Cargando…

0.1% RGN-259 (Thymosin ß4) Ophthalmic Solution Promotes Healing and Improves Comfort in Neurotrophic Keratopathy Patients in a Randomized, Placebo-Controlled, Double-Masked Phase III Clinical Trial

We determined the efficacy and safety of 0.1% RGN-259 ophthalmic solution (containing the regenerative protein thymosin ß4) in promoting the healing of persistent epithelial defects in patients with Stages 2 and 3 neurotrophic keratopathy. Complete healing occurred after 4 weeks in 6 of the 10 RGN-2...

Descripción completa

Detalles Bibliográficos
Autores principales: Sosne, Gabriel, Kleinman, Hynda K., Springs, Clark, Gross, Robert Hollis, Sung, Jihye, Kang, Shinwook
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9820614/
https://www.ncbi.nlm.nih.gov/pubmed/36613994
http://dx.doi.org/10.3390/ijms24010554
_version_ 1784865505865105408
author Sosne, Gabriel
Kleinman, Hynda K.
Springs, Clark
Gross, Robert Hollis
Sung, Jihye
Kang, Shinwook
author_facet Sosne, Gabriel
Kleinman, Hynda K.
Springs, Clark
Gross, Robert Hollis
Sung, Jihye
Kang, Shinwook
author_sort Sosne, Gabriel
collection PubMed
description We determined the efficacy and safety of 0.1% RGN-259 ophthalmic solution (containing the regenerative protein thymosin ß4) in promoting the healing of persistent epithelial defects in patients with Stages 2 and 3 neurotrophic keratopathy. Complete healing occurred after 4 weeks in 6 of the 10 RGN-259-treated subjects and in 1 of the 8 placebo-treated subjects (p = 0.0656), indicating a strong efficacy trend. Additional efficacy was seen in the significant healing (p = 0.0359) with no recurrent defects observed at day 43, two weeks after cessation of treatment, while the one healed placebo-treated subject at day 28 suffered a recurrence at day 43. The Mackie classification disease stage improved in the RGN-259-treated group at Days 29, 36, and 43 (p = 0.0818, 0.0625, and 0.0467, respectively). Time to complete healing also showed a trend towards efficacy (p = 0.0829, Kaplan–Meier) with 0.1% RGN-259. RGN-259-treated subjects had significant improvements at multiple time points in ocular discomfort, foreign body sensation, and dryness which were not seen in the placebo group. No significant adverse effects were observed. In summary, the use of 0.1% RGN-259 promotes rapid healing of epithelial defects in neurotrophic keratopathy, improves ocular comfort, and is safe for treating this challenging population of patients.
format Online
Article
Text
id pubmed-9820614
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-98206142023-01-07 0.1% RGN-259 (Thymosin ß4) Ophthalmic Solution Promotes Healing and Improves Comfort in Neurotrophic Keratopathy Patients in a Randomized, Placebo-Controlled, Double-Masked Phase III Clinical Trial Sosne, Gabriel Kleinman, Hynda K. Springs, Clark Gross, Robert Hollis Sung, Jihye Kang, Shinwook Int J Mol Sci Article We determined the efficacy and safety of 0.1% RGN-259 ophthalmic solution (containing the regenerative protein thymosin ß4) in promoting the healing of persistent epithelial defects in patients with Stages 2 and 3 neurotrophic keratopathy. Complete healing occurred after 4 weeks in 6 of the 10 RGN-259-treated subjects and in 1 of the 8 placebo-treated subjects (p = 0.0656), indicating a strong efficacy trend. Additional efficacy was seen in the significant healing (p = 0.0359) with no recurrent defects observed at day 43, two weeks after cessation of treatment, while the one healed placebo-treated subject at day 28 suffered a recurrence at day 43. The Mackie classification disease stage improved in the RGN-259-treated group at Days 29, 36, and 43 (p = 0.0818, 0.0625, and 0.0467, respectively). Time to complete healing also showed a trend towards efficacy (p = 0.0829, Kaplan–Meier) with 0.1% RGN-259. RGN-259-treated subjects had significant improvements at multiple time points in ocular discomfort, foreign body sensation, and dryness which were not seen in the placebo group. No significant adverse effects were observed. In summary, the use of 0.1% RGN-259 promotes rapid healing of epithelial defects in neurotrophic keratopathy, improves ocular comfort, and is safe for treating this challenging population of patients. MDPI 2022-12-29 /pmc/articles/PMC9820614/ /pubmed/36613994 http://dx.doi.org/10.3390/ijms24010554 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Sosne, Gabriel
Kleinman, Hynda K.
Springs, Clark
Gross, Robert Hollis
Sung, Jihye
Kang, Shinwook
0.1% RGN-259 (Thymosin ß4) Ophthalmic Solution Promotes Healing and Improves Comfort in Neurotrophic Keratopathy Patients in a Randomized, Placebo-Controlled, Double-Masked Phase III Clinical Trial
title 0.1% RGN-259 (Thymosin ß4) Ophthalmic Solution Promotes Healing and Improves Comfort in Neurotrophic Keratopathy Patients in a Randomized, Placebo-Controlled, Double-Masked Phase III Clinical Trial
title_full 0.1% RGN-259 (Thymosin ß4) Ophthalmic Solution Promotes Healing and Improves Comfort in Neurotrophic Keratopathy Patients in a Randomized, Placebo-Controlled, Double-Masked Phase III Clinical Trial
title_fullStr 0.1% RGN-259 (Thymosin ß4) Ophthalmic Solution Promotes Healing and Improves Comfort in Neurotrophic Keratopathy Patients in a Randomized, Placebo-Controlled, Double-Masked Phase III Clinical Trial
title_full_unstemmed 0.1% RGN-259 (Thymosin ß4) Ophthalmic Solution Promotes Healing and Improves Comfort in Neurotrophic Keratopathy Patients in a Randomized, Placebo-Controlled, Double-Masked Phase III Clinical Trial
title_short 0.1% RGN-259 (Thymosin ß4) Ophthalmic Solution Promotes Healing and Improves Comfort in Neurotrophic Keratopathy Patients in a Randomized, Placebo-Controlled, Double-Masked Phase III Clinical Trial
title_sort 0.1% rgn-259 (thymosin ß4) ophthalmic solution promotes healing and improves comfort in neurotrophic keratopathy patients in a randomized, placebo-controlled, double-masked phase iii clinical trial
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9820614/
https://www.ncbi.nlm.nih.gov/pubmed/36613994
http://dx.doi.org/10.3390/ijms24010554
work_keys_str_mv AT sosnegabriel 01rgn259thymosinß4ophthalmicsolutionpromoteshealingandimprovescomfortinneurotrophickeratopathypatientsinarandomizedplacebocontrolleddoublemaskedphaseiiiclinicaltrial
AT kleinmanhyndak 01rgn259thymosinß4ophthalmicsolutionpromoteshealingandimprovescomfortinneurotrophickeratopathypatientsinarandomizedplacebocontrolleddoublemaskedphaseiiiclinicaltrial
AT springsclark 01rgn259thymosinß4ophthalmicsolutionpromoteshealingandimprovescomfortinneurotrophickeratopathypatientsinarandomizedplacebocontrolleddoublemaskedphaseiiiclinicaltrial
AT grossroberthollis 01rgn259thymosinß4ophthalmicsolutionpromoteshealingandimprovescomfortinneurotrophickeratopathypatientsinarandomizedplacebocontrolleddoublemaskedphaseiiiclinicaltrial
AT sungjihye 01rgn259thymosinß4ophthalmicsolutionpromoteshealingandimprovescomfortinneurotrophickeratopathypatientsinarandomizedplacebocontrolleddoublemaskedphaseiiiclinicaltrial
AT kangshinwook 01rgn259thymosinß4ophthalmicsolutionpromoteshealingandimprovescomfortinneurotrophickeratopathypatientsinarandomizedplacebocontrolleddoublemaskedphaseiiiclinicaltrial