For Treatment of Vitreomacular 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. The first trial of 20 patients was conducted in Armenia using a Ministry of Health approved clinical protocol. 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 9% (1 of 7) and the 18% group showed success in 44% of the patients (7 of 16). The 36% group showed 38% 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.
The clinical hypothesis is that Resolv ER® at the tested concentrations is:
- safe and well-tolerated with single and repeat intravitreal administration of 100 µL in patients with mild to moderate non-proliferative diabetic retinopathy, as assessed by the incidence of adverse events
- more effective than sham treatment in producing a complete PVD, as assessed with wide-field spectral domain optical coherence tomography (WF sd OCT)