timbetasin ophthalmic (RGN-259) / ReGenTree 
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 27 Diseases   1 Trial   1 Trial   98 News 
  • ||||||||||  timbetasin topical (RGN-137) / RegeneRx, timbetasin ophthalmic (RGN-259) / ReGenTree
    Journal:  Thymosin beta 4: A potential novel adjunct treatment for bacterial keratitis. (Pubmed Central) -  Apr 25, 2023   
    Our previous work has shown that topical T?4 as an adjunct to ciprofloxacin treatment reduces inflammatory mediators and inflammatory cell infiltrates (neutrophils/PMN and macrophages) while enhancing bacterial killing and wound healing pathway activation in an experimental model ofP...Adjunctive thymosin beta 4 treatment holds novel therapeutic potential to regulate and, optimally, resolve disease pathogenesis in the cornea and perhaps other infectious and immune-based inflammatory disease. We plan to establish the importance of thymosin beta 4 as a therapeutic agent in conjunction with antibiotics with high impact for immediate clinical development.
  • ||||||||||  timbetasin ophthalmic (RGN-259) / ReGenTree
    Enrollment open, Trial initiation date:  Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2 (clinicaltrials.gov) -  Feb 23, 2023   
    P3,  N=70, Recruiting, 
    We plan to establish the importance of thymosin beta 4 as a therapeutic agent in conjunction with antibiotics with high impact for immediate clinical development. Not yet recruiting --> Recruiting | Initiation date: Nov 2022 --> Mar 2023
  • ||||||||||  timbetasin ophthalmic (RGN-259) / ReGenTree
    Trial completion:  Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3 (clinicaltrials.gov) -  May 9, 2022   
    P3,  N=700, Completed, 
    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. Active, not recruiting --> Completed
  • ||||||||||  timbetasin ophthalmic (RGN-259) / ReGenTree
    SEER-1 Demonstrates Safety and Efficacy of RGN-259 for Neurotrophic Keratopathy (Morial Convention Center) -  Oct 20, 2021 - Abstract #AAO2021AAO_1782;    
    No treatment emergent adverse events led to study discontinuation. Conclusions In a small study, the efficacy and safety of RGN-259 validate that RGN-259 represents a potential first-line therapy for NK.
  • ||||||||||  timbetasin ophthalmic (RGN-259) / ReGenTree
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1 (clinicaltrials.gov) -  Jul 2, 2020   
    P3,  N=18, Terminated, 
    Trial primary completion date: Aug 2020 --> Nov 2020 N=46 --> 18 | Trial completion date: Sep 2020 --> Mar 2020 | Recruiting --> Terminated | Trial primary completion date: Aug 2020 --> Nov 2019; Business decision
  • ||||||||||  timbetasin ophthalmic (RGN-259) / ReGenTree
    Trial completion date, Trial primary completion date:  Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3 (clinicaltrials.gov) -  Jun 1, 2020   
    P3,  N=700, Recruiting, 
    N=46 --> 18 | Trial completion date: Sep 2020 --> Mar 2020 | Recruiting --> Terminated | Trial primary completion date: Aug 2020 --> Nov 2019; Business decision Trial completion date: Jul 2020 --> Nov 2020 | Trial primary completion date: Apr 2020 --> Aug 2020
  • ||||||||||  timbetasin ophthalmic (RGN-259) / ReGenTree
    Trial completion date, Trial primary completion date:  Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1 (clinicaltrials.gov) -  Sep 9, 2019   
    P3,  N=46, Recruiting, 
    In conclusion, RGN-259 promoted recovery of mucins and goblet cells, improved corneal integrity, and reduced inflammation in a dry eye mouse model and was equal to or more effective than prescription treatments. Trial completion date: Aug 2019 --> Sep 2020 | Trial primary completion date: May 2019 --> Aug 2020
  • ||||||||||  timbetasin ophthalmic (RGN-259) / ReGenTree
    Trial completion, Trial completion date, Trial primary completion date:  Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2 (clinicaltrials.gov) -  Sep 7, 2018   
    P3,  N=601, Completed, 
    Trial completion date: Nov 2018 --> Aug 2019 | Trial primary completion date: Sep 2018 --> May 2019 Active, not recruiting --> Completed | Trial completion date: Nov 2018 --> Mar 2018 | Trial primary completion date: Nov 2018 --> Sep 2017
  • ||||||||||  timbetasin ophthalmic (RGN-259) / ReGenTree
    Trial completion date, Trial primary completion date:  Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2 (clinicaltrials.gov) -  Apr 17, 2018   
    P3,  N=601, Active, not recruiting, 
    Active, not recruiting --> Completed | Trial completion date: Nov 2018 --> Mar 2018 | Trial primary completion date: Nov 2018 --> Sep 2017 Trial completion date: Nov 2017 --> Nov 2018 | Trial primary completion date: Nov 2017 --> Nov 2018