iVeena Delivery Systems announced the Investigational New Drug (IND) submission to the US Food and Drug Administration (FDA) for IVMED-85, an investigational eye drop for the prevention of pediatric myopia progression. IVMED-85 is a new chemical entity; the preservative-free, non-atropine daily drop strengthens scleral and corneal collagen crosslinks through lysyl oxidase activation to improve refraction and decrease the rate of axial elongation, according to the company. Following the submission, the FDA is expected to review within 30 days. If positively reviewed, iVeena Delivery Systems intends to initiate a multinational clinical trial in 2025.
The company’s other development, IVMED-80, is an eye drop for keratoconus that has received orphan drug designation from the FDA and has been licensed by Glaukos.