cyclosporine A ophthalmic gel (CsA gel) / Zhaoke Ophthalmology - LARVOL DELTA

Zhaoke Ophthalmology’s CsA Ophthalmic Gel NDA Accepted by NMPA (TipRanks) - "Zhaoke Ophthalmology Limited announced that the National Medical Products Administration of China has accepted its New Drug Application for the CsA Ophthalmic Gel, a treatment for moderate to severe dry eye disease."

China filing • Dry Eye Disease • Ophthalmology

A Study to Evaluate the Efficacy and Safety of Treatment With CsA-PG Ophthalmic Gel in Dry Eye Patients (clinicaltrials.gov) - P3 | N=396 | Not yet recruiting | Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

New P3 trial • Dry Eye Disease • Ophthalmology

FIRST PATIENT ENROLLED IN THE ADDITIONAL PHASE III CLINICAL TRIAL OF CYCLOSPORINE A (CsA) OPHTHALMIC GEL (HKEXnews) - "The Board of the Company is pleased to announce that the first patient was enrolled in the Phase III clinical trial of one of the Company’s drug candidates, Cyclosporine (CsA) Ophthalmic Gel, for the treatment of moderate to severe dry eye disease ('DED'), on April 3, 2025. The Phase III clinical trial is a multi-center, randomized, double-blinded and placebo controlled study on the efficacy and safety of CsA Ophthalmic Gel in patients with moderate to severe dry eye. Led by Professor Zuguo Liu, Director of Eye Institute of Xiamen University, the trial will involve 25 centres and enroll a total of 360 patients."

Trial status • Dry Eye Disease