Conducting clinical trials for autologous cultured corneal epithelium and obtaining early approval
First written in FY2016. 12 of 28 entries say "Advanced", first in FY2017-Q1. Latest entry: FY2026.
No other company in this theme has enough history to compare yet.
- FY2026Sluggish patient growth at existing facilities and progress in adoption by new facilitiesAnnual report
「Orders declined because growth in new patients at existing facilities remained sluggish. Meanwhile, in cooperation with NIDEC CORPORATION, which is responsible for sales, the Company is promoting the development of new facilities and treatment education for potential patients, with results emerging including adoption by one of Japan’s leading new corneal transplant facilities.」
Orders for Nepic and Ocural declined because growth in new patients at existing facilities remained sluggish. Meanwhile, development of new facilities and education of potential patients progressed in cooperation with NIDEC CORPORATION, and the products were adopted by one of Japan’s leading corneal transplant facilities. - 2026-05-28AdvancedGeneral Meetings of Shareholders
「一方で、販売を担う株式会社ニデックとの連携により、新規施設の開拓や潜在患者への治療啓発を推進しており、角膜移植実績のある全国有数の新規施設で採用されるなど成果が現れています。」
既存施設での受注減少を記載する一方、新規施設採用と潜在患者への啓発を進めている。 - FY2026-H1New-patient growth at existing facilities remained sluggish, while new facilities were developed.Annual report
「Orders declined because growth in new patients at existing facilities remained sluggish. Meanwhile, in cooperation with NIDEC CORPORATION, which is responsible for sales, the Company is promoting the development of new facilities and treatment education for potential patients, with results emerging including adoption by a new facility that ranks among the leading corneal transplant facilities nationwide. The Company will continue promoting use by new facilities and treatment education for potential patients, with the aim of recovering orders.」
Orders for Nepic and Ocural declined because growth in new patients at existing facilities remained sluggish. Meanwhile, development of new facilities and treatment education for potential patients progressed in cooperation with NIDEC CORPORATION, and the products were adopted by a leading corneal transplant facility in Japan. - FY2025AdvancedAnnual report
「To accelerate treatment education for corneal specialists and the identification of potential patients, the Company began a new initiative involving the active allocation of its own resources in addition to the sales activities of NIDEC CORPORATION, which is responsible for sales. Joint efforts by both companies to develop candidate facilities and identify potential patients are progressing.」
For Nepic and Ocural, the Company began an initiative allocating its own resources in addition to NIDEC CORPORATION’s existing sales activities, advancing the development of candidate facilities and identification of potential patients. - FY2025-H1AdvancedAnnual report
「Revenue from the corneal field during the six-month period was ¥62.95 million, down 37.3% year on year. Revenue has slowed as transplantations in waiting patients who were candidates reached a peak, but orders began to be received for the fellow eye of patients with bilateral disease who had received Ocural transplantation in one eye. In addition to the sales activities of NIDEC CORPORATION, which is responsible for sales, the Company began a new initiative involving the active allocation of its own resources to promote treatment awareness among physicians and identify potential patients, areas that represent the Company’s strengths.」
In the corneal field, revenue continued to decline as transplantations in waiting patients reached a peak, while orders began for the fellow eye. In addition to NIDEC CORPORATION’s sales activities, the Company began a new initiative allocating its own resources to physician education and identifying potential patients. - FY2024RestatedAnnual report
「Revenue from the ophthalmology field and other businesses during the fiscal year was ¥174.67 million, down 15.7% year on year. Although revenue in the ophthalmology field had expanded following the launch of Ocural after Nepic, revenue struggled to grow as transplantations in waiting patients who were candidates at core facilities reached a peak. Meanwhile, as a new development, orders began to be received for the fellow eye of patients with bilateral disease who had received Ocural transplantation in one eye.」
Revenue in the ophthalmology field declined 15.7% year on year as transplantations in waiting patients at core facilities reached a peak, while orders began for the fellow eye of bilateral patients. - FY2024-Q3Transplantations in waiting patients at core facilities reached a peak, and orders for the second eye began.Annual report
「Revenue from the ophthalmology field and other businesses during the cumulative period was ¥141.04 million, down 6.9% year on year. Although revenue in the ophthalmology field had expanded following the launch of Ocural after Nepic, transplantations in waiting patients who were candidates for Ocural at core facilities reached a peak. As a new development, orders began to be received for the second eye of bilateral patients who had received Ocural transplantation in one eye.」
For Ocural, transplantations in waiting patients at core facilities reached a peak, and revenue from the ophthalmology field and other businesses declined 6.9% year on year. Meanwhile, orders began for the second eye of bilateral patients who had already received transplantation in one eye. - FY2024-Q2Revenue declined as demand at core facilities reached a peak, while orders from new facilities remained firm.Annual report
「Revenue from the ophthalmology field and other businesses during the cumulative period was ¥100.52 million, down 2.8% year on year. Although revenue in the ophthalmology field had expanded following the launch of Ocural after Nepic, orders from core facilities have slowed somewhat as transplantations in candidate patients reached a peak. Meanwhile, orders from new facilities have remained firm, and the Company will continue promoting Japan’s first regenerative medicine treatment in the ophthalmology field to corneal specialists nationwide.」
For Ocural, transplantations in candidate patients at core facilities reached a peak, and revenue from the ophthalmology field and other businesses declined 2.8% year on year. The Company states that orders from new facilities remained firm. - FY2024-Q1AdvancedAnnual report
「Revenue from the ophthalmology field and other businesses during the cumulative period was ¥55.7 million, up 83.8% year on year. Following the launch of Ocural, sales in the ophthalmology field increased substantially. In cooperation with NIDEC CORPORATION, which is responsible for sales, the Company is working to raise product awareness among general ophthalmologists at major conferences and disseminate information on treatment outcomes, while giving concrete form to initiatives to educate potential patients directly about treatment, with the aim of expanding revenue.」
Following the launch of Ocural, revenue in the ophthalmology field increased 83.8% year on year. The Company is giving concrete form to initiatives with NIDEC CORPORATION to disseminate information at major conferences and educate potential patients. - FY2023-Q3AdvancedAnnual report
「Revenue from the ophthalmology field and other businesses during the cumulative period was ¥151.5 million, up 156.1% year on year. Following Nepic, sales of Ocural were launched and revenue grew steadily. The Company also worked to raise product awareness by holding luncheon seminars at major ophthalmology conferences in cooperation with NIDEC CORPORATION, which is responsible for sales.」
Sales of Ocural, which followed Nepic, progressed, and revenue from the ophthalmology field and other businesses increased 156.1% year on year. Luncheon seminars at major conferences with NIDEC CORPORATION have also continued. - FY2023-Q2AdvancedAnnual report
「Revenue from the ophthalmology field and other businesses during the cumulative period was ¥103.4 million, up 144.2% year on year. Following Nepic, sales of Ocural were launched and revenue grew steadily. The Company also worked to raise product awareness by holding luncheon seminars at major ophthalmology conferences in cooperation with NIDEC CORPORATION, which is responsible for sales.」
Following the launch of Ocural, which followed Nepic, revenue from the ophthalmology field and other businesses increased 144.2% year on year, while promotional activities through conference seminars with NIDEC CORPORATION also advanced. - FY2023-Q1AdvancedAnnual report
「Revenue from the ophthalmology field and other businesses during the cumulative period was ¥30.3 million, up 35.3% year on year. Following Nepic, sales of Ocural were launched, and orders were received from medical institutions that had completed preparations for its use. The Company also worked to raise product awareness by holding luncheon seminars at major ophthalmology conferences in cooperation with NIDEC CORPORATION, which is responsible for sales.」
Following the launch of Ocural, orders were received from medical institutions that had completed preparations for its use, and sales and promotional activities, including conference seminars with NIDEC CORPORATION, are under way. Revenue from the ophthalmology field and other businesses increased 35.3% year on year. - FY2022-Q1AdvancedAnnual report
「During the cumulative first-quarter period, the Company received multiple orders for Nepic, which was included in national health insurance coverage in June 2020, and transplantations were performed.」
For the autologous cultured corneal epithelium Nepic, the Company progressed from receiving the first order and completing transplantation in the first case after inclusion in national health insurance coverage to receiving multiple orders and performing transplantations. - FY2021-Q3AdvancedAnnual report
「During the third quarter, the Company received the first order for Nepic, which was covered by national health insurance in June 2020, and completed transplantation in the first case. By combining the Company’s accumulated experience and expertise in the manufacture and marketing of regenerative medicine products with NIDEC CORPORATION’s strong network in the ophthalmology field, the Company was able to achieve the first transplantation smoothly in a short period. The Company will continue working with NIDEC CORPORATION to promote the first regenerative medicine product in Japan in the ophthalmology field.」
For the autologous cultured corneal epithelium Nepic, the Company received the first order after its inclusion in national health insurance coverage and reached the concrete post-commercialisation milestone of completing transplantation in the first case. - FY2021-Q2RestatedAnnual report
「Nepic, the autologous cultured corneal epithelium that obtained marketing approval in March 2020, became covered by national health insurance from 1 June. The Company is advancing sales activities in cooperation with NIDEC CORPORATION, which is responsible for sales. The Company aims to promote the first regenerative medicine product in Japan in the ophthalmology field.」
Following Nepic’s approval and inclusion in national health insurance coverage, sales and promotional activities in cooperation with NIDEC CORPORATION have continued. - FY2020AchievedAnnual report
「This product obtained marketing authorization in March 2020 for the treatment of limbal stem cell deficiency, became covered by national health insurance in June of the same year, and became the first regenerative medicine product in Japan in the ophthalmology field.」
The target of obtaining approval following the clinical trial and application for approval of the autologous cultured corneal epithelium was achieved in March 2020, and the product became covered by national health insurance in June. - FY2020-Q3RestatedAnnual report
「For the autologous cultured corneal epithelium (development name: EYE-01M), for which an application for marketing approval was submitted in March 2019, the Company continues to diligently respond to the authorities’ questions concerning the application. Preparations for an application for marketing approval of the autologous cultured oral mucosal epithelium (development name: COMET01) are also under way.」
Responses to the authorities’ questions following EYE-01M’s application for approval are ongoing, while preparations for COMET01’s application for approval are continuing. - FY2020-Q2RestatedAnnual report
「For the autologous cultured corneal epithelium (development name: EYE-01M), for which an application for marketing approval was submitted in March 2019, the Company is diligently responding to the authorities’ questions concerning the application. For the autologous cultured oral mucosal epithelium (development name: COMET), preparations for an application for marketing approval are under way.」
Responses to the authorities’ questions following EYE-01M’s application for approval are ongoing, while preparations for COMET’s application for approval are continuing. - FY2020-Q1RestatedAnnual report
「For the autologous cultured corneal epithelium (development name: EYE-01M), for which an application for marketing approval was submitted in March 2019, the Company is responding as appropriate to the authorities’ questions concerning the application. For the autologous cultured oral mucosal epithelium (development name: COMET), preparations for an application for marketing approval are under way.」
Responses to the authorities’ questions following the application for marketing approval of EYE-01M are ongoing, while preparations for COMET’s application for approval are continuing. - FY2019AdvancedAnnual report
「In March of the same year, the Company submitted an application for marketing approval of the autologous cultured corneal epithelium (development name: EYE-01M), which had been developed under contract from NIDEC CORPORATION. It was the first such application in Japan for a regenerative medicine product in the ophthalmology field.」
The autologous cultured corneal epithelium progressed from the clinical trial and application-preparation stage to the application-submission stage for marketing approval. - FY2019-Q3RestatedAnnual report
「In addition, preparations for applications for marketing approval of the autologous cultured corneal epithelium and autologous cultured oral mucosal epithelium progressed steadily.」
Preparations for applications for marketing approval of the autologous cultured corneal epithelium and autologous cultured oral mucosal epithelium are ongoing. - FY2019-Q2RestatedAnnual report
「In addition, preparations for applications for marketing approval of the autologous cultured corneal epithelium and autologous cultured oral mucosal epithelium progressed steadily.」
Preparations for applications for marketing approval of the autologous cultured corneal epithelium and autologous cultured oral mucosal epithelium are ongoing. - FY2018-Q3AdvancedAnnual report
「Clinical trials are being conducted for autologous cultured corneal epithelium, which is being developed under contract from NIDEK, and autologous cultured oral mucosal epithelium, for which development services have been undertaken from Osaka University, for the indication of limbal stem cell deficiency. The Company is preparing to file applications for marketing approval, including compiling clinical trial data.」
The clinical trial of the autologous cultured corneal epithelium is ongoing, and preparations for the application for marketing approval, including compiling the clinical trial data, are under way. - FY2018-Q2RestatedAnnual report
「For the autologous cultured corneal epithelium being developed under contract from NIDEC CORPORATION, a follow-up clinical trial was conducted while a clinical trial was under way for the indication of limbal stem cell deficiency.」
Clinical and follow-up trials of the autologous cultured corneal epithelium being developed under contract from NIDEC CORPORATION are ongoing. - FY2018-Q1RestatedAnnual report
「The company continued a follow-up clinical trial while conducting the clinical trial for autologous cultured corneal epithelium developed under commission from NIDEK for the indication of unilateral corneal epithelial stem cell deficiency.」
The company continues the clinical trial and follow-up clinical trial for autologous cultured corneal epithelium commissioned by NIDEK. - FY2017-Q2RestatedAnnual report
「Autologous cultured corneal epithelium has been undergoing clinical trials since October 2014 for the indication of unilateral corneal epithelial stem cell deficiency, under the designation of an orphan regenerative medical product. Development of the product is being commissioned by NIDEK, and grants from the Japan Agency for Medical Research and Development (AMED) are also being used to conduct the clinical trials.」
The company continues the clinical trial for autologous cultured corneal epithelium commissioned by NIDEK and is also using AMED grants. - FY2017-Q1AdvancedAnnual report
「“Characterisation of cultured corneal epithelial sheets using corneal epithelial cells and conduct of a company-sponsored clinical trial.” We are proceeding with the commercialisation of autologous cultured corneal epithelium, including building a system to support efficacy prediction and conducting a company-sponsored clinical trial.」
Under a commissioned research and development agreement with AMED through 31 March 2017, the company was developing a system to support efficacy prediction, conducting characterisation analysis and implementing a company-sponsored clinical trial. - FY2016First statedAnnual report
「While consulting with NIDEK, the commissioning party, on the future development policy, we will conduct the clinical trial without delay and aim to obtain approval at an early stage. We will then promptly proceed with reimbursement discussions.」
As commissioned development for NIDEK, the company has set the clinical trial for corneal epithelial stem cell deficiency, approval and reimbursement discussions as a series of objectives.