BRM421 / BRIM Biotech, China Grand Pharma - LARVOL DELTA

A Dose Regimen Study of BRM421 Ophthalmic Solution in Patients With Dry Eye Disease (clinicaltrials.gov) - P2 | N=99 | Not yet recruiting | Sponsor: BRIM Biotechnology Inc.

New P2 trial • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • 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

Assessment of the Safety and Efficacy of BRM421 Ophthalmic Solutions in Dry Eye Subjects. (clinicaltrials.gov) - P3 | N=740 | Completed | Sponsor: BRIM Biotechnology Inc. | Recruiting ➔ Completed

Trial completion • Dry Eye Disease • Ophthalmology

Assessment of the Safety and Efficacy of BRM421 Ophthalmic Solutions in Dry Eye Subjects. (clinicaltrials.gov) - P3 | N=732 | Recruiting | Sponsor: BRIM Biotechnology Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Dry Eye Disease • Ophthalmology

Assessment of the Safety and Efficacy of BRM421 Ophthalmic Solutions in Subjects With Dry Eye. (clinicaltrials.gov) - P3 | N=732 | Not yet recruiting | Sponsor: BRIM Biotechnology Inc.

New P3 trial • Dry Eye Disease • Ophthalmology

Safety and Efficacy of BRM421 for Dry Eye Syndrome Treatment (clinicaltrials.gov) - P2/3; N=220; Completed; Sponsor: BRIM Biotechnology Inc.; Recruiting ➔ Completed

Clinical • Trial completion • Dry Eye Disease • Ophthalmology

[VIRTUAL] Topical BRM421 Ophthalmic Solution improves signs and symptoms of moderate to severe dry eye patients in clinical trials (ARVO 2021) - "Both clinical studies confirmed consistent early onset of BRM421 treatment effects of sign and symptoms. The post hoc analyses showed improved efficacy in favor of BRM421 in a more severe patient population. The findings warrant further study of BRM421 Ophthalmic Solution in subjects suffering from dry eye syndrome."

Clinical • Dry Eye Disease • Ocular Inflammation • Ophthalmology

Safety and Efficacy of BRM421 for Dry Eye Syndrome Treatment (clinicaltrials.gov) - P2/3; N=200; Recruiting; Sponsor: BRIM Biotechnology Inc.; Trial primary completion date: Apr 2020 ➔ Jul 2020

Clinical • Trial primary completion date • Dry Eye Disease • Ophthalmology

A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of BRM421 for Dry Eye Syndrome (clinicaltrials.gov) - P2/3; N=200; Recruiting; Sponsor: BRIM Biotechnology Inc.

Clinical • New P2/3 trial