Opthea doses first patient in OPT-302 trial

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Opthea (ASX:OPT), a developer of biologic therapies for the treatment of eye diseases, has announced the dosing of the first patient in its Phase 2b trial of OPT-302 for wet AMD.

The study is a randomised, controlled clinical trial of OPT-302, a novel VEGF-C/D ‘Trap’ therapy, in combination with Novartis' LUCENTIS (ranibizumab) for wet age-related macular degeneration (wet AMD).

“The dosing of the first patient in this Phase 2b trial is clearly an important milestone for OPT-302’s development, and we are delighted to clinically advance this novel VEGF-C/D inhibitor therapy which may offer patients improved outcomes when administered in combination with existing anti-VEGF-A agents,” said Dr Megan Baldwin, CEO and managing director of Opthea. 

The company said it plans to enrol 351 patients at sites in the US, Europe and Israel. Patients will be randomised in a 1:1:1 ratio to each of three treatment groups to investigate the clinical efficacy and safety of OPT-302 administered at 0.5mg or 2.0 mg in combination with LUCENTIS (0.5 mg) compared to LUCENTIS (0.5 mg) alone. Patients randomised to the LUCENTIS alone group will also receive a sham injection to mask the patient to the treatment group. Treatments will be administered on a monthly basis for 6 months via intravitreal injection.

The trial will be conducted in patients with wet AMD who have not received prior therapy.

The study's primary endpoint is the mean change in best corrected visual acuity (BCVA) from baseline to week 24. A number of secondary endpoints will also be evaluated, including investigation of OPT-302 on anatomical parameters of the wet AMD lesion using imaging techniques such as optical coherence tomography and fluorescein angiography. 

“We are pleased to have a number of clinical sites in the US now actively recruiting patients for this Phase 2b study and look forward to commencing recruitment in Europe and Israel in the coming months. All of the trial investigators and site staff are highly experienced in ophthalmic clinical trials and are excited to commence the clinical evaluation of OPT-302 in this randomised, controlled study,” said Clare Price, director of Clinical Development for Opthea.