SALT LAKE CITY--(BUSINESS WIRE)--iVeena Delivery Systems (iVeena), a clinical stage biopharmaceutical company with developmental products in keratoconus and pediatric myopia, announces successful completion of a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development plan for a novel pharmacologic treatment of pediatric myopia.
IVMED-85 enables physiologic crosslinking in the sclera and cornea to arrest progression of myopia. The investigational formulation is a once daily topical eye drop. This innovative approach and mechanism of action have previously not been studied clinically. In line with this novel approach the FDA confirmed a 505(b)(1) regulatory submission is appropriate, a drug development pathway for products with no prior regulatory approvals.
Key nonclinical and clinical development milestones were discussed at the meeting. The FDA provided guidance in support of iVeena’s proposed first in human trial, as well as gave clear expectations for endpoints and design of the future pivotal clinical program that will aim to define the product’s safety and efficacy needed for approval. Additionally, clarity was provided regarding the structure and species of the toxicology program.
“We appreciate the guidance from the FDA as we move into the toxicology program and prepare for the clinic in 2022,” said iVeena CEO Jerry Simmons. “This engagement with the FDA is significant progress for IVMED-85 development and gives us confidence in our development plan of this novel therapeutic.”
IVMED-85 is an investigational eyedrop formulation containing copper intended for treatment of pediatric myopia. Copper ion is a cofactor for lysyl oxidase (LOX) activity, which mediates physiologic collagen crosslinking and is reduced in myopic sclera. IVMED-85 will be the first eye drop inducing both scleral and corneal crosslinking for myopia control.
About Pediatric Myopia
Myopia, also known as nearsightedness, is a vision condition in which people can see close objects clearly, but objects farther away appear blurred. Myopia is considered an epidemic and is projected to inflict half the world population by the year 2050. The incidence of myopia increases throughout the childhood years, typically beginning at about age 5 or 6 and may worsen as the child ages. Nearsightedness poses risks to kids including playground or activity injuries, impaired academic performance, and increased risk of developing glaucoma, cataract, maculopathy, and retinal detachment. Slowing the progression of myopia could enhance quality of life and long-term ocular health.
iVeena Delivery Systems, Inc. is a privately held, clinical stage ophthalmology company developing a non-surgical, non-invasive, pharmacologic innovation. This novel disease modifying intervention addresses a significant unmet need in the advancement of corneal diseases and myopic conditions. The company’s lead programs comprise novel proprietary eye drops; IVMED-80, granted Orphan Drug Designation, for keratoconus and IVMED-85 for myopia.