# Topical Eyedrop Therapy for Keratoconus

> **NIH NIH R44** · IVEENA DELIVERY SYSTEMS, INC. · 2020 · $771,002

## Abstract

Project Summary
Keratoconus (KCN) is a corneal disorder in which the central portion of the cornea becomes thinner and bulges
forward in a cone-shaped fashion resulting in myopia, irregular astigmatism, and eventually visual impairment.
The earliest signs of keratoconus are usually blurred vision and frequent changes in eye glass prescription, or
vision that cannot be corrected with glasses. Symptoms of keratoconus generally begin in the late teenage years
or early twenties, but can start at any time. Treatment options are surprisingly limited with no oral or topical
pharmaceutical therapy. Most mild KCN can be corrected with glasses or soft contact lenses but very often
patients will need toric or hard contacts as the disease progresses. Ultimately, 1 in 5 patients will require surgery,
such as corneal transplant or UV-A crosslinking, which poses significant risks of scarring, visual haze, fluctuation,
and pain.
Our technology, IVMED-80 eye drops, is based on a co-factor for lysyl oxidase (LOX) activity. Deficient LOX
activity in the cornea has been linked to the development of keratoconus both genetically and biochemically.
Using Phase 1 funding support, we were able to restore lysyl oxidase activity in human corneal fibroblasts from
keratoconic corneas and increase levels of crosslinked collagen as measured by lysylnorleucine in rabbit eyes.
We demonstrated topical therapy increased biomechanical strength of human cadaver corneas and rabbit
corneas as measured by both extensiometry ex vivo and waveform deformation analysis in vivo. Finally, topical
copper therapy induced flattening of the rabbit cornea comparable to levels observed with conventional surgical
crosslinking in humans. This body of data resulted in iVeena being granted orphan designation for IVMED-
80.
In this Phase 2 SBIR project, we propose experiments that will enable us to submit an IND and start a US clinical
trial. We propose to analyze optimal duration of therapy and potential risk of relapse after different durations of
treatment, manufacture a GMP batch with stability testing according to ICH guidelines, and perform a 6-month
GLP toxicology study in rabbits.

## Key facts

- **NIH application ID:** 10078047
- **Project number:** 1R44EY031224-01A1
- **Recipient organization:** IVEENA DELIVERY SYSTEMS, INC.
- **Principal Investigator:** Sarah Abdulla Molokhia
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $771,002
- **Award type:** 1
- **Project period:** 2020-09-01 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10078047

## Citation

> US National Institutes of Health, RePORTER application 10078047, Topical Eyedrop Therapy for Keratoconus (1R44EY031224-01A1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10078047. Licensed CC0.

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