VVN539 meets primary study endpoints in US phase IIa clinical study

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VivaVision Biotech Ltd. announced its ophthalmic solution, VVN539, has met primary endpoints in its Phase 2 clinical study.

The company announced in a press release the study was a double-masked, randomized, vehicle-controlled, dose-response study to assess the safety and ocular hypotensive efficacy of VVN539 in subjects with primary open-angle glaucoma or ocular hypertension.

The primary objective of the Phase 2 trial was to evaluate the ocular hypotensive efficacy of 2 concentrations of VVN539 at 0.04% and 0.02% in patients with primary open-angle glaucoma or ocular hypertension. While the secondary objective was to evaluate the ocular and systemic safety of VVN539 according to the release from the company.

VivaVision stated that ocular dosing with VVN539 resulted in a “clinically and statistically significant decrease in elevated intraocular pressure (IOP) in subjects with primary open-angle glaucoma and ocular hypertension.”

Furthermore, the company stated the 0.04% concentration of VVN539 was “statistically superior” to its vehicle at all 9 diurnal time points over the course of the study which lasted 21 days. The magnitude of the decrease from unmedicated baseline was 5 to 6 mm Hg."

The 0.02% concentration provided “statistically significant decreases from unmedicated baseline relative to its vehicle at majority of time points.”

The company concluded VVN539 Ophthalmic Solution “exhibited statistically and clinically significant ocular hypotensive activity and was well tolerated for the treatment of patients with primary open-angle glaucoma and ocular hypertension.”

VivaVision says that “further clinical studies of the drug will explore the therapeutic potential in comparison with a first-line hypotensive drug in a larger patient population.”