Key Takeaways
- IVMED-85 demonstrated a favorable safety profile in a first-in-human phase 1 study involving 36 healthy adult volunteers, with no serious adverse events reported
- The investigational therapy targets lysyl oxidase activation to strengthen scleral collagen, representing a mechanism distinct from muscarinic receptor antagonists used in myopia management
iVeena Delivery Systems has completed a phase 1 clinical trial evaluating the safety of IVMED-85, an investigational preservative-free ophthalmic solution for pediatric myopia, with results supporting advancement of the program into phase 2 clinical development.
The first-in-human, randomized, double-masked, vehicle-controlled study enrolled 36 healthy adult volunteers who were randomized 1:1 to receive either IVMED-85 or vehicle twice daily for 6 weeks. All participants completed the study.
The trial met its primary objective of evaluating safety and tolerability. Investigators reported no serious adverse events or adverse events of special interest during the study. Ocular treatment-emergent adverse events, including irritation, hyperemia, and pruritus, were described as mild, transient, and self-limited, resolving without intervention. The company also reported no clinically significant changes in visual acuity, intraocular pressure, corneal or conjunctival fluorescein staining, intraocular inflammation, or dilated fundus examination findings.
"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."
IVMED-85 is designed to activate lysyl oxidase, a naturally occurring copper-dependent enzyme involved in collagen crosslinking within the sclera. According to the company, lysyl oxidase activity is reduced in children with myopia, and restoring scleral biomechanical integrity may help address the axial elongation that contributes to disease progression. The investigational therapy differs mechanistically from currently available pharmacologic approaches that target muscarinic receptors, instead aiming to address an underlying structural component of myopia 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."
Following completion of the phase 1 trial, iVeena said it plans to continue discussions with the FDA as it advances development of IVMED-85. The company is preparing to initiate a phase 2 pediatric clinical program that will evaluate the dosing, safety, and efficacy of the investigational therapy in children with progressive myopia.
