# Noregen, a regenerative medicine ocular therapeutic

> **NIH NIH R44** · RETINAL SOLUTIONS LLC · 2024 · $720,183

## Abstract

ABSTRACT
Ischemic retinopathies, such as diabetic retinopathy and retinal vein occlusion, are the leading cause
of blindness in the United States. Common features are leaky vessels, swelling, capillary drop out,
aberrant vessel growth and retinal detachment. Current treatments include laser ablation, anti-VEGFs
and steroids. All are sub-optimal and only serve to slow disease progression and vision loss, and do
not repair or regenerate the damaged vessels. Laser treatment is used to ablate avascular/ischemic
regions of the retina to reduce the hypoxic drive which causes the abnormal vascular permeability,
exudation and neovascularization. Anti-VEGFs and steroids transiently reduce vascular permeability
but do not aid in normal retinal blood vessel repair or regeneration. However, the current product,
Noregen (a norrin derived growth factor) restores vessel integrity and regenerates new non-
fenestrated capillaries. Proof of principal was established in the most widely employed animal model
for ischemic retinopathies, the mouse Oxygen Induced Retinopathy (OIR) model. In this Phase II
project, we will optimize dosing of intravitreal injections, create and qualify analytical methods that will
be used to establish product release criteria, and run preliminary pharmacokinetics studies to support
an FDA IND submission. The long term goal of this project is to create a novel therapy for ischemic
retinopathies that will restore the retina rather than simply slow pathology and vision loss.

## Key facts

- **NIH application ID:** 10877981
- **Project number:** 5R44EY030807-03
- **Recipient organization:** RETINAL SOLUTIONS LLC
- **Principal Investigator:** Kimberly Drenser
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $720,183
- **Award type:** 5
- **Project period:** 2019-09-01 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10877981

## Citation

> US National Institutes of Health, RePORTER application 10877981, Noregen, a regenerative medicine ocular therapeutic (5R44EY030807-03). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10877981. Licensed CC0.

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