Opthea reports positive trial results for OPT-302

Company News

Opthea (ASX:OPT), a developer of novel biologic therapies for the treatment of eye diseases, has announced what it describes as positive results from its Phase 1/2A clinical trial of OPT-302, a novel VEGF-C/D ‘Trap’ therapy for wet age-related macular degeneration (wet AMD).

The study has been conducted at 14 sites in the US and run under an Investigational New Drug (IND) program with the FDA.

"OPT-302 demonstrated clinical activity in all patient groups investigated, including naïve and prior- treated patients in both the monotherapy and combination OPT-302 + Lucentis groups," said the company. "Improvements in visual acuity (VA) and retinal swelling (central subfield thickness (CST) and sub- retinal fluid (SRF)) were observed suggesting additional clinical benefit with more complete suppression of VEGF-A and VEGF-C/D."

“We are excited by these promising results from the Phase 1/2A wet AMD clinical study with OPT- 302” said Dr Megan Baldwin, CEO of Opthea. “This data warrants Opthea expanding its clinical development program to progress OPT-302 as a novel combination therapy for the treatment of wet AMD as well as other eye diseases, including diabetic macular edema."

The Phase 1/2A study met its primary safety objective, with intravitreal injections of OPT-302 being well tolerated both as monotherapy and in combination with standard of care Lucentis. No treatment related serious adverse events, systemic adverse events or dose limiting toxicities were observed.

"Overall, 90% of patients (44/49) evaluable at week 12 maintained or improved VA at week 12, compared to baseline. Of the 49 patients, 100% had stabilization or improvement in visual acuity," said the company.

"In treatment naïve patients who received combination OPT-302 + Lucentis, the mean change in VA from baseline at week 12 was +10.8 letters (n=18). The visual acuity improvements were seen as early as four weeks and continued to increase throughout the study to week 12. In addition, 33 percent of these treatment naïve patients showed BCVA gains of ≥ 15 letters (≥ 3 lines) on a standard eye-chart at week 12.

"The mean change in VA from baseline at week 12 in previously treated patients with difficult to treat wet AMD was +4.9 letters (n=19 evaluable), despite long term prior treatment with anti-VEGF-A therapy (mean number of prior treatment injections = 17, range 3, 76)."