Prior Clinical Studies

• Prior sponsor studied treatment with low concentration  API for Diabetic Retinopathy with total PVD endpoint diagnosed by OCT and B scan Ultrasound.
• Phase II/III in US, India, Mexico, 176 patients treated with no drug-related SAEs.
• First of two-Phase III prospective trials began enrollment; treatment with up to 4 monthly injections.
• Study was discontinued in 2010 post interim analysis due to uncertain regulatory path amid financial crisis.
• Interim analysis of 75 patients demonstrated efficacy> 50% PVD in active arm (N=50) 6 months post last injection.

Kato ARM-001 Phase 1B

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.

1. The first trial of 20 patients was conducted in Armenia using a Ministry of Health approved clinical protocol.
2. The second 20 patient trial was an FDA-approved investigator-sponsored trial (IST) conducted by Dr. Jeffrey Heier and Dr. David Boyer.

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

• Multi center, open-label, safety and efficacy study of single and repeat intravitreal treatment with Resolv ER™
• Up to 26 treatment naïve subjects with mild to moderate non-proliferative diabetic retinopathy
• Dose escalation format – 3-5 subjects per dose
• Currently completing Group 2 with good safety profile
• Primary objectives: Percent of subjects achieving complete PVD as determined by wide view OCT and B-scan ultrasound. Confirm safety of tested dose levels via incidence and severity of AEs as determined by ophthalmic exam, IOP, and BCVA
• This study is to identify the optimal dose regimen for the planned US Phase 2

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).

• Multi-center, randomized, double-masked, sham controlled safety and efficacy study of single and repeat intravitreal treatment with Resolv ER™
• 100 treatment naïve subjects at 15 core sites plus 10 back-up sites with mild to moderate non-proliferative diabetic retinopathy
• 2:2:1 ratio of low dose, high dose, and sham control subjects
• 3 to 6-month enrollment, 3-month treatment, 6-month follow-up
• Primary objectives
• Percent of subjects achieving complete PVD after 1 – 3 treatments as determined by wide view OCT and B-scan ultrasound
• Incidence and severity of AEs as determined by ophthalmic exam, IOP, and BCVA

Please contact us for further information on this clinical trial.

‍