Santen Pharmaceutical ((SNPHY)) announced an update on their ongoing clinical study.
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Study Overview: Santen Pharmaceutical is conducting a Phase III study titled A Phase III Study Including a Single-Arm, Open-Label, Multi-Dose PK Study Cohort and a Randomized, Evaluator-Masked, Active Drug Controlled, Parallel Group, Multicenter, Bridging Study Cohort With a Long-term Follow-up Phase Assessing the Efficacy and Safety of DE-117B Eye Drops in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension in China. The study aims to evaluate the efficacy and safety of DE-117B eye drops in treating primary open angle glaucoma (POAG) and ocular hypertension (OHT) in Chinese patients, highlighting its significance in potentially improving treatment outcomes for these conditions.
Intervention/Treatment: The study tests DE-117B eye drops, an experimental drug administered at a concentration of 0.002%, intended to lower intraocular pressure in patients with POAG and OHT. Latanoprost, a 0.005% eye drop, serves as the active comparator.
Study Design: This interventional study is randomized with a parallel assignment model. It features single masking, where the investigator is blinded. The primary purpose is treatment, focusing on the therapeutic effects of DE-117B eye drops.
Study Timeline: The study commenced on October 29, 2024, with a primary completion date yet to be announced. The last update was submitted on February 27, 2025, indicating ongoing recruitment and progress.
Market Implications: The successful development of DE-117B could enhance Santen Pharmaceutical’s market position, potentially boosting its stock value. As the study progresses, investor sentiment may be positively influenced by promising results, especially in the competitive ophthalmic treatment market.
The study is currently ongoing, with further details available on the ClinicalTrials portal.