitreal doses of OPT-302 (0.5 mg and 2.0 mg), administered monthly in combination with 0.5 mg Lucentis over 24 weeks, versus a control group that received standard of care 0.5 mg Lucentis administered monthly.
Patients administered 2.0 mg of OPT-302 combination therapy gained a mean of 14.2 letters of vision from baseline on the Early Treatment of Diabetic Retinopathy Study (ETDRS) standardised eye chart at 24 weeks.
This compares to 10.8 letters in the control group, which is a statistically significant benefit of 3.4 letters. The 0.5 mg OPT-302 low dose group had a similar outcome to the control group (+9.4 letters).
Furthermore, compared to Lucentis monotherapy, OPT-302 (2.0 mg) combination treatment showed improvements across multiple secondary endpoints, including a higher proportion of patients with stable vision.
Another positive was that OPT-302 intravitreal injections were well tolerated, with the safety profile similar to the control group. The independent Data and Safety Monitoring Board confirmed that no safety risks were identified.
The company's CEO and Managing Director, Dr Megan Baldwin, was very pleased with the study results.
She said: "We are extremely pleased with the significant positive outcomes from this study. They further support our conviction that OPT-302, the first 'Trap' inhibitor of vascular endothelial growth factors C and D designed specifically for the eye, can improve patient outcomes in wet AMD and other retinal vascular diseases."
Looking ahead, Dr Baldwin advised: "Additional analyses of the Phase 2b study are ongoing, and we look forward to presenting detailed data at future ophthalmology conferences, as well as reporting topline data from our ongoing Phase 2a clinical trial of OPT-302 in patients with persistent diabetic macular edema, anticipated in early 2020."
Also on watch today will be the Althea Group Holdings Ltd (ASX: AGH) share price after the cannabis company provided an update on patient numbers and of course Commonwealth Bank of Australia (ASX: CBA) after its full year results release.
