iVeena Delivery Systems Announces Successful Completion of Phase 1 Clinical Study of IVMED-85

IVMED-85 demonstrated a favorable safety and tolerability profile in healthy adult volunteers, supporting advancement toward Phase 2 clinical development for pediatric myopia

SALT LAKE CITY--(BUSINESS WIRE)--iVeena Delivery Systems, Inc., (“iVeena”) a clinical-stage ophthalmic biopharmaceutical company, today announced the successful completion of its Phase 1 clinical trial evaluating the safety of IVMED-85, an investigational, preservative-free ophthalmic solution being developed for the treatment of pediatric myopia. iVeena has completed the first-in-human, randomized, double-masked, vehicle-controlled Phase 1 study, which demonstrated a favorable safety profile and supports the continued clinical development of IVMED-85 into Phase 2 studies.

The Phase 1 trial enrolled 36 healthy adult volunteers who were randomized 1:1 to receive either IVMED-85 or vehicle twice daily for six weeks.

Key findings from the Phase 1 study include:

• All 36 randomized subjects successfully completed the study.
• No serious adverse events or adverse events of special interest were observed.
• Ocular treatment-emergent adverse events (e.g., irritation, hyperemia, pruritus) were all mild, transient, and self-limited, resolving without intervention.
• No clinically significant changes were observed in visual acuity, intraocular pressure, corneal or conjunctival fluorescein staining, intraocular inflammation, or dilated fundus examinations.

"The successful completion of our first-in-human clinical study represents an important milestone for iVeena and supports the continued development of IVMED-85," said Bala Ambati, MD, PhD, MBA, President and Chief Medical Officer of iVeena. "These results provide encouraging evidence that our novel lysyl oxidase activation approach with IVMED-85, a new chemical entity, was well tolerated in healthy volunteers and supports our confidence as we prepare to advance into Phase 2 clinical evaluation in children with progressive myopia."

Unlike other pharmacologic approaches that rely on muscarinic receptor antagonism, IVMED-85 is designed to activate lysyl oxidase (LOX), a naturally occurring copper-dependent enzyme responsible for collagen crosslinking within the sclera, which is reduced in children with myopia. By restoring the biomechanical integrity of the sclera, IVMED-85 directly addresses a pathophysiological mechanism believed to contribute to axial elongation and myopic progression.

"Our objective has always been to develop a therapy that treats the underlying mechanisms of myopia progression rather than simply managing its symptoms," said Sarah Molokhia, RPh, PhD, Chief Scientific Officer of iVeena. "Completion of this Phase 1 study provides an important foundation for the next stage of development and another meaningful step toward bringing a differentiated treatment option to children affected by progressive myopia."

Completion of the trial represents an important milestone as iVeena prepares for continued interactions with the U.S. Food and Drug Administration regarding the future clinical development of IVMED-85. The Company is actively advancing preparations for its Phase 2 pediatric clinical program designed to evaluate the dosing, safety, and efficacy of IVMED-85 in children with progressive myopia.

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 previously licensed to Glaukos, Inc, lead asset, IVMED-80, an Orphan Drug Designated eye drop for keratoconus. iVeena is developing IVMED-85, a first-in-class, investigational eye drop formulation for pediatric myopia.