IVIEW Therapeutics’ IVIEW-1201 Gains FDA Orphan Drug Designation for Fungal Keratitis

IVIEW Therapeutics' IVIEW-1201 Gains FDA Orphan Drug Designation for Fungal Keratitis

China-based IVIEW Therapeutics Inc. announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for IVIEW-1201, a 1.0% povidone iodine eye gel sterile solution. This designation is for the treatment of fungal keratitis (FK), a serious eye infection caused by filamentous fungi or yeast affecting the cornea.

Disease Background
Fungal keratitis is a severe ocular disease that poses a significant threat to vision, often leading to vision loss or blindness if left untreated. The condition is typically caused by infections from filamentous fungi or yeast, emphasizing the critical need for effective antifungal therapies.

Current Treatment Landscape
Currently, Natacyn (natamycin), developed by Harrow, Inc., is the only FDA-approved topical ophthalmic antifungal for fungal keratitis. IVIEW-1201 represents a novel approach to addressing this condition, offering a new treatment option for patients with limited therapeutic choices.

IVIEW-1201 Mechanism
IVIEW-1201 is a sterile solution containing 1.0% povidone iodine, a broad-spectrum antiseptic. Its mechanism of action involves disrupting fungal cell membranes, making it effective against a range of pathogens responsible for fungal keratitis. This innovative formulation is designed to provide targeted antifungal activity while minimizing systemic exposure.-Fineline Info & Tech