June 4, 2025
Photo Credit: Dreamstime Photos
SALT LAKE CITY — iVeena Delivery Systems has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration for its myopia drug, IVMED-85.
“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, MD, PhD, 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.”
“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, MD, Founder of Vance Thompson Vision Sioux Falls, South Dakota, and the Director of Refractive Surgery.
IVMED-85
Lead program IVMED-85 is a new chemical entity (NCE), preservative-free prescription eye drop to prevent myopic progression. IVMED-85 is a non-surgical, non-invasive, non-atropine daily eye drop. It strengthens scleral and corneal collagen crosslinks through LOX* activation. Additionally, the goal is to potentially lead to improved refraction and a decrease in the rate of axial elongation.1
The IND Submission Process
An IND submission is a request submitted to the FDA seeking permission to test a new drug or therapeutic substance in humans. The submission also includes detailed information about the drug, its composition, pharmacology, toxicology data from preclinical studies, proposed clinical trial protocols and information on manufacturing and quality control. With the IND application submission now complete, the FDA is expected to provide its review within approximately 30 days.
Pending approval, the company plans to initiate the multinational clinical trial in 2025.
References
* Lysyl oxidase (LOX) is a copper ion-dependent amino-acyl oxidase.
1 iVeena Announces IND Submission to the U.S. FDA for a Phase 2 Clinical Trial for Pediatric Myopia. iVeena. News release. Published June 2, 2025. Accessed June 4, 2025. https://iveenamed.com/news/iveena-announces-ind-submission-to-the-u-s-fda-for-a-phase-2-clinical-trial-for-pediatric-myopia
