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
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