iVeena Announces Successful Completion of Pre-IND Meeting with FDA

iVeena Delivery Systems announced completion of a pre-investigational new drug (IND) meeting with the FDA regarding the development plan for a novel pharmacologic treatment of pediatric myopia.

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, a drug development pathway for products with no prior regulatory approvals.

Key nonclinical and clinical development milestones were discussed at the meeting. The FDA provided guidance in support of iVeena’s proposed first in 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.

"We appreciate the guidance from the FDA as we move into the toxicology program and prepare for the clinic in 2022," iVeena CEO Jerry Simmons said in a company news release. "This engagement with the FDA is significant progress for IVMED-85 development and gives us confidence in our development plan of this novel therapeutic."

IVMED-85 is an investigational eyedrop formulation containing copper intended for treatment of pediatric myopia. Copper ion is a cofactor for lysyl oxidase (LOX) activity, which mediates physiologic collagen crosslinking and is reduced in myopic sclera. IVMED-85 will be the first eye drop inducing both scleral and corneal crosslinking for myopia control.