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Sunhawk Vision submitted the request to U.S. FDA for Orphan Drug Designation (ODD) for SHJ002 ophthalmic solution in treating recurrent corneal erosion in patients with Sjogren’s syndrome.

The eye drop SHJ002 for the treatment of dry eye disease has completed the submission of the Investigational New Drug (IND) application for phaseIII clinical trials to the U.S. FDA.

Sunhawk Vision received the approval of Japanese patent for the company’s novel eye drops, SHJ002, in treating ocular surface diseases (including dry eye disease).

Sunhawk Vision has signed a contract with a U.S. pharmaceutical company with 30 years of manufacturing experience and is scheduled to manufacture clinical trial ophthalmic solution in the United States in August 2025.

The clinical data on the Phase-II trial for corneal erosion in patients with Sjogren’s syndrome (NCT06381986) were locked on May 5, 2025. The data were unblinded and under statistical analysis.

Sunhawk Vision has completed all subject assessments in its Phase II clinical trial evaluating the treatment of corneal erosion in patients with Sjogren’s syndrome.

Sunhawk Vision has been registration as an Emerging Stock approved by the Taipei Exchange (OTC) Trading Center, meanwhile trading will commence from March 10, 2025.