TLG-001 Pivotal Verification Clinical Trial and Medical Device Approval
First written in FY2022. 7 of 15 entries say "Advanced", first in FY2023-Q1. Latest entry: 2026-08-19.
No other company in this theme has enough history to compare yet.
- FY2026WorsenedAnnual report
「Although the primary endpoint was not met in the efficacy analysis, a subgroup analysis limited to subjects with short outdoor activity times found a statistically significant difference in the TLG-001 group. Based on these results, we are reconsidering the target patient population and evaluation methods and considering conducting an additional trial in China.」
The domestic confirmatory clinical trial has been completed, but the primary endpoint was not met. The plan has therefore been revised to reconsider the target patient population and evaluation methods toward a marketing application and to consider an additional trial in China. A statistically significant difference was observed in a specific subgroup. - FY2026-H1AdvancedAnnual report
「The domestic confirmatory clinical trial of the medical device TLG-001 for suppressing myopia progression progressed smoothly, and observation of the final subject was completed on 27 September, achieving Last Patient Out (LPO). Preparations for conducting a clinical trial in China, the overseas licensee's market, are also progressing.」
TLG-001 reached Last Patient Out (LPO) in the domestic confirmatory clinical trial on 27 September 2025, and preparations for a clinical trial in China also advanced. - FY2024-Q3AdvancedAnnual report
「In business development, subject enrollment in the confirmatory clinical trial of TLG-001 has been completed, while the clinical trial continues」
For TLG-001, the milestone of completing subject enrollment in the confirmatory clinical trial has been reached, while the trial itself remains ongoing. - FY2024-Q2RestatedAnnual report
「In business development, while advancing subject enrollment in the confirmatory clinical trial of TLG₋001,」
Subject enrollment in the confirmatory clinical trial of TLG-001 is ongoing. No new milestone regarding trial completion or approval is disclosed. - FY2024-Q1RestatedAnnual report
「We are also continuing to enroll subjects in the confirmatory clinical trial for the medical device TLG-001, which is being developed to suppress myopia progression using violet-light technology.」
Subject enrollment in the confirmatory clinical trial of TLG-001 is ongoing. No new milestone regarding trial completion or approval is disclosed. - FY2023RestatedAnnual report
「Since 2019, we have conducted a 6-month exploratory clinical trial with a target of 40 cases (20 in the test-device group and 20 in the control-device group), confirming the safety of violet light. Based on these results, we have been conducting the final confirmatory clinical trial (*12) since June 2022, with a view to obtaining marketing approval for the medical device.」
The filing states that the confirmatory clinical trial of TLG-001 is ongoing. Its commencement had already been reported as progress, and this filing discloses no new milestone such as completion or approval. - FY2023-Q2RestatedAnnual report
「Continuation of the confirmatory clinical trial for the medical device TLG-001, which is being developed to suppress myopia progression using violet-light technology」
The company states that the confirmatory clinical trial of TLG-001 is ongoing, but discloses no new milestones such as commencement or completion. - FY2023-Q1AdvancedAnnual report
「We have also commenced a confirmatory clinical trial for the medical device TLG-001, which is being developed to suppress myopia progression using violet-light technology.」
The confirmatory clinical trial of TLG-001 planned for approval has actually commenced. - FY2022First statedAnnual report
「Since 2019, we have conducted a 6-month exploratory clinical trial with a target of 40 cases (20 in the test-device group and 20 in the control-device group), confirming the safety of violet light. Based on these results, we planned to conduct a final confirmatory clinical trial from the fiscal year ending March 2023 onward, with a view to obtaining marketing approval for the medical device.」
Following confirmation of safety in the exploratory clinical trial, a confirmatory clinical trial for approval was planned from the fiscal year ending March 2023. The irradiation design of 3 hours per day at 310 μW/cm2 was also disclosed.