iVeena Submits IND Application to the FDA for Phase 2 Clinical Trial for Pediatric Myopia

iVeena Delivery Systems announced the submission of an investigational new drug (IND) application to the FDA for IVMED-85 for the treatment of pediatric myopia.

IVMED-85 is a new chemical entity (NCE), preservative-free prescription eye drop to prevent myopic progression. IVMED-85 is a non-surgical, noninvasive, non-atropine daily eye drop designed to strengthen scleral and corneal collagen crosslinks through LOX activation, potentially leading to improved refraction and a decrease in the rate of axial elongation.

“Today’s announcement is an important milestone for iVeena in our journey to offer patients a novel therapeutic option,” President and Founder, Bala Ambati, MD, PhD, said in a company news release. “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, M.D., Founder of Vance Thompson Vision Sioux Falls, South Dakota, and the Director of Refractive Surgery.

An IND submission is a request submitted to the FDA seeking permission to test a new drug or therapeutic substance in humans. 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.