Resolv ER™

There is no cure for diabetic retinopathy (DR) and current treatments, such as anti-VEGF injections for chronic treatment for diabetic macular edema (DME) and DR and panretinal laser therapy, provide only temporary relief. Kato Pharmaceuticals is developing a first-in-its-class treatment for DR using urea as the active pharmaceutical ingredient (API) for intravitreal injection. Urea acts to disrupt the hydrogen bonds between the vitreous and the retina, inducing a total posterior vitreous detachment (PVD) that may slow the progression of retinal damage due to DR and other age-related pathologies of the eye. By using this therapeutic, patients suffering from these pathologies can avoid invasive surgery and preserve vision.

Because the volume of drug that can be delivered to the eye is limited by the size of the organ, and because ophthalmic formulations dissipate relatively quickly once introduced into the vitreous, delivering and maintaining therapeutic doses of drugs to the macula and adjacent tissues has been a great challenge for ophthalmic drug developers and clinicians. There exists a need for ophthalmic drug formulations that can deliver a therapeutically effective dose to the back of the eye over an extended period of time for the treatment of chronic diseases, such as AMD, DME, and DR, among others.

Liposomes represent a promising injectable delivery system for intravitreal administration AS they are a biodegradable, biocompatible carrier that can provide sustained release for prolonged periods. By controlling their size and structure, one can tailor the intravitreal elimination kinetics of the liposome carrier and the encapsulated API. This will optimize liposome formulations to be used in delivering a sustained release of urea to the vitreoretinal interface to cause a total PVD within the clinically acceptable duration of less than 30 days.

Resolv ER™ is an intravitreal injection of liposome loaded urea compound for the inducement of a total PVD in subjects with Nonproliferative Diabetic Retinopathy (NPDR). Kato Pharmaceuticals will initiate Resolv ER in a Phase 2 safety and efficacy study in the United States.

Liposome product coating the Retina

(Images are from preclinical studies with New Zealand White Rabbits)