tavilermide (MIM-D3) / Mimetogen - LARVOL DELTA

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

Efficacy and Safety Evaluation of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye (clinicaltrials.gov) - P3 | N=642 | Completed | Sponsor: Mimetogen Pharmaceuticals USA, Inc. | Active, not recruiting ➔ Completed

Trial completion • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology

Efficacy and Safety Evaluation of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye (clinicaltrials.gov) - P3 | N=642 | Active, not recruiting | Sponsor: Mimetogen Pharmaceuticals USA, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology

Tavilermide for DED: Results of the Phase 3, Randomized, Multicenter, Double-Masked, Vehicle-Controlled MIM-728 Study (AAO 2023) - "Ocular adverse events were low and mild in severity. Conclusion Tavilermide 5% demonstrated significant improvement versus vehicle in tCFS signs of DED and symptoms in a clinically meaningful subgroup along with a favorable safety profile."

Clinical • P3 data • Dry Eye Disease • Ophthalmology

Efficacy and Safety Evaluation of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye (clinicaltrials.gov) - P3 | N=630 | Recruiting | Sponsor: Mimetogen Pharmaceuticals USA, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology

Efficacy and Safety Evaluation of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye (clinicaltrials.gov) - P3 | N=630 | Not yet recruiting | Sponsor: Mimetogen Pharmaceuticals USA, Inc.

New P3 trial • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology

Tavilermide Ophthalmic Solution for the Treatment of Dry Eye (clinicaltrials.gov) - P3; N=615; Completed; Sponsor: Mimetogen Pharmaceuticals USA, Inc.; Recruiting ➔ Completed; Trial primary completion date: Feb 2020 ➔ Jun 2020

Trial completion • Trial primary completion date • Conjunctivitis • Dry Eye Disease • Ocular Inflammation • Ophthalmology • Sjogren's Syndrome

Allergan: Q1 FY 2016 Results (Allergan) - Anticipated data from first P3 trial (NCT02665234) in dry eye disease in H2 2016

Anticipated P3 data • Dry Eye Disease • Ophthalmology

Mimetogen Pharmaceuticals completes enrollment of MIM-728 phase 3 trial for tavilermide for dry eye disease (Businesswire) - "'It is encouraging to see Mimetogen pursuing development of tavilermide, a small-molecule peptidomimetic of NGF, with a multifactorial mechanism of action that addresses many underlying pathologies of dry eye disease. Demonstration of a significant improvement in signs and symptoms would represent a major advancement for this novel therapy for dry eye disease,' said Dr. Edward Holland..."

Media quote

Tavilermide Ophthalmic Solution for the Treatment of Dry Eye (clinicaltrials.gov) - P3; N=600; Recruiting; Sponsor: Mimetogen Pharmaceuticals USA, Inc.

Clinical • New P3 trial