Kato Pharmaceuticals Receives FDA IND Approval for Resolv ER™ in Vitreomacular Adhesion

Laguna Hills, California, February 17, 2022 /PRNewswire/ -- Kato Pharmaceuticals, a private clinical-stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved the company's application for the use ofResolv ER™Treatment of Vitreomacular Adhesion (VMA) and the submission of an Investigational New Drug (IND) application for human research. This leading-class patented formulation therapeutic is designed to separate the vitreous from the retina, thereby blocking the risk of progression of many retinal diseases. With this approval, Kato Pharmaceuticals LLC can proceed to study the efficacy of Resolv ER™ in treating vitreomacular adhesion. Vitreomacular adhesion may lead to retinal tears, retinal detachment, and macular holes.

Kato will conduct a multicenter, randomized, double-blind, sham-controlled study to evaluate the safety and efficacy of single and repeated intravitreal administrations. This study will enroll 100 patients. The objective of the study is to assess the safety of Resolv ER™ intravitreal administration in treating vitreomacular adhesion and restoring the retina to its normal state. The goal of the therapy is to maintain, improve, or restore vision. Resolv ER™ is administered via intravitreal injection of a liposome-encapsulated urea compound.

"As an expert in the field of retinal research, Dr. Arshad M. Khanani, who holds a medical degree and a master's in literature and is the principal investigator of this study, stated: 'We are continuing to seek safe and effective non-surgical options for treating vitreomacular adhesion. The design of Resolv ER™ involves injecting medication internally to induce detachment between the macula and the vitreous, showing potential to assist in treating patients with vitreomacular adhesion. I look forward to participating in this important clinical trial.'"

Kato Pharmaceuticals CEO Terrance McGovern stated, "We firmly believe that, based on follow-up related to the relevant indications, Resolv ER™ has the potential to ultimately help 5 to 6 million adults in the United States. Many retinal diseases currently have no cure, and existing therapies often only provide temporary relief, while the progression of these conditions will worsen with the patient's age and pathological advancement. The preliminary study results for Resolv ER™ are very encouraging, and we also hope that new trials will validate our early findings."

Patient recruitment will commence soon, with the study expected to roll out in the third quarter of 2022. The clinical research will be conducted across 15 core research centers and 10 backup research centers throughout the United States. The recruitment period is anticipated to last three to six months, followed by a three-month treatment period and a six-month follow-up period.

This study will quantify the percentage of subjects who achieve resolution of vitreomacular adhesion as determined by wide-field optical coherence tomography after single or repeated treatments, while also quantifying the incidence and severity of adverse events as determined by ophthalmic examination, intraocular pressure, and best-corrected visual acuity.