Investigational therapy shows favorable safety profile; highest dose associated with greatest improvements in dry eye symptoms and corneal staining

MIAMI, FL, UNITED STATES, October 9, 2026 /EINPresswire.com/ -- BioTissue will present results from a prospective, randomized, controlled, double-masked, multicenter Phase 2 study evaluating TTAX03 in adults with mild to moderate dry eye disease at the American Academy of Ophthalmology (AAO) Annual Meeting. The study randomized 74 patients in a 1:1:1:1 ratio to one of three TTAX03 concentrations or saline control, with each treatment administered under a bandage contact lens for five days. The study’s primary objective was to evaluate ocular and general safety through 12 weeks.

“BioTissue has pioneered the clinical development and application of regenerative products derived from human birth and placental tissues, and continuing this work reflects that spirit of innovation while advancing new applications that may help more patients,” said Ted Davis, President and CEO of BioTissue. “Dry eye is not a one-size-fits-all condition, making ongoing exploration into new approaches especially important.”

No treatment-related serious adverse events were reported in any group. The highest dose demonstrated the greatest improvement in overall symptoms and eye dryness as measured using the visual analogue scale (VAS), a higher incidence of complete resolution of corneal staining, and change in best-corrected visual acuity (BCVA) at Day 85.

The findings suggest that this investigational product appears safe, with the highest dose showing the largest improvement in signs and symptoms in patients with mild to moderate DED. Additional research will be needed to further evaluate efficacy and establish the appropriate dose and treatment regimen.

The American Academy of Ophthalmology meeting will take place Oct. 9-12 in New Orleans. Presentation details and the complete conference program are available at www.aao.org.

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About BioTissue, Inc.
BioTissue^® is an emerging biotechnology company and leader in harnessing the unique power of human birth tissue to support regenerative healing across a wide variety of conditions throughout the body, specializing in ocular surface disease, neurotrophic keratitis, and non-healing corneal defects. BioTissue’s portfolio of cryopreserved amniotic membrane products use its proprietary CryoTek^® cryopreservation technology, designed to retain the tissue's structural and functional integrity. The company continues to break new ground with multiple Investigational New Drug (IND) clinical trials as the company pursues Biologic License Applications (BLAs) for products to treat patients' unmet clinical needs. BioTissue is committed to empowering healthcare professionals with solutions to deliver optimal patient outcomes by fostering innovation through evidence-based science. Since its inception, clinicians have performed over 1 million human implants with its products and published 420 peer-reviewed publications supporting BioTissue's platform technology. Learn more at biotissue.com.

Wendy Boyce
McDougall Communications
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