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Australian ophthalmic biotech begins European trials

04/04/2018By Matthew Woodley • Staff Journalist
Australian biotech company Opthea has dosed the first European patients in the Phase 2b trial of its neovascular age-related macular degeneration (AMD) therapy, OPT-302.

The trial will enrol 351 patients who have not received prior therapy, and is designed to investigate whether the addition of its VEGF-C/D inhibitor, OPT-302, to Lucentis therapy over a six-month dosing period will improve visual acuity and anatomical parameters of neovascular AMD lesions.


“The activation of clinical trial sites in Europe and Israel represents significant progress in our Phase 2b trial. It expands patient recruitment for the study into another nine countries and follows a successful investigators meeting in Barcelona.”
Megan Baldwin, Opthea CEO

The US portion of the ‘Trap’ therapy trial began in December and has already enrolled patients from more than 50 clinical sites, while the company is reported to be on track to open six trial sites in Israel and more than 50 across eight European countries.

According to CEO and managing director Dr Megan Baldwin, all of the countries and sites have been selected based on experience with conducting ophthalmic clinical trials with anti-VEGF-A therapies.

“The activation of clinical trial sites in Europe and Israel represents significant progress in our Phase 2b trial. It expands patient recruitment for the study into another nine countries and follows a successful investigators meeting in Barcelona,” she said.

Last year, the ASX-listed company released positive results from its Phase 1/2a clinical trial of OPT-302, which demonstrated a strong safety profile and suggested the combination therapy was more effective in treating neovascular AMD than current methods. Primary analysis of data from the Phase2b trial is anticipated in early 2020.

Image courtesy: Freepik

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