Prior Clinical Studies
For Treatment of Vitreomacular Attachment with Traction VMT Kato Pharmaceuticals conducted two separate trials from 2012 to 2014, assessing the effects of Resolvine, on the resolution of VMT in a total of 40 subjects.
In both studies, patients were carefully monitored at several time points following the intravitreal injection of 100 microliters of Resolvine and no immediate or delayed toxicity was noted up to 180 days post-injection.
Follow-up data on the patients receiving 9% Resolvine showed success in 14% (1 of 7) and the 18% group showed success in 44% of the patients (7 of 16). The 36% group showed 46% success (6 of 13). These clinical data further support the safety and efficacy of the formulation for intravitreal injection in human subjects.
Following the completion of these studies, Kato Pharmaceutical’s Resolvine for ophthalmic intravitreal injection was re-formulated to achieve extended release. The new-formulation formulation allows a direct delivery of the Resolv ER™ drug to the target area of the retina.
Kato Phase Mex-101 Phase 1B/2A
Planned Kato US Phase 2 Safety and Efficacy Study
In 2022, Kato Pharmaceuticals will be conducting a 100 patient Phase 2 FDA Supported multi-center, randomized, double-masked, sham controlled safety and efficacy study of single and repeat intravitreal treatment with Resolv ER™. The objective is to assess the safety of intravitreal administration of Resolv ER™ and the capability of the treatment to produce a complete posterior vitreous detachment (PVD) in patients with mild to moderate non-proliferative diabetic retinopathy (NPDR).
Please contact us for further information on this clinical trial.