US biopharmaceutical company iVeena has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for its IVMED-85 eye drop for the treatment of paediatric myopia. 

IVMED-85 is a preservative-free non-atropine prescription eye drop. Used daily, it’s designed to strengthen scleral and corneal collagen crosslinks through lysyl oxidase (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,” said president and founder, Dr Bala Ambati. “We 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 paediatric myopia,” said Dr Vance Thompson, director of refractive surgery and founder of Vance Thompson Vision Sioux Falls, South Dakota.  

The FDA is expected to provide its review of the IND application within approximately 30 days. Pending approval, iVeena plans to initiate the multinational clinical trial in 2025. 

*Lysyl oxidase (LOX), is an enzyme which plays a critical role in the structure and function of connective tissues.