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| Presentation preference | Poster presentation |
| Title | A phase I/II clinical trial supports further investigation of TRS01 as a new non-steroid treatment for active noninfectious anterior uveitis, with a novel mechanism of action |
| Purpose | To report results of phase I/II clinical trial of TRS01, an eye drops formulation of TRS, a bio-inspired peptide conjugate of Tuftsin-Phosphorylcholine, with a novel immunomodulator, was evaluated for its safety and efficacy in active non-infectious anterior uveitis. |
| Methods | In a randomized, double masked, dose-ranging phase III trial, 16 patients with active noninfectious anterior uveitis, requiring initiation or additional topical steroid treatment, were randomized to high vs. low-dose of TRS01 (1% vs. 0.1%, QID for 4 weeks, with a 6-week follow-up). Primary endpoint was safety. Efficacy was assessed by Anterior Chamber Cell (ACC) counting by slit-lamp biomicroscopy. |
| Results | TRS01 1% and 0.1% showed favorable safety and tolerability with no treatment related adverse events. TRS01 1% group was superior in terms of ACC reduction at all time points (*P<0.05), despite having the larger portion of severer inflammation cases (75% ACC-Grade-3 at Baseline, and 37.5% chronic patients). 71.4% of subjects in the 1% group reached zero cells on week 3 and 4, and 85.7% reached zero pain on week 1. |
| Conclusion | Results indicate preliminary safety and efficacy of TRS01 1% eye drops in treatment of active non-infectious anterior uveitis signs and symptoms, without raising intraocular pressure. TRS01 will be further investigated in Phase-III trials. |
| Conflict of interest | Yes |
| Details of conflicting interests | I have received financial compensation to conduct trials presented in this abstract |
Authors 1
| Last name | CHU |
| Initials of first name(s) | D |
| Department | Metropolitan Eye Research and Surgery Institute |
| City | Palisades Park, new Jersey |
| Country | United States |
Authors 2
| Last name | Scales |
| Initials of first name(s) | D |
| Department | Ophthalmology |
| City | San Antonio, Texas |
| Country | United States |
Authors 3
| Last name | De-Smet |
| Initials of first name(s) | M |
| Department | Ophthalmology |
| City | Lausanne |
| Country | Switzerland |
Authors 4
| Last name | Neumann |
| Initials of first name(s) | R |
| Department | Ophthalmology |
| City | Tel Aviv |
| Country | Israel |
Authors 5
| Last name | Milman |
| Initials of first name(s) | Z |
| Department | Ophthalmology |
| City | Tel Aviv |
| Country | Israel |
Authors 6
| Last name | Haim-Langford |
| Initials of first name(s) | D |
| Department | Ophthalmology |
| City | Tel Aviv |
| Country | Israel |
