iVeena Delivery Systems Announces Positive End-of-Phase 1 FDA Meeting for IVMED-85

FDA supports advancement of IVMED-85 into Phase 2 clinical development for pediatric myopia and provides alignment on key elements of the development program

SALT LAKE CITY--(BUSINESS WIRE)--iVeena Delivery Systems, Inc., “iVeena” a clinical-stage ophthalmic pharmaceutical company developing innovative therapies for eye diseases, today announced a successful End-of-Phase 1 Type B meeting with the U.S. Food and Drug Administration (FDA) for IVMED-85, an investigational, non-atropine eye drop being developed for the treatment of pediatric myopia.

The meeting followed the recently announced successful completion of iVeena's Phase 1 clinical study evaluating the safety and tolerability of IVMED-85 in healthy adult volunteers. During the meeting, the FDA confirmed that the Phase 1 clinical data, together with the Company's previously completed nonclinical toxicology program, support advancement into pediatric Phase 2 clinical development.

The FDA also provided constructive feedback and alignment on key aspects of the Company's proposed Phase 2 clinical development program, including study design, efficacy endpoints, statistical analysis, and overall development strategy. The meeting provides iVeena with a clear regulatory framework as it finalizes its Phase 2 protocol and advances IVMED-85 through clinical development.

"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 feedback from the FDA, iVeena will finalize the Phase 2 protocol. When submitted under an active IND protocol are subject to the FDA's standard 30-day review process before patient enrollment. iVeena also discussed longer-term development plans during the meeting, including considerations for pivotal Phase 3 studies. The FDA provided valuable feedback that will help optimize iVeena's overall clinical development strategy as the program progresses.

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.

IVMED-85 has successfully completed a randomized, double-masked, vehicle-controlled Phase 1 clinical study demonstrating a favorable safety and tolerability profile in healthy adult volunteers and is being advanced into Phase 2 clinical development in a pediatric population.

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.