iVeena Delivery Systems Announces Successful Phase 1 Results for IVMED-85, a First-in-Class Lysyl Oxidase Activator for Pediatric Myopia
核心洞察
iVeena completed a Phase 1 trial of IVMED-85 in 36 healthy adults, demonstrating favorable safety and tolerability with no serious adverse events observed.
IVMED-85 is a novel, preservative-free ophthalmic solution that activates lysyl oxidase (搜索) to restore scleral biomechanical integrity, addressing a root cause of myopia progression.
All ocular treatment-emergent adverse events were mild, transient, and self-limited, with no clinically significant changes in visual acuity or intraocular pressure.
iVeena Delivery Systems (搜索), Inc., a clinical-stage ophthalmic biopharmaceutical company, announced the successful completion of its Phase 1 clinical trial of IVMED-85, an investigational, preservative-free ophthalmic solution for the treatment of pediatric myopia (搜索). The first-in-human, randomized, double-masked, vehicle-controlled study met its objectives, demonstrating a favorable safety and tolerability profile that supports advancement into Phase 2 clinical development.
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. All 36 randomized subjects successfully completed the study, with no dropouts reported.
Safety and Tolerability Findings
The trial's safety outcomes were notably clean. No serious adverse events or adverse events of special interest were observed throughout the six-week treatment period. Ocular treatment-emergent adverse events — including irritation, hyperemia, and pruritus — were all characterized as mild, transient, and self-limited, resolving without any intervention.
Importantly, investigators observed no clinically significant changes across a comprehensive battery of ophthalmic assessments, including visual acuity, intraocular pressure, corneal or conjunctival fluorescein staining, intraocular inflammation, and 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 (搜索) 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."
A Differentiated Mechanism of Action
IVMED-85 stands apart from existing pharmacologic approaches to myopia management, which have largely relied on muscarinic receptor antagonism — most notably atropine. Instead, IVMED-85 is designed to activate lysyl oxidase (搜索) (LOX), a naturally occurring copper-dependent enzyme responsible for collagen crosslinking within the sclera. This enzymatic activity is known to be reduced in children with myopia.
By restoring the biomechanical integrity of the sclera through enhanced collagen crosslinking, IVMED-85 directly addresses a pathophysiological mechanism believed to contribute to axial elongation and myopic progression. The therapy is formulated as a non-surgical, non-invasive, non-atropine daily eye drop.
"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."
Next Steps Toward Phase 2
With the Phase 1 data in hand, iVeena is actively advancing preparations for its Phase 2 pediatric clinical program, which will evaluate the dosing, safety, and efficacy of IVMED-85 in children with progressive myopia. The company also indicated that completion of this trial represents an important milestone as it prepares for continued interactions with the U.S. Food and Drug Administration regarding the future clinical development of IVMED-85.
iVeena Delivery Systems (搜索) is a privately held, clinical-stage ophthalmology company focused on developing disease-modifying pharmacologic innovations for refractive diseases. The company previously licensed its lead asset, IVMED-80 — an Orphan Drug Designated eye drop for keratoconus (搜索) — to Glaukos, Inc. (搜索)