iVeena completes end-of-phase 1 FDA meeting for IVMED-85 in myopia

According to a new announcement from iVeena Delivery Systems, Inc., the company held an End-of-Phase 1 Type B meeting with the FDA for IVMED-85, an investigational non-atropine eye drop under development for pediatric myopia. The FDA confirmed the phase 1 clinical data, along with the company's previously completed nonclinical toxicology program, support advancement into pediatric phase 2 clinical development.

IVMED-85 is a preservative-free prescription eye drop and a new chemical entity intended to prevent myopic progression. The drop is positioned as a non-surgical, non-invasive, non-atropine daily option. Its proposed mechanism involves strengthening scleral and corneal collagen crosslinks through LOX activation.

The regulatory meeting followed completion of a randomized, double-masked, vehicle-controlled phase 1 study evaluating the safety and tolerability of IVMED-85 in healthy adult volunteers. The company reported a favorable safety and tolerability profile in the study population. During the meeting, the FDA provided feedback and alignment on several elements of the proposed phase 2 program, including study design, efficacy endpoints, statistical analysis, and overall development strategy. iVeena said the meeting establishes a regulatory framework as the company finalizes its phase 2 protocol. Longer-term development plans were also discussed, including considerations for pivotal phase 3 studies. The company said the agency's feedback will inform its broader clinical development strategy as the program progresses.

Next steps for the IVMED-85 pediatric program

Based on the FDA feedback, iVeena will finalize the phase 2 protocol. Protocols submitted under an active investigational new drug application are subject to the agency's standard 30-day review process before patient enrollment begins. The company has not disclosed enrollment targets, dosing parameters, or trial sites for the planned pediatric study. Efficacy measures discussed in the announcement center on refraction and the rate of axial elongation, the two outcomes the company states IVMED-85 may improve through its proposed mechanism. No new safety signals were described in the announcement beyond the phase 1 tolerability findings in adults. The company has not stated when the phase 2 study will begin or when data may be available.

"We are very pleased with the outcome of this important regulatory milestone," said Michael Burr, Chief Operating Officer of iVeena, in the release. "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."

IVMED-85 remains investigational and is not available for prescribing. Optometrists managing myopia progression should continue with currently available options. Should the agent advance, it would represent a daily drop alternative to atropine, though no comparative data against existing myopia management approaches have been reported.

Reference:

1. iVeena Delivery Systems, Inc. iVeena Delivery Systems Announces Positive End-of-Phase 1 FDA Meeting for IVMED-85. News release. Businesswire. July 22, 2026. Accessed July 24, 2026. https://www.businesswire.com/news/home/20260722971122/en/iVeena-Delivery-Systems-Announces-Positive-End-of-Phase-1-FDA-Meeting-for-IVMED-85