# Prevention of Children's Tympanostomy Tube Otorrhea

> **NIH NIH R44** · O-RAY PHARMA, INC. · 2020 · $284,456

## Abstract

Project Summary
Otitis media (infection of the middle ear space) is one of the most common diseases of childhood. Myringotomy
with tympanostomy tube (TT) insertion is the most common operation performed on children in the United
States. Otorrhea is the most common complication following tube insertion and can occur in up to 17% of ears
receiving TT and is often associated with active infection. Current treatments involve the administration of
antibiotic or antibiotic/steroid drops twice a day for 14 days. Though this decreases the incidence of infection,
there are issues with patient compliance and temporary conductive hearing loss in the children. An enhanced
treatment option would improve treatment efficacy and increase patient compliance.
This CRP SBIR proposal involves the preparation of materials for the initiation of clinical trials for an extended
release hydrogel to deliver steroids and antibiotics locally for the treatment of TT associated otorrhea. The
aims of this proposal are threefold: First, designing and planning for a Phase 1 clinical trial, including
completion of the Investigator's Brochure. Second, the development of a regulatory strategy, including
compiling documents for submission of an IND, holding a pre-IND meeting with the FDA, and submitting the
IND. Lastly, technical assistance associated with manufacturing, specifically identifying contract manufacturers
for scale-up of GMP production of material for Phase 2/3 clinical trials. The completion of this project will
situate the company for obtaining follow-on funding for the completion of Phase I clinical studies.
The team of investigators at O-Ray is uniquely qualified to perform the work proposed herein, and has
expertise in otology, drug development and drug delivery for the successful development this product. O-Ray
scientists have successfully developed therapeutic formulations that are currently being used in the clinic. This
includes an intraocular sustained release steroid implant capable of maintaining anti-inflammatory intravitreal
drug levels for periods of up to 3 years from a single implantation. The next stage of this project will involve the
obtaining investment Angel/Venture groups for the initiation of clinical trials.

## Key facts

- **NIH application ID:** 10011523
- **Project number:** 2R44DC014416-04
- **Recipient organization:** O-RAY PHARMA, INC.
- **Principal Investigator:** Matthew Ku
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $284,456
- **Award type:** 2
- **Project period:** 2014-09-16 → 2022-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10011523

## Citation

> US National Institutes of Health, RePORTER application 10011523, Prevention of Children's Tympanostomy Tube Otorrhea (2R44DC014416-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10011523. Licensed CC0.

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