This was a Phase 2, 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.
SHANGHAI, June 4, 2023 /PRNewswire/ -- This was a Phase 2, 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 (POAG) or ocular hypertension (OHT). The primary objective was to evaluate the ocular hypotensive efficacy of 2 concentrations of VVN539 Ophthalmic Solution (0.04% and 0.02%) in patients with POAG or OHT, and the secondary objective was to evaluate the ocular and systemic safety of VVN539 Ophthalmic Solution.
In this double-masked, vehicle and dose-controlled, and parallel first in human study, topical ocular dosing with VVN539 Ophthalmic Solution resulted in a clinically and statistically significant decrease in elevated intraocular pressure (IOP) in subjects with OHT and POAG. The 0.04% VVN539 Ophthalmic Solution was statistically superior to its vehicle at all 9 diurnal time points over the course of the 21 days study. The magnitude of the decrease from unmedicated baseline was 5 to 6 mm Hg. The 0.02% VVN539 Ophthalmic Solution provided statistically significant decreases from unmedicated baseline relative to its vehicle at majority of time points. Consistent with other studies of this type, there was a 1-2 mm Hg reduction in IOP seen in the vehicle group. The results of this Phase 2 study indicate that VVN539 appears safe and well tolerated in adult subjects with POAG or OH.
Overall, 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. Further clinical studies of the drug will explore the therapeutic potential in comparison with a first-line hypotensive drug in a lager patient population.
About VVN539
VVN539 is a first-in-class, duo MOA small molecule for the treatment of glaucoma. It acts directly at trabecular meshwork, increases the outflow of aqueous humor, and thus lowers intraocular pressure (IOP). In a preclinical animal model, VVN539 exhibited remarkable IOP lowering efficacy, and this innovative drug is expected to be competitive in the global glaucoma market.
About Vivavision Biotech Ltd.
VivaVision is a clinical stage pharmaceutical company focused on best-in-class and first-in-class therapies for ocular diseases. Besides VVN001 program, VivaVision is developing VVN539 for the treatment for Glaucoma or Ocular Hypertension, and VVN461 for the treatment of non-infectious ocular inflammation of Uveitis. Vivavision is also engaged in discovery and development of novel therapies for the treatment of other anterior and posterior eye diseases.
VivaVision is led by experienced drug hunters in the fields of ophthalmology. The company is inspired to be a global leader of ophthalmic drug discovery. VivaVision is backed by leading life sciences investors including Sequoia, Lapam, Cenova. CTJA, etc.
To learn more about VivaVision, Visit: www.vivavisionbio.com
Media Contact: support@vivavisionbio.com
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SOURCE VIVAVISION BIOTECH LTD
