November 11, 2021
SALT LAKE CITY — iVeena Delivery Systems announced that the company has successfully completed a pre-IND (Investigational New Drug) meeting with the FDA. The biopharmaceutical company is currently working on treatments for both keratoconus and myopia, and this meeting was geared toward the myopia drug — IVMED-85.
Key nonclinical and clinical development milestones were discussed at the meeting. The FDA provided guidance in support of iVeena’s proposed first human trial, as well as gave clear expectations for endpoints and design of the future pivotal clinical program that will aim to define the product’s safety and efficacy needed for approval. Additionally, clarity was provided regarding the structure and species of the toxicology program.
IVMED-85 enables physiologic crosslinking in the sclera and cornea to arrest progression of myopia. The investigational formulation is a once daily topical eye drop. This innovative approach and mechanism of action have previously not been studied clinically. In line with this novel approach, the FDA confirmed a 505(b)(1) regulatory submission is appropriate, as that is the drug development pathway for products with no prior regulatory approvals.
“We appreciate the guidance from the FDA as we move into the toxicology program and prepare for the clinic in 2022,” said iVeena CEO Jerry Simmons. “This engagement with the FDA is significant progress for IVMED-85 development and gives us confidence in our development plan of this novel therapeutic.”