FDA approves IND application for human studies of therapeutic for retinal disorders

Kato Pharmaceuticals today announced that the FDA has approved the company's investigational new drug (IND) application to conduct human studies using Resolv ER for the treatment of vitreomacular attachment (VMA).

This formulation therapeutic drug is intended to separate the vitreous from the retina to reduce the risk of progression of many retinal pathologies. This approval allows Kato to study the efficacy of Resolv ER on VMA which may lead to retinal tears, retinal detachment, and macular holes.

According to the company, it will conduct a 100-patient, multi-center, randomly assigned, double-masked, sham-controlled safety and efficacy study of single and repeat intravitreal treatment. The objective of the study is to assess the safety of intravitreal administration of Resolv ER with the treatment capability to resolve the attachment and allow the retina to return to its normal position. The goal is preserving, improving, or restoring vision. Resolv ER is administered as an intravitreal injection of liposome-loaded urea compound.

According to the company, patient recruitment will be underway soon, with the study expected to begin during the third quarter of 2022. The company also noted in its news release that the upcoming clinical study will be conducted at 15 core sites, plus 10 backup sites, across the United States. There will be a 3- to 6-month enrollment period, 3-month treatment period and 6 months of follow-up.

The company also noted that the study will quantify the percentage of subjects achieving resolution of VMA after one or repeat treatments as determined by wide-view optical coherence tomography; and the incidence and severity of adverse events as determined by ophthalmic exam, intraocular pressure and best corrected visual acuity.

“We are continuing to look for safe and efficacious non-surgical options to treat vitreo-macular adhesion,” Arshad M.Khanani, MD, MA, the lead principal investigator for the study said in a statement in the company’s news release. “Resolv ER is designed to induce a vitreous detachment with an in-office injection and has the potential to help our patients with vitreo-macular adhesion. I am looking forward to being a part of this important clinical trial."

Terrance McGovern, CEO of Kato Pharmaceuticals, said in the news release that the company believes the therapeutic has the potential, with follow on indications, to ultimately help between 5 million and 6 million adults in the United States.

“There is no cure for many retinal disorders, and current treatments usually provide only temporary relief to these conditions, which progress as a patient ages and the pathology worsens,” McGovern said in the statement. “We're very encouraged by preliminary study results of Resolv ER and hope our new trial will validate our earlier findings."