# Pharmaceutical development of longer-lasting brimonidine eye drops

> **NIH NIH R44** · NOVUS VISION LLC · 2024 · $964,469

## Abstract

PROJECT SUMMARY
Glaucoma is the leading cause of irreversible blindness, impacting 80 million people worldwide. The only
proven approach to prevent vision loss in glaucoma is the reduction of intraocular pressure (IOP), which is
most commonly achieved by topical medications. Once daily (QD) prostaglandins are a typical first-line
therapy, though the need for adjunctive therapy with other drug classes is very common. Several studies have
suggested that the addition of brimonidine, an alpha-2 agonist, is the most effective for IOP lowering.
Brimonidine is also preferred as a frontline therapy for normal tension glaucoma and patients undergoing laser
trabeculoplasty or iridotomy, and has been shown to have potential neuroprotective benefits independent of
IOP lowering. However, brimonidine is prescribed for three times daily (TID) dosing. The more drops glaucoma
patients are required to take per day, the more likely it is that issues with adherence and symptoms of ocular
surface disease develop. Thus, there is a significant opportunity to develop eye drops that can be used less
frequently while also mitigating or even alleviating symptoms of concomitant dry eye disease. Novus Vision
Inc. is developing a novel hypotonic thermosensitive gelling eye drop (OcuGel) that is liquid at room
temperature and spreads to cover the ocular surface immediately and uniformly, forming a clear gel to trap the
medication in place. Further, the gel coating provides sustained ocular surface lubrication and tear film
stabilization to alleviate symptoms of dry eye. We have observed that when formulating our OcuGel vehicle
containing brimonidine tartrate (OcuGel BT), OcuGel BT provided increased and more sustained IOP lowering
compared to Alphagan P. To further enhance and sustain IOP lowering to achieve a QD product, here we aim
to reformulate at the highest brimonidine concentration previously approved and marketed, 0.2%.
Reformulation work in Aim 1 will involve creating formulations with pharmaceutically appropriate buffering and
preservation for shelf stability and repeat use packaging, and to demonstrate stability under accelerated
degradation conditions and sterility using industry standard tests. We will identify at least three formulations at
in Aim 1 for pharmacodynamic evaluations and preclinical safety testing in rabbits in Aim 2. Using these data
and our plan for IND-enabling studies in Aim 3, we will then engage in a pre-IND meeting with the FDA. Based
on FDA feedback, we will contract to perform GLP bottle fills, stability and sterility and to perform GLP toxicity
studies in rabbits and mini-pigs. Upon completion of Aim 3, we will have an appropriate data package for an
IND submission.

## Key facts

- **NIH application ID:** 10932173
- **Project number:** 5R44EY035177-02
- **Recipient organization:** NOVUS VISION LLC
- **Principal Investigator:** Laura Ensign
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $964,469
- **Award type:** 5
- **Project period:** 2023-09-30 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10932173

## Citation

> US National Institutes of Health, RePORTER application 10932173, Pharmaceutical development of longer-lasting brimonidine eye drops (5R44EY035177-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10932173. Licensed CC0.

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