iVeena Secures $2 Million NIH Grant to Advance First-in-Class Pediatric Myopia Eye Drop
核心洞察
iVeena Delivery Systems (搜索) received a $2 million Phase 2 SBIR grant from the National Eye Institute to develop IVMED-85, a novel topical eye drop for pediatric myopia (搜索).
The preservative-free therapy works through a unique mechanism that enhances corneal and scleral crosslinking while avoiding side effects of current off-label treatments.
With over 20 million affected children in the US and no FDA-approved therapies available, this represents a significant unmet medical need.
iVeena Delivery Systems (搜索), a clinical-stage ophthalmology company, has been awarded a $2 million Phase 2 Small Business Innovation Research (SBIR) grant from the National Eye Institute (NEI) of the National Institutes of Health to advance development of a first-in-class topical eye drop for pediatric myopia (搜索). The funding will support research into IVMED-85, an investigational preservative-free prescription eye drop designed to prevent myopia progression in children.
Addressing a Critical Unmet Medical Need
Myopia (搜索) affects more than 20 million children in the United States, with global prevalence expected to exceed 3 billion people by 2030. Pediatric myopia significantly increases the risk of serious, lifelong eye diseases including retinal detachment (搜索), myopic maculopathy (搜索), cataract (搜索), and glaucoma (搜索). Despite the magnitude of this public health issue, no FDA-approved pharmacologic therapies currently exist to slow myopia progression.
"Controlling pediatric myopia (搜索) is an opportunity to meaningfully improve lifelong eye health on a global scale," said Dr. Bala Ambati, President and Co-Founder of iVeena. "We deeply appreciate the NEI's support in advancing this promising new therapy."
Novel Mechanism of Action
IVMED-85 represents a non-surgical, non-invasive, non-atropine daily eye drop that strengthens scleral and corneal collagen crosslinks through lysyl oxidase (搜索) (LOX) activation. This novel mechanism enhances corneal and scleral crosslinking while avoiding the dilation and anticholinergic side effects associated with current off-label treatments. The approach potentially leads to improved refraction and a decrease in the rate of axial elongation.
The research is led by Sarah Molokhia, PhD, Vice President of Research & Development at iVeena and Adjunct Assistant Professor in the Department of Molecular Pharmaceutics at the University of Utah. "The NEI has been extremely supportive of our research, and we are very grateful for their continued partnership," said Dr. Molokhia. "This grant allows us to advance our program and better understand how our proprietary eye drops may transform the treatment of pediatric myopia (搜索)."
Clinical Development Progress
iVeena submitted an Investigational New Drug (IND) application to the US Food and Drug Administration for IVMED-85 for the treatment of pediatric myopia (搜索) in June 2025. The company plans to initiate a multinational Phase 2 study in the coming months.
"This announcement is an important milestone for iVeena in our journey to offer patients a novel therapeutic option," commented President and founder Bala Ambati, MD, PhD, 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."
The NIH NEI grant, titled "Topical Eyedrops Increasing Lysyl Oxidase (搜索) and Dopamine Activity to Control Myopia (搜索)" (Award number: 2R44EY034770-02), will explore disease mechanisms and further evaluate how iVeena's novel eye drop may slow or halt the progression of myopia in children.
Company Pipeline
iVeena Delivery Systems (搜索) is developing disease-modifying pharmacologic innovations for refractive diseases. The company has licensed its lead asset, IVMED-80, an Orphan Drug Designated eye drop for keratoconus (搜索), to Glaukos Corporation. IVMED-85 represents the company's first-in-class investigational eyedrop formulation specifically targeting pediatric myopia (搜索).