Sentinel (cenegermin-bkbj) / Dompe - LARVOL DELTA

New pharmacological and biotechnological approaches for the treatment of neurotrophic keratopathy: From growth factors to gene therapy. (PubMed, Indian J Ophthalmol) - "The introduction of recombinant human nerve growth factor (rhNGF, cenegermin) has marked the first disease-modifying pharmacological therapy for NK, providing evidence of enhanced epithelial healing and improved corneal sensitivity...The objective of this review is to offer an analysis of the management of NK in the context of recent pharmacological and biotechnological advancements in the light of current literature. This review aims to provide an integrated and pathophysiology-oriented synthesis of NK management, uniquely bridging pharmacological treatments with emerging biotechnological strategies including gene therapy, cell-based approaches, and novel drug delivery systems."

Journal • CNS Disorders • Dry Eye Disease • Gene Therapies • Ophthalmology

Use of recombinant nerve growth factor in the treatment of neurotrophic keratitis associated with ichthyosis follicularis, atrichia, and photophobia (IFAP syndrome) (PubMed, Vestn Oftalmol) - "Complete restoration of the epithelial layer and corneal sensitivity persisted two months after completion of the treatment course. The use of the drug cenegermin effectively restored the epithelium and corneal sensitivity in long-persisting corneal erosions in a child with ichthyosis follicularis, atrichia, and photophobia (IFAP syndrome)."

Journal • Atopic Dermatitis • CNS Disorders • Corneal Abrasion • Dermatology • Immunology • Keratitis • Ocular Inflammation • Ophthalmology • Pain • Vitiligo

Comparison of Nerve Growth Factor with Fetal Bovine Serum for Promoting Closure of Defects in Corneal Epithelial Cell Layers. (PubMed, Biomedicines) - "The drug, Oxervate™, whose active principle is recombinant human nerve growth factor (NGF), has been shown to promote healing of the corneal epithelial layer in NK...They also show that FBS is more effective than NGF alone in producing this effect. Since the therapeutic activity of NGF in NK may be partly mediated through a direct action on corneal epithelial cells, identifying the factors in FBS that promote corneal healing might lead to more effective treatments for NK."

Journal • Keratitis • Ocular Inflammation • Ophthalmology

Therapeutic efficacy of cenegermin in the management of neurotrophic keratitis: a systematic review and meta-analysis of randomized controlled trials. (PubMed, Ther Adv Ophthalmol) - "Larger, independently funded trials with longer follow-up are warranted to confirm these findings and to establish its position within the treatment algorithm. PROSPERO CRD420251103148."

Journal • Retrospective data • Anesthesia • Keratitis • Ocular Inflammation • Ophthalmology

The Neuro-Immune-Epithelial Axis in Dry Eye: From Pathogenic Crosstalk to Neuromodulatory Therapies. (PubMed, Exp Eye Res) - "Varenicline nasal spray and acoltremon engage reflex or sensory tear pathways where approved; motugivatrep illustrates region-specific TRPV1 translation in Japan; diquafosol and rebamipide are epithelial/mucin-supportive therapies with indirect axis relevance; and cenegermin remains primarily a neurotrophic keratitis therapy with restricted relevance to selected DED phenotypes. Neuropeptide-specific targets, availability-limited device stimulation, and direct nerve-regenerative claims for photobiomodulation remain preliminary. This framework may support mechanism-based stratification and rational adjunctive therapy without replacing established DED classifications."

Journal • Review • Dry Eye Disease • Immunology • Inflammation • Keratitis • Ocular Inflammation • Ophthalmology • Pain • TRPV1

Corneal nerve regeneration: treatments and monitoring approaches. (PubMed, Ann Med) - "Corneal nerve treatments require an in-depth understanding of neurotrophic mediators and nerve function, with current key treatments, such as cenegermin, targeting one of the most well-studied pathways...By leveraging advanced imaging modalities such as in vivo confocal microscopy, clinicians can detect nerve injury before symptom onset, enabling critical early intervention. Furthermore, integrating emerging regenerative therapies shifts the clinical paradigm from palliative symptom management to active restoration of corneal nerve integrity."

Journal • Review • Keratitis • Ocular Inflammation • Ophthalmology

Neurotrophic Keratitis Associated With Telisotuzumab Vedotin: A Case Report. (PubMed, Cornea) - "This report describes the first documented case of NK associated with Teliso-V therapy. The temporal association between Teliso-V exposure, bilateral corneal hypoesthesia, persistent epithelial defects, and concurrent peripheral neuropathy suggests a potential neurotoxic mechanism related to the drug's monomethyl auristatin E payload. Clinicians should maintain a high index of suspicion for NK in patients receiving ADCs who present with painless visual decline and corneal epithelial disease. Early diagnosis and prompt treatment with cenegermin may facilitate corneal healing and prevent vision-threatening complications."

Journal • Keratitis • Lung Cancer • Non Small Cell Lung Cancer • Ocular Inflammation • Oncology • Ophthalmology • Pain • Peripheral Neuropathic Pain • Solid Tumor • Transplantation • MET

Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) (clinicaltrials.gov) - P3 | N=272 | Recruiting | Sponsor: Dompé Farmaceutici S.p.A | Not yet recruiting ➔ Recruiting

Enrollment open • Ocular Inflammation • Ophthalmology • Optic Neuritis

An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED (clinicaltrials.gov) - P3 | N=150 | Recruiting | Sponsor: Dompé Farmaceutici S.p.A | Not yet recruiting ➔ Recruiting

Enrollment open • Ophthalmology

Recombinant Human Nerve Growth Factor in Pediatric Neuropathic Keratopathy: A Focus on Corneal Opacities, Amblyopia, and Visual Outcomes. (PubMed, Cornea) - "Topical rhNGF was effective and well tolerated in pediatric NK, producing rapid epithelial healing and qualitative improvement in corneal opacity appearance. Limited visual recovery likely reflects preexisting central stromal scarring and amblyopia, emphasizing the importance of early NK recognition and timely rhNGF initiation to preserve visual potential during childhood visual development and long-term clinical decision making globally care."

Journal • Astigmatism • CNS Disorders • Corneal Abrasion • Dry Eye Disease • Ophthalmology • Pediatrics

Acute Calcific Band Keratopathy After Cenegermin Treatment for Neurotrophic Keratitis. (PubMed, Cornea) - "BK was observed after cenegermin use. Herein, we report a series of 5 cases, which occurred at the same institution. Ethylenediaminetetraacetic acid chelation therapy had variable results, with 4 out of 5 patients requiring repeated surgical intervention because of multiple recurrences of BK."

Journal • Keratitis • Ocular Inflammation • Ophthalmology

Extended Sequential Cenegermin Dosing Achieves Greater Symptomatic and Structural Outcomes In Neurotrophic Keratopathy Patients (ARVO 2026) - "The drops were well tolerated with mild side effects. These findings suggest that extending cenegermin treatment may provide better relief and healing for patients with severe dry eye and NK compared with a single standard course."

Clinical • Dry Eye Disease • Ophthalmology

Risk Factors for Recurrence of Neurotrophic Keratopathy After Cenegermin Treatment (ARVO 2026) - "In this cohort, neither ocular surface comorbidities nor functional nerve recovery were statistically predictive of recurrence, suggesting that recurrence may be driven by intrinsic neurodegenerative factors rather than concurrent ocular surface disease. While repeat treatment courses are effective for re-inducing epithelial healing, the high rate of subsequent recurrence in these cases warrants further investigation into optimal long-term management strategies."

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

Matrix Metalloproteinase-9 expression in tear film decreases after treatment of neurotrophic keratitis with recombinant human nerve growth factor: a biomarker evaluation study (ARVO 2026) - "These patients were then treated with Cenegermin-bkbj, six (6) times daily (q2hr) for eight (8) weeks...This suggests that MMP9s may serve as a supplemental biomarker for monitoring treatment response and ocular surface stability in NK. Larger studies with a control cohort are warranted to validate these findings."

Biomarker • Keratitis • Ocular Inflammation • Ophthalmology • MMP9

Structural and functional changes in corneal innervation after treatment with cenegermin: an in vivo confocal microscopy analysis (ARVO 2026) - P | "These findings show that the cornea heals in several different ways at once, and not all responses follow the same timeline. Understanding these patterns may help guide expectations for recovery and improve how we monitor treatment in the future."

Preclinical • Dry Eye Disease • Ophthalmology

Effect of recombinant human Nerve Growth factor in the management of Limbal Stem Cell Deficiency (ARVO 2026) - "Purpose To evaluate the effect of nerve growth factor (NGF)–based therapy in managing patients with limbal stem cell deficiency (LSCD) Methods A Retrospective cohorot study was conducted using electronic medical records review of LSCD patients who completed the cycle of Cenegermin-bkbj 0.002% (1 drop 6 times a day for 8 weeks) of from 2018 – 2025 ((IRB #10-1601)...NGF treatment was associated with significant improvement in visual acuity. Larger prospective studies are necessary to further investigate the effect of NGF in managing LSCD."

Glaucoma • Ophthalmology

Biological stability assessment of human corneal lenticules bioengineered with rhNGF-microparticles under long-term storage conditions (ARVO 2026) - "These results show that our NGF-loaded hCL are stable, long-lasting, and potentially ready to use whenever needed. This brings us closer to creating an accessible, long-term treatment option for people with corneal nerve damage and related eye disorders."

Ophthalmology

NGF-PCED-301: An efficacy and safety study of cenegermin ophthalmic solution compared with vehicle in the treatment of PCED (clinicaltrialsregister.eu) - P2/3 | N=25 | Not yet recruiting | Sponsor: Dompe' Farmaceutici S.p.A.

New P2/3 trial • Ophthalmology

Neurotrophic Keratopathy: Current Concepts, Management, and Emerging Treatments. (PubMed, Cornea) - "NK is a chronic and potentially progressive disease that requires vigilance to monitor for future progression even after periods of apparent stability. As in other serious chronic conditions without a cure, earlier intervention in this challenging disease may obviate future decompensation and visually significant sequelae."

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

The Efficacy and Safety of Recombinant Human Nerve Growth Factor (rhNGF) in Patients With Dry Eye Disease: A Systematic Review and Meta-analysis. (PubMed, Int Ophthalmol) - "rhNGF shows promise for improving tear production in patients with dry eye disease, as demonstrated by significant improvement in Schirmer test results. However, evidence for broader clinical efficacy remains limited, with other outcomes showing non-significant or heterogeneous findings. Current data are based on a small number of trials, indicating the need for larger, well-designed studies to clarify the therapeutic role and safety profile of rhNGF in dry eye disease."

Clinical • Journal • Retrospective data • Review • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology • Sjogren's Syndrome

NGF-TBI-201: Proof-of-Concept Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy Study of Intranasal Cenegermin in Adult Participants with moderate to severe Traumatic Brain Injury (TBI). (clinicaltrialsregister.eu) - P1/2 | N=98 | Not yet recruiting | Sponsor: Dompe' Farmaceutici S.p.A.

New P1/2 trial • CNS Disorders • Vascular Neurology

An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: Dompé Farmaceutici S.p.A

New P3 trial • Ophthalmology

Systematic Literature Review on the Effect of Cenegermin on Corneal Sensation and Innervation in Patients with Neurotrophic Keratopathy. (PubMed, J Ocul Pharmacol Ther) - "An 8-week course of cenegermin led to improvements in CS and CI in patients with NK, with greater relative gains observed among those patients with more severe disease. While study design heterogeneity and small sample sizes may limit the generalizability of these findings, the data support cenegermin's role in promoting corneal nerve regeneration."

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

Observation of Corneal Nerve Regeneration after Oxervate Treatment with Confocal Microscopy - A Clinical Case. (PubMed, Klin Monbl Augenheilkd) - No abstract available

Journal

NGF-CP-201: Intranasal Cenegermin in Pediatric Participants with Spastic Cerebral Palsy. (clinicaltrialsregister.eu) - P1/2 | N=60 | Recruiting | Sponsor: Dompe' Farmaceutici S.p.A. | Not yet recruiting ➔ Recruiting

Enrollment open • Cerebral Palsy • CNS Disorders • Pediatrics