iVeena Delivery Systems Inc., a clinical-stage ophthalmology company, has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for IVMED-85, a novel eye drop designed to treat pediatric myopia. The submission marks a significant regulatory milestone for the company's lead program targeting a condition that affects approximately 40% of children in the United States.
Novel Mechanism Targets Collagen Crosslinking
IVMED-85 represents a first-in-class approach to pediatric myopia treatment through its unique mechanism of action. The preservative-free daily eye drop works by strengthening scleral and corneal collagen crosslinks through lysyl oxidase (LOX) activation, a copper ion-dependent amino-acyl oxidase. This non-surgical, non-invasive approach potentially leads to improved refraction and a decrease in the rate of axial elongation, addressing the underlying structural changes associated with myopic progression.
"This IND marks a major step toward meeting a significant unmet need for patients. IVMED-85's novel LOX-based mechanism offers a differentiated, non-atropine approach that could redefine how we treat pediatric myopia," said Vance Thompson, M.D., Founder of Vance Thompson Vision Sioux Falls, South Dakota, and the Director of Refractive Surgery.
Addressing Critical Unmet Medical Need
Myopia, also known as nearsightedness, occurs when the eye grows too long from front to back, causing light to focus in front of the retina rather than directly on it. The condition typically begins in childhood and tends to progress with age. If left unmanaged, myopia can increase the risk of serious eye complications later in life, including retinal detachment, glaucoma, and myopic macular degeneration. The global rise in myopia, particularly among children, has become a significant public health concern.
The development of IVMED-85 as a non-atropine alternative is particularly significant given the limitations of current treatment options. As a new chemical entity (NCE), the formulation offers a differentiated therapeutic approach for preventing myopic progression in pediatric patients.
Regulatory Timeline and Clinical Development
The IND submission includes detailed information about IVMED-85's composition, pharmacology, toxicology data from preclinical studies, proposed clinical trial protocols, and manufacturing and quality control information. With the application now complete, the FDA is expected to provide its review within approximately 30 days.
"Today's announcement is an important milestone for iVeena in our journey to offer patients a novel therapeutic option," said President and Founder, Bala Ambati, M.D., Ph.D., MBA. "I am extremely proud of the remarkable commitment of the team at iVeena and look forward to initiating our multinational Phase 2 study in the coming months."
Pending FDA approval, iVeena plans to initiate the multinational clinical trial in 2025. The company is a privately held, clinical-stage ophthalmology company developing disease-modifying pharmacologic innovations for refractive diseases. iVeena has previously licensed its lead asset IVMED-80, an Orphan Drug Designated eye drop for keratoconus, to Glaukos Corporation.
