Development progress status of treatment for dry eye syndrome
Progress status | |
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Korea | • Approved IND for Phase IIb/III clinical trial to the Ministry of Food and Drug Safety • Completed to manufacture investigational medicinal product in Korea depending on the schedule of the clinical trial |
United States | • Contracted with Ora, Inc., a CRO/SMO company in the US that specialized in ophthalmological diseases to conduct clinical trials in the US. Using the CAE™(Controlled Adverse Environment) model for more effective and rapid clinical trial of treatment for Dry Eye Syndrome • Completed a Phase IIb/III clinical trial(ARISE-1) of GBT-201 for the treatment of Dry Eye Syndrome in the US • Conducting a 2nd Phase III clinical trial(ARISE-2) of GBT-201 for treatment of Dry Eye Syndrome in the US • Approved by the U.S.-based joint venture (ReGenTree, LLC) 3rd phase (ARISE-3) of treatment of Dry Eye Syndromeㅍ (GBT-201) • treatment of Dry Eye Syndrome (GBT-201) Martket Access Study in progress • Completed investigational products manufacturing in a FDA cGMP-certified foreign CMO |
*Related link
http://www.clinicaltrials.gov/ct2/show/NCT01387347?term=thymosin+beta+4&rank=6
https://www.clinicaltrials.gov/ct2/show/NCT01393132?term=thymosin+beta+4&rank=7
Development progress status of treatment for neurotrophic keratopathy
Progress status | |
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United States | • Received orphan drug designation from the US FDA. • Concluded contract with Ora, Inc., a CRO and SMO company that specializes in ophthalmic diseases for conducting Phase III clinical trial. • Conducting a Phase III clinical trial(SEER-1) of GBT-201 for treatment of Neurotrophic Keratopathy in the US • Completed investigational products manufacturing in a FDA cGMP-certified foreign CMO |
*Related link
http://www.ncbi.nlm.nih.gov/pubmed/20536469
http://www.ncbi.nlm.nih.gov/pubmed/20457990