iVeena Announces IND Submission to the U.S. FDA for a Phase 2 Clinical Trial for Pediatric Myopia

IVMED-85 is a non-atropine daily eye drop intended to treat pediatric myopia by strengthening scleral and corneal collagen crosslinking through LOX^* activation

Myopia Affects ~40%^** of Children in the US and Remains a Critical Unmet Medical Need

SALT LAKE CITY--(BUSINESS WIRE)--iVeena Delivery Systems Inc. (“iVeena”), a biopharmaceutical company advancing IVMED-85 for the treatment of pediatric myopia, today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for IVMED-85 for the treatment of pediatric myopia.

“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, M.D., Ph.D., 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, 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. The submission 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.

About 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 that strengthens scleral and corneal collagen crosslinks through LOX activation, potentially leading to improved refraction and a decrease in the rate of axial elongation.

About iVeena

iVeena Delivery Systems, Inc. is a privately held, clinical stage ophthalmology company developing disease-modifying pharmacologic innovations for refractive diseases. iVeena has licensed its lead asset to Glaukos Corporation, IVMED-80, an Orphan Drug Designated eye drop for keratoconus. iVeena is developing IVMED-85, a first in class, investigational eyedrop formulation for pediatric myopia.

About Myopia

Myopia, also known as nearsightedness, is a common eye condition where distant objects appear blurry while close objects can be seen clearly. It occurs when the eye grows too long from front to back, causing light to focus in front of the retina rather than directly on it. Myopia typically begins in childhood and tends to progress with age. If left unmanaged, it can increase the risk of serious eye complications later in life, including retinal detachment, glaucoma, and myopic macular degeneration. The global rise in myopia—particularly among children—has become a significant public health concern.

* Lysyl oxidase (LOX) is a copper ion-dependent amino-acyl oxidase
** Clin Ophthalmol. 2018 Aug 29;12:1581–1587. doi: 10.2147/OPTH.S164641