Sentinel (cenegermin-bkbj) / Dompe - LARVOL DELTA

Corneal Nerves After Treatment With Cenegermin (clinicaltrials.gov) - P=N/A | N=8 | Completed | Sponsor: University of California, Los Angeles | Active, not recruiting ➔ Completed | N=40 ➔ 8

Enrollment change • Trial completion • Keratitis • Ocular Inflammation • Ophthalmology

1953-2023. Seventy Years of the Nerve Growth Factor: A Potential Novel Treatment in Neurological Diseases? (PubMed, Aging Dis) - "In these instances, NGF holds promise for promoting tissue regeneration and repair. Challenges persist in addressing the complexity of neurodegenerative pathologies for a combined therapeutic approach."

Journal • Review • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • Cardiovascular • CNS Disorders • Gene Therapies • Huntington's Disease • Movement Disorders • Musculoskeletal Diseases • Oncology • Orthopedics • Parkinson's Disease • Sarcoma • Solid Tumor • Vascular Neurology

Long-Term Therapeutic Effects of Topical Recombinant Human Nerve Growth Factor in Stage I Neurotrophic Keratitis and Retreatment Considerations (ARVO 2025) - "Purpose To evaluate the long-term therapeutic effects of topical recombinant human nerve growth factor (rhNGF; cenegermin) in patients with stage I neurotrophic keratitis (NK)...Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Keratitis • Ocular Inflammation • Ophthalmology

Trends and Insights of a Tertiary Referral Hospital for Patients with Neurotrophic Keratopathy (ARVO 2025) - "Purpose To examine the impact of the FDA approval in 2018 and subsequent use of Cenegermin 0.002% since 2019 on referral patterns for patients with neurotrophic keratopathy (NK) by comparing the initial clinical findings observed at a tertiary referral hospital...Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • Dry Eye Disease • Keratitis • Ocular Inflammation • Ophthalmology

Topical application of the HSV-1-based gene therapy vector KB801 results in sustained nerve growth factor expression in wounded murine corneas (ARVO 2025) - "The only approved therapeutic option for NK is cenegermin-bkbj, an ophthalmic solution of recombinant human NGF (rhNGF) administered six times daily for eight weeks; however, the high dosing frequency that is required due to rapid rhNGF clearance is burdensome and may lead to suboptimal treatment outcomes...Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Gene therapy • Preclinical • Keratitis • Ocular Inflammation • Ophthalmology • NGF

Topical Cenegermin-Bkbj Dramatically Resolves Neurotrophic Keratitis Associated With Pars Plana Vitrectomy. (PubMed, Ophthalmic Surg Lasers Imaging Retina) - "A 60-year-old woman with recurrent retinal detachments in the right eye after receiving the third PPV developed persistent irritation, photophobia, and worsening visual acuity due to iatrogenic NK despite lubrication, bandage contact lens, preservative-free artificial tears, restasis, and right lower lid punctal cautery over 6 weeks. This case highlights the importance of early recognition, tailored management, and the potential efficacy of Cenegermin-Bkbj in treating NK arising after retinal procedures. [Ophthalmic Surg Lasers Imaging Retina 2025;56:XX-XX.]."

Journal • Keratitis • Ocular Inflammation • Ophthalmology • Retinal Disorders

CORNEAL NEURTIZATION: A SAFE AND EFFECTIVE LONG-TERM OPTION FOR NEUROTROPHIC KERATOPATHY. (WRMC 2025) - "The study also aims to determine if use of the human recombinant nerve growth factor therapy cenegermin improves recovery in CN patients...Corneal neurotization yields more favorable outcomes in patients with a peripheral etiology of NK than patients with a central etiology. Patients undergoing corneal neurotization can experience significant improvement in corneal sensation and integrity, allowing them to taper medical therapy and obtain visually rehabilitative procedures if necessary."

Dry Eye Disease • Ophthalmology

Drug Delivery in PROSE Device as Alternative to Frequent Drop Administration in Severe Ocular Surface Disease. (PubMed, Eye Contact Lens) - "The design of the prosthetic replacement of the ocular surface ecosystem (PROSE) device allows it to serve as a novel drug delivery system. In this article, we describe the off-label administration of amphotericin B and cenegermin by instillation in the PROSE device reservoir for the treatment of Candida keratitis in the setting of a persistent epithelial defect."

Journal • Keratitis • Ocular Inflammation • Ophthalmology

REDUCO: A Study to Evaluate Safety and Efficacy of a New Formulation of Recombinant Human Nerve Growth Factor (rhNGF) Eye Drop Solution in Patients With Dry Eye Disease (clinicaltrials.gov) - P2 | N=317 | Completed | Sponsor: Dompé Farmaceutici S.p.A | Active, not recruiting ➔ Completed

Trial completion • Dry Eye Disease • Ophthalmology

IMAGO: Open-label Trial to Evaluate Efficacy and Safety of rhNGF on Corneal Thickness Via AS-OCT in Neurotrophic Keratitis (clinicaltrials.gov) - P4 | N=0 | Withdrawn | Sponsor: Dompé Farmaceutici S.p.A | N=17 ➔ 0 | Trial completion date: Jun 2025 ➔ Nov 2024 | Active, not recruiting ➔ Withdrawn | Trial primary completion date: Jun 2025 ➔ Nov 2024

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Dry Eye Disease • Keratitis • Ocular Inflammation • Ophthalmology

Corneal Nerves After Treatment With Cenegermin (clinicaltrials.gov) - P=N/A | N=40 | Active, not recruiting | Sponsor: University of California, Los Angeles | Recruiting ➔ Active, not recruiting

Enrollment closed • Keratitis • Ocular Inflammation • Ophthalmology

Effects of mesenchymal stromal cells and human recombinant Nerve Growth Factor delivered by bioengineered human corneal lenticule on an innovative model of diabetic retinopathy. (PubMed, Front Endocrinol (Lausanne)) - "Overall, we found for the first time that hAFSCs and rhNGF were able to modulate the molecular mechanisms involved in DR and that bioengineered hCLs represents a promising ocular drug delivery system of hAFSCs and rhNGF for eye diseases treatment. In addition, results demonstrated that porcine neuroretinal explants treated with HG is a useful model to reproduce ex vivo the DR pathophysiology."

IO biomarker • Journal • Stroma • CNS Disorders • Diabetes • Diabetic Retinopathy • Metabolic Disorders • Ophthalmology • Retinal Disorders • BAX • BCL2 • GFAP • NFKB1 • NOS2 • TUBB3

REDUCO: A Study to Evaluate Safety and Efficacy of a New Formulation of Recombinant Human Nerve Growth Factor (rhNGF) Eye Drop Solution in Patients With Dry Eye Disease (clinicaltrials.gov) - P2 | N=291 | Active, not recruiting | Sponsor: Dompé Farmaceutici S.p.A | Recruiting ➔ Active, not recruiting

Enrollment closed • Dry Eye Disease • Ophthalmology

The Recombinant Human Nerve Growth Factor for Pediatric Neuropathic Keratopathy: Focus on Corneal Scarring, Amblyopia and Outcomes (AAO 2024) - "Purpose To evaluate the impact of topical recombinant human nerve growth factor (rhNGF, cenegermin) on corneal scarring and amblyopia in pediatric patients with neurotrophic keratitis (NK)...Conclusion While rhNGF reduces scar size, it does not improve BCVA or correct refractive errors that increase the risk of amblyopia. Earlier treatment of pediatric NK before the onset of scarring may be needed to prevent amblyopia."

Clinical • Astigmatism • Corneal Abrasion • Keratitis • Ocular Inflammation • Ophthalmology

Clinical-grade intranasal NGF fuels neurological and metabolic functions of Mecp2-deficient mice. (PubMed, Brain) - "The well-known deficiency of several neurotrophins and growth factors, together with the positive effects exerted by Trofinetide, a synthetic analogue of insulin-like growth factor 1, in Rett patients and in mouse models of Mecp2 deficiency, prompted us to investigate the therapeutic potential of nerve growth factor...Furthermore, GO analyses indicated that NGF exerted the expected improvement in neuronal maturation. We conclude that intranasal administration of rhNGF is a non-invasive and effective route of administration for the treatment of Rett syndrome and possibly for other neurometabolic disorders with overt mitochondrial dysfunction."

Journal • Preclinical • CNS Disorders • Developmental Disorders • Epilepsy • Mental Retardation • Metabolic Disorders • Movement Disorders • Psychiatry • IGF1

DEFENDO Long Term Follow-up Study in Stage 1 NK Patients (clinicaltrials.gov) - P=N/A | N=24 | Completed | Sponsor: Dompé Farmaceutici S.p.A | Recruiting ➔ Completed | N=37 ➔ 24 | Trial completion date: Sep 2024 ➔ Apr 2024 | Trial primary completion date: Sep 2024 ➔ Apr 2024

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Keratitis • Ocular Inflammation • Ophthalmology

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

Role Of Topical Cenegermin In The Management Of Neurosurgically Induced Neurotrophic Keratitis (ESCRS 2024) - "She was treated with moxifloxacin eye drops 4 times, preservative-free artificial tears, cyclosporine 0.05% eye drops, lubricant ointment, autologous serum drops and self-retained amniotic membranes. The safety and efficacy of cenegermin has been successfully tested in clinical trials in patients with moderate and severe NK. This case is the report of our first experience with cenegermin 20 μg/ml in the treatment od NK, which has shown to be effective and well tolerated in the healing of corneal ulcer and improvement of VA and corneal sensitivity in a patient with neurosurgically induced NK."

Keratitis • Ocular Inflammation • Ophthalmology

Enhancing Corneal Healing In Neurotrophic Keratitis: Evaluating The Impact Of Post-Operative Cenegermin Following Penetrating Keratoplasty (ESCRS 2024) - "Another advantage lies in potentially reducing healthcare costs on repeat PK procedures. Further studies are required to substantiate these anecdotal findings on a larger and more meaningful scale."

Dry Eye Disease • Keratitis • Ocular Inflammation • Ophthalmology

The use of rh-NGF in the management of neurotrophic keratopathy. (PubMed, Front Ophthalmol (Lausanne)) - "Different clinical trials have demonstrated the safety and efficacy of topical cenegermin in patients with moderate to severe neurotrophic keratitis. In this review, we report the literature on clinical results regarding the treatment of NK with cenegermin since its approval by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in 2017 and 2018, respectively."

Journal • Review • Dry Eye Disease • Keratitis • Ocular Inflammation • Ophthalmology

Recombinant human nerve growth factor (cenegermin) for moderate-to-severe dry eye: phase II, randomized, vehicle-controlled, dose-ranging trial. (PubMed, BMC Ophthalmol) - P2 | "Cenegermin was well tolerated and although this study did not meet its primary endpoint, significant improvement in patient-reported symptoms of dry eye was observed through follow-up. Larger studies evaluating cenegermin in patients with DED are warranted."

Clinical • Journal • P2 data • Dry Eye Disease • Keratitis • Ocular Inflammation • Ophthalmology • Pain

The History of Nerve Growth Factor: From Molecule to Drug. (PubMed, Biomolecules) - "Recent advances in the production and scientific knowledge of recombinant NGF have enabled its clinical development, and in 2018, the United States Food and Drug Administration approved cenegermin-bkbj, a recombinant human NGF, for the treatment of all stages of neurotrophic keratitis. This review traces the evolutionary path that transformed NGF from a biological molecule into a novel therapy with potential research applications beyond the eye. Special emphasis is put on the studies that advanced NGF from discovery to the first medicinal product approved to treat a human disease."

Journal • Review • Keratitis • Ocular Inflammation • Ophthalmology

Development and Characterization of a Photocrosslinkable, Chitosan-Based, Nerve Growth Factor-Eluting Hydrogel for the Ocular Surface. (PubMed, Transl Vis Sci Technol) - "Recombinant human nerve growth factor (rhNGF; cenegermin-bkbj, OXERVATE) is the first and only U.S. Food and Drug Administration-approved treatment for moderate to severe neurotrophic keratopathy...This drug delivery system has the potential to be further developed for in vivo and translational clinical applications. Az-Ch hydrogels may be used to enhance rhNGF therapy in patients with NK."

Journal • Dry Eye Disease • Ophthalmology

NGF0121: Safety and Efficacy Study on Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease (PROTEGO-1 Study) (clinicaltrials.gov) - P3 | N=104 | Completed | Sponsor: Dompé Farmaceutici S.p.A | Active, not recruiting ➔ Completed

Trial completion • Dry Eye Disease • Ophthalmology

IMAGO: Open-label Trial to Evaluate Efficacy and Safety of rhNGF on Corneal Thickness Via AS-OCT in Neurotrophic Keratitis (clinicaltrials.gov) - P4 | N=17 | Active, not recruiting | Sponsor: Dompé Farmaceutici S.p.A

New P4 trial • Dry Eye Disease • Keratitis • Ocular Inflammation • Ophthalmology