IVIEW Therapeutics Inc. Announces FDA Grants Orphan Drug Designation to IVW-1201 for the Treatment of Fungal Keratitis

April 2, 2025 – Cranbury, New Jersey – IVIEW Therapeutics Inc., a clinical-stage biotechnology company focused on innovative ophthalmic treatments, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to IVIEW-1201 (1.0% povidone-iodine ophthalmic gel sterile solution) for the treatment of Fungal Keratitis (FK). The designation was granted on March 17, 2025 (Eastern Time), and marks a significant step forward in the company’s mission to address unmet medical needs in rare ophthalmic diseases.  Significance of the Orphan Drug Designation  The orphan drug designation for IVIEW-1201 in the treatment of fungal keratitis represents a major milestone for IVIEW Therapeutics in the field of ophthalmic health. It offers the potential to bring an innovative solution to patients suffering from FK, a serious and often overlooked eye condition.  Fungal Keratitis: A Serious Threat to Vision Health Fungal keratitis is a severe ocular infection caused by filamentous fungi or yeasts, with a high risk of vision loss or even blindness. It poses a serious threat to ocular health. Currently, Natamycin (NATACYN®) is the only FDA-approved treatment for FK. However, limitations such as drug resistance and low bioavailability highlight the urgent need for more effective therapeutic options.  Expert Commentary on IVIEW-1201  Professor Ting Wang from the Affiliated Eye Hospital at Shandong First Medical University, the lead investigator of the nationwide Phase II clinical trial of IVIEW-1201 for the treatment of bacterial conjunctivitis, commented: "IVIEW-1201, through its unique antimicrobial mechanism and innovative delivery approach, has demonstrated the ability to rapidly eliminate a wide range of pathogens—including fungi, bacteria, and viruses—while minimizing the risk of resistance. Its sustained-release profile and high safety margin make it a promising candidate. The FDA's orphan drug designation recognizes the scientific innovation and targeted therapeutic rationale behind IVIEW-1201 and marks a key milestone toward advancing treatment for fungal keratitis. We look forward to its progression into clinical trials in this important field."  CEO Statement  Dr. Bo Liang, Founder, Chairman, and CEO of IVIEW Therapeutics Inc., stated: "The FDA's orphan drug designation for IVIEW-1201 is a strong endorsement of our scientific innovation. FK patients have long faced limited treatment options, and IVIEW-1201 offers the potential to become a differentiated therapy. We look forward to accelerating its clinical development and bringing a safer and more effective solution to patients in need."  Next Steps  The company plans to initiate a Phase II clinical trial to evaluate the efficacy and safety of IVIEW-1201 compared to NATACYN® in patients with fungal keratitis. The trial will focus on key endpoints such as the resolution of corneal lesions, fungal clearance rate, and improvement in visual acuity.  About IVIEW Therapeutics Inc.  IVIEW Therapeutics Inc. is a clinical-stage biotechnology company dedicated to developing innovative ophthalmic therapies. We are committed to scientific innovation to deliver differentiated products that address unmet medical needs. With a focus on novel mechanisms of action and unique drug delivery technology platforms, we aim to develop assets with potentially superior target product profiles.  Our pipeline includes innovative small molecule and gene therapy candidates targeting dry eye disease, myopia, conjunctivitis, glaucoma, presbyopia, and other ocular disorders. Headquartered in Cranbury, New Jersey, in the Princeton area, IVIEW occupies 11,045 square feet of laboratory and office space.  For more information, please visit our website at www.iviewtherapeutics.com or contact us at [email protected].

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