iVeena Submits IND Application for Phase 2 Trial of IVMED-85 in Pediatric Myopia

iVeena Delivery Systems has announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for IVMED-85, a novel eye drop therapy intended for the treatment of pediatric myopia.

A Non-Atropine, Noninvasive Approach

IVMED-85 is a preservative-free, non-surgical, noninvasive, and non-atropine daily eye drop formulated to prevent the progression of myopia in children. As a new chemical entity (NCE), IVMED-85 functions through activation of lysyl oxidase (LOX), a mechanism aimed at strengthening scleral and corneal collagen crosslinks. This effect is intended to reduce axial elongation and improve refractive outcomes.

“Today’s announcement is an important milestone for iVeena in our journey to offer patients a novel therapeutic option,” said Bala Ambati, MD, PhD, President and Founder of iVeena. “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.”

Expert Perspective and Trial Plans

Vance Thompson, MD, Founder of Vance Thompson Vision in Sioux Falls, South Dakota, and Director of Refractive Surgery, emphasized the clinical relevance: “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.”

An IND submission to the FDA is required to obtain authorization for the initiation of clinical trials in human subjects. The FDA is expected to complete its review of the application within approximately 30 days. Subject to approval, iVeena plans to initiate the multinational phase 2 clinical trial of IVMED-85 in 2025.