TY  - JOUR
T1  - Regenerative Efficacy of Topical 0.1% Thymosin β4 (RGN-259) in Neurotrophic Keratopathy: Rapid Healing, Reduced Recurrence, and Improved Patient Comfort in a Phase III Trial
A1  - Hyun Woo Park
A1  - Oleksandr V. Petrenko
A1  - Dina M. Saleh
JF  - Bulletin of Pioneering Researches of Medical and Clinical Science
JO  - Bull Pioneer Res Med Clin Sci
SN  - 3006-2659
Y1  - 2023
VL  - 3
IS  - 2
DO  - 10.51847/8tMCYbEW7R
SP  - 99
EP  - 110
N2  - We evaluated how well 0.1% RGN-259 eye drops (formulated with the regenerative peptide thymosin ß4) support the resolution of persistent epithelial lesions in individuals diagnosed with Stage 2 or Stage 3 neurotrophic keratopathy. After 4 weeks, full closure of defects was documented in 6 of the 10 participants treated with RGN-259, compared with 1 of the 8 in the placebo arm (p = 0.0656), suggesting a strong therapeutic signal. Additional evidence of benefit was reflected in the significant healing rate (p = 0.0359), with no defect recurrence noted at day 43—two weeks post-treatment—while the sole placebo responder at day 28 showed relapse at day 43. Improvements in the Mackie stage were recorded at Days 29, 36, and 43 for the RGN-259 cohort (p = 0.0818, 0.0625, and 0.0467). Time-to-healing also favored RGN-259 (p = 0.0829, Kaplan–Meier). Participants receiving RGN-259 reported a significant reduction in ocular discomfort, foreign-body sensation, and dryness at various assessment points, unlike those given placebo. No meaningful safety concerns emerged. Overall, 0.1% RGN-259 accelerated epithelial recovery in neurotrophic keratopathy, enhanced comfort, and demonstrated a favorable safety profile.
UR  - https://bprmcs.com/article/regenerative-efficacy-of-topical-01-thymosin-b4-rgn-259-in-neurotrophic-keratopathy-rapid-heali-uabospgkdw5d4fz
ER  -