Combining Opthea Ltd.'s OPT-302 therapy with Roche Holding AG and Novartis AG's Lucentis was found to be more effective in treating symptoms of a chronic eye disorder than Lucentis alone in a mid-stage study.
The company's phase 2b study evaluated a combination of OPT-302 and Lucentis, or ranibizumab, against Lucentis as monotherapy in 366 patients with wet age-related macular degeneration, or AMD.
Wet AMD is caused by abnormal blood vessels that leak fluid or blood into a part of the eye called the macula, causing blurred vision and rapid and severe vision loss.
At week 24 of the study, patients dosed with 2.0 milligrams of OPT-302 in combination with 0.5 milligrams of Lucentis gained significant clarity in vision compared to patients who were given 0.5 milligrams of Lucentis every four weeks.
Meanwhile, patients in the low dose group who received 0.5 milligrams of OPT-302 in combination with 0.5 milligrams of Lucentis had similar results to the group that received Lucentis as monotherapy.
Compared to Lucentis, the higher dose of combination therapy also showed improvements across multiple secondary endpoints, including a higher proportion of patients with stable vision and visual clarity.
Opthea, which released the results of the phase 2b trial six months ahead of schedule, said the data support advancing OPT-302 into phase 3 development.
The Australian company is undertaking additional analyses of the data from the study, which will be presented at upcoming ophthalmology conferences.
In addition, Opthea plans to report topline data from its ongoing phase 2a study of OPT-302 in patients with persistent diabetic macular edema, an eye disease that could potentially lead to severe vision loss, in early 2020.
Opthea has enough funding for the phase 2b trial close-out activities and the end of the study in diabetic macular edema, as well as the preparation for phase 3 trial activities.