IVIEW Therapeutics Announces FDA Orphan Drug Designation for IVIEW-1201 in Fungal Keratitis

▎WuXi AppTec Content Team Report

April 8,iView Therapeutics (IVIEW Therapeutics）Announced that the U.S. FDA has granted its developedIVIEW-1201 (1.0% Povidone-Iodine Ophthalmic Gel Sterile Solution)Orphan Drug Designation, for the treatment ofFungal Keratitis (FK)iView Therapeutics' press release stated that this designation marks an important step for the company in addressing unmet medical needs in rare ophthalmic diseases.Provides a possible innovative solution for the treatment of patients with fungal keratitis.

Fungal keratitis is a severe ocular disease caused by infection of the cornea with filamentous fungi or yeast, posing a significant threat to eye health due to its high likelihood of causing vision loss or even blindness. Currently, Natamycin (NATACYN®) is the only FDA-approved treatment for FK, but there remains an urgent need for more effective therapeutic options.

Professor Ting Wang from the Ophthalmology Hospital of Shandong First Medical University, the leading investigator of the Phase 2 clinical trial of IVIEW-1201 for bacterial conjunctivitis in China, provided the following comments:IVIEW-1201, in principle, exhibits the advantage of rapidly eliminating various pathogens—including fungi, bacteria, and viruses—through a unique bactericidal mechanism and innovative drug delivery route, without easily inducing drug resistance. It features long-lasting sustained release and high safety.FDA Grants Orphan Drug Designation to This Medication"The recognition is based on the acknowledgment of its innovative science and targeted treatment principles, marking a key milestone in the further development of treatments for fungal keratitis. We look forward to advancing into clinical trials in this important field."

Dr. Bo Liang, Founder, Chairman, and CEO of iVIEW Therapeutics, Inc., stated: "The FDA's orphan drug designation for IVIEW-1201 in treating fungal keratitis is a recognition of our scientific innovation capabilities. Patients with FK have long faced the challenge of limited treatment options, and IVIEW-1201 is expected to become a differentiated therapy. We look forward to accelerating its clinical development to provide patients with safer and more effective solutions."

iView Therapeutics Initiates Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of IVIEW-1201 versus NATACYN® in FK Patients. The trial will focus on key indicators such as corneal lesion regression rate, fungal clearance rate, and vision improvement.

References:

[1]iVIEW Therapeutics, Inc. Announces FDA Orphan Drug Designation for IVIEW-1201 for the Treatment of Fungal KeratitisRetrieved Apr 8，2025, From https://mp.weixin.qq.com/s/4rlw4AYL-MR6pJ_tWRuN3g