SHJ002 / Sunhawk Vision Biotech - LARVOL DELTA

Efficacy and Safety of SHJ002 Ophthalmic Solution in the Treatment of Corneal Erosion in Sjogren's Patients (clinicaltrials.gov) - P2 | N=116 | Completed | Sponsor: Sunhawk Vision Biotech, Inc. | Active, not recruiting ➔ Completed | Trial primary completion date: Jan 2025 ➔ Apr 2025

Trial completion • Trial primary completion date • Corneal Abrasion • Immunology • Ophthalmology • Sjogren's Syndrome

A Randomized Phase-II Trial to Assess Efficacy, Safety and Tolerability of anti-microRNA-328 Ophthalmic Solution for Treatment of Dry Eye Disease (ARVO 2025) - "We developed anti-miRNA-328 eye drops called SHJ002...We developed a novel RNA therapy using eye drops to treat the disease. The human clinical study showed that our novel eye drops improved both symptoms and signs of the disease."

Clinical • P2 data • Dry Eye Disease • Ophthalmology • MIR328

A Study of SHJ002 Sterile Ophthalmic Solution for Myopia Control (clinicaltrials.gov) - P2 | N=144 | Recruiting | Sponsor: Sunhawk Vision Biotech, Inc. | Not yet recruiting ➔ Recruiting | Initiation date: Aug 2024 ➔ Jan 2025

Enrollment open • Trial initiation date • Ophthalmology

Efficacy and Safety of SHJ002 Ophthalmic Solution in the Treatment of Corneal Erosion in Sjogren's Patients (clinicaltrials.gov) - P2 | N=122 | Active, not recruiting | Sponsor: Sunhawk Vision Biotech, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Corneal Abrasion • Immunology • Ophthalmology • Sjogren's Syndrome

Quintessence of currently approved and upcoming treatments for dry eye disease. (PubMed, Graefes Arch Clin Exp Ophthalmol) - "Currently, the US Food and Drug Administration (FDA)-approved medical treatments for treatment of DED include cyclosporine formulations (RESTASIS® [cyclosporine 0.05% ophthalmic emulsion], VEVYE® [cyclosporine 0.1% ophthalmic solution], and CEQUA™ [cyclosporine 0.09% ophthalmic solution]), XIIDRA® (lifitegrast), a leukocyte function-associated antigen-1 (LFA-1)/intracellular adhesion molecule-1(ICAM-1) inhibitor, EYSUVIS™ (loteprednol etabonate ophthalmic suspension 0.25%), a corticosteroid, and MIEBO™ (perfluorohexyloctane ophthalmic solution), a semifluorinated alkane. TYRVAYA™ (varenicline solution nasal spray), a cholinergic agonist, is another formulation approved for the treatment of the signs and symptoms of DED...Cyclosporine formulations TJO-087 (cyclosporine A nanoemulsion 0.08%), SCAI-001 eye drops (cyclosporine 0.01%, 0.02%) are being evaluated against RESTASIS® and other approved treatments. The potential treatments being assessed include..."

Journal • Review • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology • Sjogren's Syndrome • ICAM1

Safety and Tolerability of Anti-microRNA-328 Ophthalmic Solution, SHJ002, in Pediatric Subjects: First-in-Human Clinical Study. (PubMed, Clin Ther) - P1 | "SHJ002 is a novel microRNA therapy that uses eye drop instillation. SHJ002 ophthalmic solution is generally safe and tolerable, which warrants further investigations in Phase II and III trials."

Journal • P1 data • Keratitis • Ocular Inflammation • Ophthalmology • Pediatrics • MIR328

A Study of SHJ002 Sterile Ophthalmic Solution for Myopia Control (clinicaltrials.gov) - P2 | N=144 | Not yet recruiting | Sponsor: Sunhawk Vision Biotech, Inc.

New P2 trial • Ophthalmology

Efficacy and Safety of SHJ002 Ophthalmic Solution in the Treatment of Corneal Erosion in Sjogren's Patients (clinicaltrials.gov) - P2 | N=122 | Recruiting | Sponsor: Sunhawk Vision Biotech, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Corneal Abrasion • Immunology • Ophthalmology • Sjogren's Syndrome

Efficacy and Safety of SHJ002 Ophthalmic Solution in the Treatment of Corneal Erosion in Sjogren's Patients (clinicaltrials.gov) - P2 | N=122 | Not yet recruiting | Sponsor: Sunhawk Vision Biotech, Inc.

New P2 trial • Corneal Abrasion • Immunology • Ophthalmology • Sjogren's Syndrome

Phase II Study of SHJ002 Sterile Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease (clinicaltrials.gov) - P2 | N=85 | Completed | Sponsor: Dreamhawk Vision Biotech, Inc. | Recruiting ➔ Completed

Trial completion • Dry Eye Disease • Ophthalmology

Phase II Study of SHJ002 Sterile Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease (clinicaltrials.gov) - P2 | N=116 | Recruiting | Sponsor: Dreamhawk Vision Biotech, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Dry Eye Disease • Ophthalmology

Phase II Study of SHJ002 Sterile Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease (clinicaltrials.gov) - P2 | N=116 | Not yet recruiting | Sponsor: Dreamhawk Vision Biotech, Inc.

New P2 trial • Dry Eye Disease • Ophthalmology