iVeena Delivery Systems Inc. announced it has submitted an investigational new drug (IND) application to the FDA on behalf of IVMED-85, the company’s pediatric myopia candidate.
First, this company.
Headquartered in Salt Lake City, Utah, iVeena is a privately held, clinical-stage ophthalmic company.
Its focus: Developing disease-modifying pharmacologic assets—proprietary ophthalmic solutions, to be specific—for refractive diseases.
- Included in this pipeline:
- IVMED-80, its lead investigational candidate for keratoconus (licensed to Glaukos Corporation)
- IVMED-85 (our topic of conversation)
Let’s talk about this myopia asset.
iVeena has developed IVMED-85 as a “new chemical entity (NCE),” which the FDA refers to as a novel, small, chemical molecule drug that is either currently undergoing clinical trial investigation or has previously received FDA approval for use in other drugs.
- Importantly: An NCE contains no active molecules (moiety).
And its components?
The asset is formulated as an eye drop that is:
- Preservative-free (PF)
- Prescription-based
- Administered once daily
- Non-atropine-based
So how does it treat pediatric myopia?
IVMED-85 is intended to strengthen scleral and corneal collagen crosslinks via Lysol oxidase (LOX) activation that could in turn lead to:
- Improved refraction
- A decrease in axial elongation (AE) rate
Back up. Explain how LOX is linked to myopia.
LOX is a copper ion-dependent enzyme that, by oxidizing lysine residues to aldehydes, stimulates the covalent crosslinking (CXL) of collagen and elastin.
Because of collagen CXL: Collagen combines into insoluble collagen fibrils—which could be key for scleral remodeling.Why scleral remodeling is important: As this process has been linked to axial elongation (AE), it is critical in myopia development and progression.
Noted. And do we know what age group IVMED-85 targets?
Aside from a pediatric patient base—not specifically, no. However, the drop is intended for a twice-daily (BID) dosing.
How about prior clinical data on it?
Here’s what we know about this:
When IVMED-85 was awarded a Phase 1 Small Business Innovative Research (SBIR) grant from the National Eye Institute in 2023, we learned of an IND-enabling project that reportedly provided the “first evidence” of IVMED-85’s potential.
Specifically: In preliminary results, the eye drop induced “biochemical crosslinking and biomechanical stiffening in cornea and sclera and reduced refraction and vitreous depth in guinea pig myopic model.”
- As for the project itself: It sought to test IVMED-85’s safety in rabbits to determine its safety and efficacy and generate feasibility results.
- To note, though: We don’t have any results from this to share.
Gotcha. Now about this IND submission…
When reviewing an IND submission, the FDA generally looks to ensure the safety and rights of the research subjects, as well as the quality of the scientific evaluation of the drug.
The review may include:
- Pharmacology and toxicology data from preclinical trials
- Proposed clinical trial protocols
- Info on manufacturing and quality control
How long does this review typically take?
Once received, the FDA has 30 days to review the application and determine if a clinical trial is safe to proceed.
- Generally: The application will go into effect 30 days after receipt (providing there is no clinical hold on it), or potentially earlier if the agency gives notice to a sponsor (the company or investigator of the trial).
Per federal rules, an IND-approved clinical trial’s start date must be at least 30 days after the FDA’s application acceptance.
And in iVeena’s case?
Pending no holds, iVeena plans to move forward with initiating a “multinational phase 2 study” within the next few months, according to President and founder Bala Ambati, MD, PhD, MBA.