Progress and Approval of the Corneal Epithelial Clinical Trial and Dependence on the Outsourcing Agreement with NIDEK
First written in FY2016. 2 of 3 entries say "Mitigated", first in FY2020. Latest entry: FY2022-Q1.
The whole theme swung hardest in 2020: 9 of 45 companies on the "Worse" side.
9 other companies' latest entry also says "Mitigated".
- FY2022-Q1MitigatedAnnual report
「Autologous cultured oral mucosal epithelium, marketed as Ocural, for which the company had applied to the Ministry of Health, Labour and Welfare for manufacturing and marketing approval in September 2020, received approval dated 11 June 2021. The company aims to promote the use of regenerative medicine in ophthalmology in cooperation with NIDEK, the ophthalmic medical device manufacturer responsible for sales.」
For Ocural, an autologous cultured oral mucosal epithelium product sold by NIDEK, approval was obtained after the application was filed, reducing uncertainty surrounding the approval process. - FY2020MitigatedAnnual report
「In March 2020, the company obtained manufacturing and marketing approval for a product intended to treat limbal stem cell deficiency, received insurance coverage from June of the same year, and became the first regenerative medicine product in Japan in the ophthalmology field.」
For the autologous cultured corneal epithelium product, uncertainty surrounding the clinical trial and approval process was reduced by obtaining approval. The contract development agreement with NIDEK also ended upon approval. - FY2016First statedAnnual report
「However, if the collection of clinical trial cases does not progress as expected, or if the expected efficacy and safety cannot be demonstrated, the subsequent regulatory approval process may not proceed as anticipated.」
The main uncertainties are the collection of clinical trial cases, demonstration of efficacy and safety, and changes in the policy of NIDEK, the commissioning party, or a reduction in the scope of the contract.