HY-091

HY-091 is a novel mucoadhesive film product being co-developed by Hyloris Pharmaceuticals and AFT Pharmaceuticals for the treatment of Vulvar Lichen Sclerosus (VLS), a chronic inflammatory disease affecting the vulvar area. The drug is formulated as a user-friendly mucosal adhesive patch that provides extended-duration release of a known pharmaceutical compound, although the specific active ingredient remains confidential. HY-091 is designed to offer targeted relief for patients experiencing discomfort, itching, and pain associated with VLS by reducing inflammation and scarring in the affected skin area and helping restore skin structure. The convenient application method aims to ensure simplicity and improve patient compliance. The drug is being developed using the FDA's 505(b)(2) regulatory pathway, which utilizes the established safety and efficacy of existing molecular entities in a new formulation.