# Novel Ophthalmic Product for Corneal Infections and Injuries

> **NIH NIH R41** · BIOLYTX PHARMACEUTICALS CORP · 2021 · $256,580

## Abstract

Biolytx Pharmaceuticals Corp. is developing a peptide, BP001, derived from the human endogenous host
defense protein CAP37, as a novel multi-target ophthalmic product for corneal infections and injuries. The
standard-of-care for corneal infections is topical administration of antibiotics that may be accompanied by topical
steroids, to limit the destructive effect of the resulting corneal inflammation. The efficacy of antibiotics is limited
by the alarming increase of resistant bacteria, and the use of steroids is limited by their potential adverse effects
(recrudescent infection, increased intraocular pressure). BP001 has multiple beneficial effects and is developed
as a new product to mitigate these limitations. It is bactericidal, restores the sensitivity of resistant Pseudomonas
aeruginosa to fluoroquinolones, promotes corneal re-epithelialization, and based on our recent results, is
predicted to be anti-inflammatory through inhibition of a toll-like receptor. Interestingly, we recently observed that
the composition of the buffer used to prepare BP001 greatly affects its bactericidal properties in vitro. Building
on this observation, our specific aims in this phase I application are to 1) develop and optimize an ophthalmic
formulation of BP001 to potentiate the effective killing of P. aeruginosa, and 2) demonstrate the benefit of using
the optimized formulation for treatment of bacterial keratitis with BP001 alone and in combination with ofloxacin.
We will use the Quality by design (QbD) approach to develop a formulation that meets critical quality attributes,
defined as (a) enhances the bactericidal potency (at least 10-fold compared to the original saline solution, (b)
does not irritate the eye, (c) enhances retention of the solution in the eye to maximize the effect of BP001 at the
site of action, and d) does not interfere with the bactericidal potency of ofloxacin when used in combination.
Measured outcomes will be viscosity, minimum bactericidal concentrations, and synergistic effects of BP001 and
ofloxacin prepared in formulations and tested on sensitive and resistant strains of P. aeruginosa. We will then
use the formulation optimized in aim 1 to evaluate enhancement of BP001 bactericidal activity in vivo. We will
conduct dose-responses of BP001 and ofloxacin in saline and formulation, and a dose-response of the
BP001/ofloxacin combination treatment prepared in formulation, using a mouse model of bacterial keratitis
induced by a resistant strain of P. aeruginosa. At the conclusion of phase I, we expect to have developed a
formulation that enhances BP001 bactericidal effects and supports efficient clearing of bacterial keratitis induced
by a resistant P. aeruginosa isolate by the BP001/ofloxacin combination. In phase II, we will demonstrate wound
healing and anti-inflammatory effects of BP001, in mouse models of keratitis and corneal abrasion, using the
formulation optimized in phase I. Completion of this project will advance the develop...

## Key facts

- **NIH application ID:** 10156366
- **Project number:** 1R41EY032437-01
- **Recipient organization:** BIOLYTX PHARMACEUTICALS CORP
- **Principal Investigator:** Heloise ANNE Pereira
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $256,580
- **Award type:** 1
- **Project period:** 2021-09-30 → 2023-09-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10156366

## Citation

> US National Institutes of Health, RePORTER application 10156366, Novel Ophthalmic Product for Corneal Infections and Injuries (1R41EY032437-01). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10156366. Licensed CC0.

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