iVeena submits IND to FDA for a phase 2 clinical trial for pediatric myopia

The preservative-free prescription eye drop IVMED-85 is being developed by iVeena Delivery Systems, a privately held, clinical stage ophthalmology company that formulates disease-modifying pharmacologic interventions for refractive diseases.

(Image credit: ©OHishi_Foto—stock.adobe.com)

iVeena Delivery Systems announced the Investigational New Drug (IND) submission to the FDA for IVMED-85, an investigational eye drop for the prevention of pediatric myopia progression. IVMED-85 is a new chemical entity; the preservative-free, non-atropine daily drop strengthens scleral and corneal collagen crosslinks through lysyl oxidase (LOX) activation to improve refraction and decrease the rate of axial elongation.¹

“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,” Vance Thompson, MD, founder of Vance Thompson Vision in Sioux Falls, South Dakota, and the director of refractive surgery, said in a press release.

The preservative-free prescription eye drop IVMED-85 is being developed by iVeena Delivery Systems, a privately held, clinical stage ophthalmology company that formulates disease-modifying pharmacologic interventions for refractive diseases. Its other development, IVMED-80, is an Orphan Drug Designated eye drop for keratoconus and has been licensed by Glaukos.¹

History of IVMED-85

Results of IVMED-85 in a guinea pig model were first presented at ARVO 2019. Safety and efficacy of the drop were investigated in albino guinea pigs with spontaneous myopia, which is thought to be the most similar to myopia in humans. Each guinea pig was dosed with IVMED-85 twice daily for 8-10 weeks in one eye, with the other eye either dosed with vehicle or left untreated as the control. Refractive error and axial length were measured as well as corneal curvature and central corneal thickness.⁴

No toxicity was observed in the dissected eye following the study, and IOP measurements were within normal limits (15-25 mm HG) at all points of the study. IVMED-85 effectively reduced myopia progression in treated eyes while untreated eyes continued to progress. While there was no difference in axial length between treated and untreated eyes, the eyes treated with IVMED-85 showed decreased corneal curvature compared to control eye.⁴

In October 2023, Sarah Molokhia, RPh, PhD—adjunct assistant professor in the department of pharmaceutics and pharmaceuticals at the University of Utah and the vice president of research and development at iVeena—received the National Eye Institute Phase 1 Small Business Innovative Research grant to develop and investigate IVMED-85 for pediatric myopia control.² In February 2025, iVeena announced that it had secured $3 million in Series B-2 financing to support the IVMED-85 investigational program.³

Following the submission, the FDA is expected to review within 30 days. If positively reviewed, iVeena Delivery Systems intends to initiate a multinational clinical trial in 2025.¹

References

1. iVeena Announces IND Submission to the U.S. FDA for a Phase 2 Clinical Trial for Pediatric Myopia. iVeena. News release. Published June 2, 2025. Accessed June 4, 2025. https://iveenamed.com/news/iveena-announces-ind-submission-to-the-u-s-fda-for-a-phase-2-clinical-trial-for-pediatric-myopia

2. iVeena Awarded NEI-SBIR Grant For Progressive Myopia Drug Candidate IVMED-85. iVeena. News release. Published October 26, 2023. Accessed June 4, 2025. https://iveenamed.com/news/iveena-awarded-nei-sbir-grant-for-progressive-myopia-drug-candidate-ivmed-85

3. iVeena Secures $3 Million in Series B-2 Financing to Accelerate Development of IVMED-85 for Myopia. iVeena. News release. Published February 5, 2025. Accessed June 4, 2025. https://iveenamed.com/news/iveena-secures-3-million-in-series-b-2-financing-to-accelerate-development-of-ivmed-85-for-myopia

4. Molokhia S, Hauritz H, Archer B, Burr M, Owen LA, Ambati BK. IVMED-85 eye drops for myopia control in guinea pigs. Invest Ophthal Vis Sci. 2019;60(9):5896.