# Late-stage Pre-clinical Development and GMP Production of a First-in-Class Extended Release IOP-lowering Formulation

> **NIH NIH R44** · TAVO BIOTHERAPEUTICS, INC · 2024 · $1,066,178

## Abstract

Glaucoma is a multifactorial, polygenetic disease that is the leading cause of irreversible blindness worldwide.
Trends predict that by 2040, ~112 million people worldwide will have glaucoma, and many of those will be
legally blind. Several risk factors are known for this disease, with elevated intraocular pressure (IOP) and
fluctuations in IOP being the only modifiable risk factors linked to the development and progression of visual
field loss. Because of the critical role played by IOP, the current standard of care for adult-onset
glaucoma includes treatment with IOP-lowering medications that are delivered topically as eye drops.
Unfortunately, notwithstanding the convenience of instilling eye drops at home, patient adherence is a major
challenge making it essential that topical dosage forms be engineered to mitigate side effects and eliminate IOP
fluctuations. A market-based comparison has identified multiple issues with current glaucoma medications, the
most significant of which are: 1) limited options for different drug classes/mechanisms of action that are needed
when tolerance to treatment develops; 2) lack of sustained IOP-lowering action, thus requiring many patients to
apply eye drops 2-3 times daily to avoid IOP fluctuations, which are now known to be highly deleterious; and 3)
side effects¾intolerable orbital and systemic discomfort and hyperemia, iris pigmentation changes¾that
contribute to poor patient compliance. We have identified a new druggable target for the treatment of glaucoma,
as well as a highly promising drug and formulation to address all the above listed pain points and unmet needs.
Previous support from NIH SBIR Phase 1 and R24 awards to the OculoTherapy team allowed us to make
excellent progress on the optimization of a novel, topical IOP-lowering formulation, which addresses all the
major limitations listed above. Our formulation is engineered to be bioadhesive with extended-release
properties. In addition, it is well-tolerated, based on the outcomes of a non-GLP 7-day repeat-escalating dose
exploratory toxicity study. Moreover, IOP fluctuations are eliminated, beginning with the first topical application,
and the effectiveness has not waned after 8 months of daily dosing. The active pharmaceutical ingredient
¾pregabalin (PRG)¾represents a new IOP-lowering drug class and provides an additional therapeutic option
when current treatments fail. Because PRG is a safe and efficacious drug, our regulatory strategy is
streamlined. Our patent portfolio is robust and relies of composition of matter and use patents. Importantly, via a
June 2023 Type-B pre-IND meeting with the FDA, OculoTherapy obtained agreement for our regulatory
strategy, plan and pathway to IND and NDA approvals. Specifically, because of the extensive systemic safety
data that is available on PRG, the FDA has agreed to allow OculoTherapy to pursue a 505(b)(2) regulatory
pathway, which will save both time and cost. This Phase II SBIR application was crafted ...

## Key facts

- **NIH application ID:** 10922072
- **Project number:** 1R44EY036343-01
- **Recipient organization:** TAVO BIOTHERAPEUTICS, INC
- **Principal Investigator:** Dianna Ammons Johnson
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,066,178
- **Award type:** 1
- **Project period:** 2024-09-01 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10922072

## Citation

> US National Institutes of Health, RePORTER application 10922072, Late-stage Pre-clinical Development and GMP Production of a First-in-Class Extended Release IOP-lowering Formulation (1R44EY036343-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10922072. Licensed CC0.

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