iVeena Completes Pre-IND Meeting with FDA for Treatment of Pediatric Myopia

iVeena Completes Pre-IND Meeting with FDA for Treatment of Pediatric Myopia

November 11, 2021

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

IVMED-85 stops myopia progression by allowing physiologic crosslinking in the sclera and cornea. The investigational formulation is a topical eye drop that is used once a day. This novel technique and mechanism of action have never been investigated in a clinical setting before.

The FDA acknowledged that a 505(b)(1) regulatory submission, a medication development pathway for items with no prior regulatory approvals, is suitable in accordance with this unique approach.

Key nonclinical and clinical development milestones were highlighted at the meeting.

The FDA provided guidance in support of iVeena’s proposed first in human trial, as well as specific expectations for endpoints and the design of the future pivotal clinical program that will try to establish the product's safety and efficacy required for approval.

In addition, 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 a copper-based investigational eye drop formulation for the treatment of pediatric myopia. Copper ion is a cofactor for lysyl oxidase (LOX) activity, which is decreased in myopia sclera and mediates physiologic collagen crosslinking.

IVMED-85 will be the first myopia-controlling eye drop to induce both scleral and corneal crosslinking.