SALT LAKE CITY — iVeena Delivery Systems Inc. has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for IVMED-85, a novel eye drop intended to treat pediatric myopia. The move represents a significant step forward in developing a non-atropine therapy to address a growing vision problem affecting millions of children.
IVMED-85 is designed to treat myopia by strengthening scleral and corneal collagen through the activation of lysyl oxidase (LOX), an enzyme involved in collagen crosslinking. This mechanism offers a new approach to slowing the progression of myopia without the side effects commonly associated with atropine-based treatments.
Pediatric myopia, which now affects approximately 40 percent of children in the United States, remains a critical unmet medical need with limited treatment options. If successful, iVeena’s therapy could represent a major advancement in managing the condition, which can lead to serious long-term vision complications if left untreated.
“Today’s IND submission marks an important milestone for iVeena as we continue our mission to deliver innovative treatments for vision-threatening conditions,” said Bala Ambati, M.D., Ph.D., MBA, President and Founder of iVeena. “I am incredibly proud of our team’s dedication and look forward to launching our Phase 2 multinational trial in the near future.”
Dr. Vance Thompson, Director of Refractive Surgery at Vance Thompson Vision in Sioux Falls, South Dakota, emphasized the potential impact of the therapy. “This novel LOX-based mechanism could reshape how we approach pediatric myopia,” he said. “It represents a promising, differentiated strategy that doesn’t rely on atropine.”
The IND submission includes comprehensive preclinical data on the safety and pharmacology of IVMED-85, along with the proposed design for the upcoming clinical trial. The FDA typically responds to IND submissions within 30 days. If approved, iVeena expects to begin the Phase 2 trial in 2025, enrolling participants across multiple international sites.
The development of IVMED-85 underscores iVeena’s commitment to advancing new therapies for underserved eye conditions and may ultimately offer a new standard of care for children facing progressive vision loss.
