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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

International journal of molecular sciences, 2022-12, Vol.24 (1), p.554 [Periódico revisado por pares]

Switzerland: MDPI

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  • Título:
    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
  • Autor: Sosne, Gabriel ; Kleinman, Hynda K ; Springs, Clark ; Gross, Robert Hollis ; Sung, Jihye ; Kang, Shinwook
  • Assuntos: clinical trial ; Cornea - metabolism ; Corneal Dystrophies, Hereditary - metabolism ; corneal healing ; Double-Blind Method ; Humans ; Keratitis - drug therapy ; neurotrophic keratopathy ; ocular discomfort ; Ophthalmic Solutions - pharmacology ; Thymosin - metabolism ; thymosin ß4 ; Treatment Outcome ; Trigeminal Nerve Diseases - metabolism
  • É parte de: International journal of molecular sciences, 2022-12, Vol.24 (1), p.554
  • Notas: ObjectType-Article-1
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  • Descrição: 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 ( = 0.0656), indicating a strong efficacy trend. Additional efficacy was seen in the significant healing ( = 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 ( = 0.0818, 0.0625, and 0.0467, respectively). Time to complete healing also showed a trend towards efficacy ( = 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.
  • Editor: Switzerland: MDPI
  • Idioma: Inglês
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  • Realização: ABCD-USP USP   Logos de Redes Sociais: Freepik

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