Delcath Systems Inc.’s (DCTH) drug-device combination product Hepzato Kit awaits the FDA word on August 14, 2023.Hepzato Kit is proposed for the treatment of patients with unresectable hepatic-dominant metastatic ocular melanoma. This is the company’s second attempt to secure FDA approval for Hepzato Kit.The U.S. regulatory agency had declined to approve Hepzato Kit in September 2013, requiring the company to perform additional trials to establish the safety and efficacy of the product. The Hepzato Kit is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects.Every year, around 5,000 to 6,200 individuals in the United States and Europe are diagnosed with ocular melanoma, and approximately 50% of these patients are said to develop metastatic disease.DCTH closed Friday’s (Jul.28, 2023) trading at $4.28, down 3.39%.