Opthea soars on positive results for Lucentis combination

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Opthea (ASX:OPT), an Australian clinical-stage biopharmaceutical company developing novel biologic therapies to treat eye diseases, has reported positive results from its Phase 2b trial of OPT-302 for wet age-related macular degeneration (AMD).

The company had entered a trading halt ahead of the highly-anticipated update - its share price soared over 140 per cent in response to the news.

The clinical trial is evaluating the safety and efficacy of Opthea's OPT-302 in combination with Novartis' PBS-listed LUCENTIS (ranibizumab) for wet AMD.

OPT-302 is a soluble form of vascular endothelial growth factor receptor 3 (VEGFR-3) or ‘Trap’ molecule that blocks the activity of two proteins (VEGF-C and VEGF-D) that cause blood vessels to grow and leak - processes which contribute to the pathophysiology of retinal diseases.

In the trial, 366 wet AMD patients 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.

According to the company, patients administered the OPT-302 (2.0mg)-LUCENTIS combination gained a mean of 14.2 letters of vision from baseline on the Early Treatment of Diabetic Retinopathy Study (ETDRS) standardized eye chart at 24 weeks, compared to 10.8 letters in the LUCENTIS control group.

"The 0.5 mg OPT-302 low dose group had a similar outcome to the control group (+9.4 letters)," said the company.

"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 (defined as ≤ 15 letter loss from baseline), and those gaining ≥10 and ≥15 letters of visual acuity."

“OPT-302 has the potential to be a game-changer in the treatment landscape, not just for wet AMD but also for other debilitating retinal vascular diseases where there remains a significant unmet medical need for more efficacious therapies," said Dr Pravin Dugel, managing partner of Retinal Consultants of Arizona and clinical professor at the University of Southern California Roski Eye Institute, Keck School of Medicine, and study investigator on the trial.

"The Phase 2b trial results demonstrate for the first time, that clinically meaningful gains in visual acuity approaching 3 lines of vision (15 letters) may be possible with OPT-302 combination therapy targeting a novel mechanism of action.” 

Opthea said it is in a "strong cash position" with around $20 million cash and an additional $14 million from an anticipated Research and Development tax rebate later this year. It also said the trial has reported six months ahead of schedule "leading to substantial cost savings".

"Opthea is fully funded through the remaining Phase 2b trial close-out activities and completion of the ongoing Phase 2a study in diabetic macular edema. In addition, the Company has sufficient capital to prepare for registrational Phase 3 trial activities and evaluation of all strategic and corporate options," added the company.