Key Takeaways

• The FDA agreed that phase 1 clinical data and existing nonclinical toxicology findings support advancement of IVMED-85 into pediatric phase 2 development
• The agency provided feedback on the proposed Phase 2 study design, efficacy endpoints, statistical analysis, and broader clinical development strategy

iVeena Delivery Systems has completed a successful end-of-phase 1 Type B meeting with the FDA for IVMED-85, its investigational eye drop for pediatric myopia, receiving agency feedback that supports advancement of the program into phase 2 clinical development.

According to the company, the meeting followed completion of a phase 1 clinical trial evaluating the safety and tolerability of IVMED-85 in healthy adult volunteers. The FDA agreed that the phase 1 clinical findings, together with the company's previously completed nonclinical toxicology package, provide sufficient support to begin pediatric phase 2 studies.

During the meeting, the agency also provided feedback on several elements of the proposed phase 2 program, including study design, efficacy endpoints, statistical analysis, and the overall clinical development strategy. iVeena said the discussions establish a regulatory framework as it finalizes the phase 2 protocol.

"We are very pleased with the outcome of this important regulatory milestone," said Michael Burr, chief operating officer of iVeena. "The FDA's feedback provides a clear path forward for our pediatric phase 2 study and reflects the productive collaboration we've had with the Agency throughout development. We appreciate the thoughtful guidance received during the meeting and look forward to advancing IVMED-85 into the next stage of clinical development."

Based on the agency's feedback, iVeena plans to finalize its phase 2 protocol and submit it under its active investigational new drug (IND) application. The protocol will be subject to the FDA's standard 30-day review period before patient enrollment can begin.

The company also discussed its longer-term clinical development plans during the meeting, including considerations for potential pivotal phase 3 studies. iVeena said the FDA's input will help inform the program's future development strategy.

IVMED-85 is a preservative-free, investigational prescription eye drop designed to slow myopia progression in pediatric patients. The therapy is a new chemical entity and is intended to provide a non-surgical, non-invasive, non-atropine treatment option administered once daily. According to iVeena, the investigational therapy is designed to strengthen scleral and corneal collagen crosslinks through lysyl oxidase (LOX) activation, with the goal of reducing axial elongation and potentially improving refractive outcomes.