COMPANY

Corporate History

Apr 2002 Acugen Neuropeutics Inc. was established in Seattle, Washington, USA, under the laws of State of Washington, to develop methods of treatment for degenerative eye diseases and pharmaceutical compound screening system
Mar 2003 Acugen Neuropeutics Inc. renamed as Acucela Inc.
Oct 2005 Initiated Visual Cycle Modulation (VCM) development
Mar 2006 Relocated Acucela headquarters to Bothell, Washington
Apr 2006 Initiated development for emixustat hydrochloride (emixustat), the lead VCM-based product candidate for the treatment of retinal diseases
Aug 2006 Opened Tokyo Office in Shinagawa Ward, Tokyo, Japan
May 2008 IND (investigational new drug) for emixustat for geographic atrophy secondary to dry age-related macular degeneration (GA secondary to dry AMD) was filed with the FDA (US Food and Drug Administration)
Jun 2008 Initiated Phase 1 clinical trial of emixustat for GA secondary to dry AMD
Sep 2008 Announced co-development and commercialization agreement with Otsuka Pharmaceutical Co., Ltd. for emixustat
Mar 2010 Announced FDA Fast Track designation for emixustat for GA secondary to dry AMD
Sep 2010 Relocated Acucela headquarters to Seattle, Washington
Apr 2013 Initiated Phase 2/3b clinical trial of emixustat for GA secondary to dry AMD
Sep 2013 Tokyo Office relocated to Shibuya Ward, Tokyo, Japan
Feb 2014 Acucela Initial Public Offering on Tokyo Stock Exchange Mothers Board
May 2015 Announced publication of pre-clinical data of emixustat for GA secondary to dry AMD
Jun 2015 Announced publication of results from Phase 2a clinical trial of emixustat for GA secondary to dry AMD
Dec 2015 Incorporated a subsidiary, Acucela Japan KK (eventual Kubota Pharmaceutical Holdings Co., Ltd.) in Japan
Mar 2016 Announced an exclusive option to license novel cataract treatment from UC San Diego and YouHealth Eyetech, Inc.
Apr 2016 Announced an exclusive license agreement for gene therapy from the University of Manchester, UK, for the treatment of retinal degenerative disease
May 2016 Initiated Phase 2 clinical trial with emixustat for proliferative diabetic retinopathy
May 2016 Announced top-line results from Phase 2b/3 clinical trial of emixustat for GA secondary to dry AMD
Jun 2016 Announced the termination of emixustat co-development and promotion agreement with Otsuka Pharmaceutical Co., Ltd.
Dec 2016 Completed the triangle merger and the redomicile transaction; Acucela Inc. is a wholly owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd.
Dec 2016 Kubota Pharmaceutical Holdings Co., Ltd. listed on the Tokyo Stock Exchange Mothers Board
Dec 2016 Announced R&D agreement to exclusively acquire novel retinal technology from University of Southern California and EyeMedics, LLC
Jan 2017 Announced FDA Orphan Drug Designation for emixustat for Stargardt disease
Jan 2017 Initiated Phase 2a clinical trial of emixustat for Stargardt disease
Feb 2017 Initiated development for home-based medical monitoring OCT device
Jun 2017 Tokyo Office relocated to Chiyoda Ward, Tokyo, Japan
Jan 2018 Announced a two-year development agreement with SIRION Biotech GmbH for gene delivery tools for ocular gene therapy
Jan 2018 Announced results from Phase 2 clinical trial of emixustat for proliferative diabetic retinopathy
Jan 2018 Announced results from Phase 2a clinical trial of emixustat for Stargardt disease
Mar 2018 Announced initiation of clinical trial for PBOS device
Nov 2018 Announced PBOS device clinical trial completion and results
Nov 2018 Initiated Phase 3 clinical trial of emixustat for Stargardt disease