Key Takeaways

  • A Phase 2 randomized, double-masked, multicenter study evaluated 3 concentrations of TTAX03 against saline control in 74 adults with mild to moderate dry eye disease

  • No treatment-related serious adverse events were reported, and the highest dose demonstrated the greatest improvements in dry eye symptoms and corneal staining outcomes

BioTissue will present results from a phase 2 clinical study evaluating the safety and potential efficacy of investigational TTAX03 in patients with mild to moderate dry eye disease (DED) at the American Academy of Ophthalmology (AAO) 2026 annual meeting in New Orleans.

The prospective, randomized, controlled, double-masked, multicenter study enrolled 74 adults who were randomized in a 1:1:1:1 ratio to receive 1 of 3 TTAX03 concentrations or saline control. Each treatment was administered under a bandage contact lens for 5 days.

The study's primary objective was to evaluate ocular and general safety through 12 weeks.

According to BioTissue, no treatment-related serious adverse events were reported in any treatment group.

The highest TTAX03 concentration demonstrated the greatest improvements in overall symptoms and eye dryness, as measured by the visual analogue scale (VAS). This group also showed a higher incidence of complete resolution of corneal staining and changes in best-corrected visual acuity (BCVA) at Day 85.

The findings suggest a favorable preliminary safety profile, with the highest dose showing the greatest improvements in clinical signs and patient-reported symptoms. However, additional studies are needed to further assess efficacy and determine the optimal dose and treatment regimen.

“Dry eye is not a one-size-fits-all condition, making ongoing exploration into new approaches especially important,” said Ted Davis, president and CEO of BioTissue, in a company statement.

BioTissue noted that its development of regenerative products derived from human birth and placental tissues continues to inform its investigation of new therapeutic applications.

The findings will be presented during the AAO Annual Meeting, scheduled for October 9–12, 2026, in New Orleans.