Neurotrofine

Dompé farmaceutici è da più di dieci anni leader nella ricerca, nello studio e nello sviluppo di terapie innovative basate sulle neurotrofine. I nostri ricercatori sono riusciti per primi al mondo a sviluppare un metodo di produzione innovativo che ha reso possibile la realizzazione del primo farmaco biotecnologico per il trattamento della cheratite neurotrofica (Neurotrophic Keratitis - NK), una rara patologia oculare corneale rara e fino al 2017 orfana di cura. L’elevato livello di innovazione portato dal nostro farmaco nel campo dell’oftalmologia è testimoniato dal riconoscimento nel 2018 da parte della FDA della “Breakthrough Therapy Designation” e, durante il percorso di registrazione, dello status di “Fast Track” e “Priority Review”.

Il nostro approccio

La nostra ricerca di un trattamento per la cheratite neurotrofica si è focalizzata sulle neurotrofine e in particolare su NGF, grazie alle evidenze scientifiche sul ruolo di questa proteina nell’omeostasi dell’epitelio corneale. Le sue caratteristiche e la potente attività biologica hanno permesso di studiare formulazioni basate su di esso e adeguate alla somministrazione topica e in concentrazioni basse, limitando così i possibili effetti collaterali.

Le difficoltà di produzione e conservazione del principio attivo e della formulazione farmaceutica adeguata al suo utilizzo terapeutico sono stati però per molto tempo ostacoli importanti allo sviluppo di un nuovo farmaco. Le più recenti conoscenze scientifiche sulla proteina hanno permesso di superare le difficoltà nello sviluppo e, allo stesso tempo, hanno aiutato a comprendere meglio gli specifici meccanismi d’azione delle neurotrofine nei vari distretti cellulari e tissutali.

Essendo proteine responsabili della crescita di diversi tipi di cellule, le neurotrofine hanno meccanismi di regolazione molto precisi che, ad esempio, vanno considerati in fase di sperimentazione in quanto legati sia alla loro attività biologica sia al possibile effetto su bersagli molecolari/cellulari indesiderati. Lo sviluppo del processo del farmaco ha avuto, tra i diversi obiettivi, quello di produrre un principio attivo stabile e un farmaco utilizzabile sia dal medico che dal paziente.

La scoperta del NGF ha valso il Premio Nobel per la Medicina alla professoressa Rita Levi Montalcini e al biochimico Stanley Cohen nel 1986, ma è solo 24 anni dopo che è iniziato il suo sviluppo terapeutico. Con l’acquisizione dei diritti per lo sviluppo, la produzione e la commercializzazione del NGF, dal 2010 la nostra ricerca si è concentrata sulla possibile prima applicazione terapeutica degli studi della senatrice a vita.

Prima di noi i tentativi di produrre questa proteina erano stati condotti in cellule eucariotiche che però non avevano mai portato a un processo efficiente e con buona resa produttiva che potesse nel tempo garantire ai pazienti l’accesso alla terapia.

Per risolvere questa sfida abbiamo seguito un approccio innovativo e ideato il primo processo biotecnologico per produrre un nuovo NGF ricombinante umano in cellule procariote – più specificamente quelle del batterio Escherichia coli – così da sfruttare l’alta resa consentita da questi microorganismi da tempo al centro delle produzioni biotech. L'NGF così è indistinguibile da quello umano ed ha caratteristiche qualitative superiori a quelle di altre proteine prodotte con altri sistemi biotech.

Questo risultato, ottenuto dopo anni di ricerca e studi, ci hanno permesso di dimostrare la possibilità di produrre la proteina per uso umano con un sistema di cellule procariotiche.

I prossimi passi

In Dompé crediamo che la ricerca sulle neutrofine sia solo agli inizi. Il nostro lavoro sta proseguendo nella direzione della caratterizzazione delle varianti – naturali o biotecnologiche – di queste proteine con l'obiettivo di comprenderne meglio gli effetti su diversi tipi di neuroni.

La nostra ambizione è identificare e produrre nuove e più efficaci proteine adeguate per lo sviluppo farmacologico in diverse indicazioni terapeutiche che offrano alla comunità dei pazienti sempre nuovi strumenti di cura.

In Dompé crediamo che il successo riscontrato nell’oftalmologia sia solo il primo passo nella ricerca di risposte a molte altre condizioni ancora senza una risposta terapeutica adeguata.

Pipeline Neurotrofine

Recombinant Human Nerve Growth Factor (rhNGF)

INN (International Non-proprietary Name): Cenegermin
phase III

Il Nerve Growth Factor (NGF) è un polipeptide essenziale per la sopravvivenza e la crescita dei neuroni nel sistema nervoso simpatico e sensoriale e per la differenziazione dei neuroni nel sistema nervoso centrale. La proteina è altamente conservata attraverso le specie, con NGF umano (hNGF) e NGF murino (mNGF) che condividono il 90% di omologia nella sequenza di aminoacidi della proteina matura.

NGF lega due classi distinte di recettori:

1) recettore della tropomiosina chinasi A (TrkA), una tirosina chinasi transmembrana che è anche conosciuta come recettore NGF ad alta affinità, e

2) recettore NGF a bassa affinità (p75 LNGFR), chiamato anche recettore della neurotrofina p75 (p75NTR).

NGF e i suoi recettori sono presenti, in aggiunta ad altri segmenti sia nel segmento anteriore che in quello posteriore dell'occhio, e giocano un ruolo cruciale nella fisiopatologia di diverse malattie oculari.

On going Clinical studies
NGF0120

Study to Evaluate OXERVATE™ in Patients With Stage 1 Neurotrophic Keratitis (DEFENDO)

Completed Clinical studies
NGF0112

Study to Evaluate Safety, Tolerability and Pharmacokinetics of rhNGF Eye Drops in Healthy Volunteers

NGF0213

Safety and Efficacy of rhNGF Eye Drops at Different Doses in Patients With Dry Eye

NGF0212

Evaluation of Safety and Efficacy of rhNGF in Patients With Stage 2 and 3 Neurotrophic Keratitis. (REPARO)

NGF0113

A Dose Ranging Study to Evaluate the Safety and Potential Efficacy of rhNGF in Patients With Retinitis Pigmentosa (RP) (Lumos)

NGF0214

Evaluation of Efficacy of 20 µg/ml rhNGF New Formulation (With Anti-oxidant) in Patients With Stage 2 and 3 NK

NGF0216

An 8-week Study to Evaluate Safety and Efficacy of NGF Eye Drops Solution Versus Vehicle in Patients With Dry Eye

NEMO

Nerve Growth Factor Eye Drops Treatment in Patients With Retinitis Pigmentosa and Cystoid Macular Edema (NEMO)

NGF0314

Study to Evaluate Safety and Efficacy of rhNGF Eye Drops Solution Versus Vehicle in Patients With Glaucoma (NGF-Glaucoma)

NGF0116

A 8 Weeks Study to Evaluate Efficacy & Safety of rhNGF vs Vehicle in Patients After Cataract and Refractive Surgery

NGF0117

Study to Evaluate Safety, Tolerability & PK of rhNGF in Healthy Volunteers

NGF0118

A Study to Evaluate Safety and Efficacy of rhNGF Eye Solution vs Vehicle in Patients With Moderate to Severe Dry Eye

Pubblicazioni su Neurotrofine

Journal of patient-reported outcomes maggio 2020

Development of the Neurotrophic Keratopathy Questionnaire: Qualitative Research

L.T. Murray

Nature febbraio 2020

Topical recombinant human Nerve growth factor (rh-NGF) is neuroprotective to retinal ganglion cells by targeting secondary degeneration

Guo, L., Davis, B.M., Ravindran, N. et al.

The British journal of ophthalmology gennaio 2020

Effect of Recombinant Human Nerve Growth Factor Eye Drops in Patients With Dry Eye: A Phase IIa, Open Label, Multiple-Dose Study

M Sacchetti et al.

Ophthalmology gennaio 2020

Topical Recombinant Human Nerve Growth Factor (Cenegermin) for Neurotrophic Keratopathy: A Multicenter Randomized Vehicle-Controlled Pivotal Trial

SC Pflugfelder et al.

Investigative Ophthalmology and Visual Science agosto 2019

Effect of topical recombinant human nerve growth factor (cenegermin) on corneal sensitivity in patients with neurotrophic keratitis

Massaro-Giordano M et al.

Value in Health ottobre 2018

Impact of Cenegermin on the quality of life in neurotrophic keratopathy

F. Van Nooten et al.

Ophthalmology settembre 2018

Phase II Randomized, Double-Masked, Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis

S. Bonini et al.

Ophthalmology settembre 2018

Phase I Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis

Bonini et al.

Current eye research luglio 2017

Recombinant Human Nerve Growth Factor Treatment Promotes Photoreceptor Survival in the Retinas of Rats With Retinitis Pigmentosa

M Sacchetti et al.

The ocular surface gennaio 2017

A Two-Week, Randomized, Double-masked Study to Evaluate Safety and Efficacy of Lubricin (150 μg/mL) Eye Drops Versus Sodium Hyaluronate (HA) 0.18% Eye Drops (Vismed®) in Patients With Moderate Dry Eye Disease

A Lambiase et al.

Investigative ophthalmology & visual science settembre 2014

NK1 Receptor Antagonists as a New Treatment for Corneal Neovascularization

F Bignami et al.

Biodrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy giugno 2014

Safety and pharmacokinetics of escalating doses of human recombinant nerve growth factor eye drops in a double-masked, randomized clinical trial

MP Ferrari et al.

Investigative Ophthalmology and Visual Science aprile 2014

Phase I/II dose-ranging, randomized clinical trial of recombinant human nerve growth factor in the treatment of neurotrophic keratitis: Preliminary results

Sinigaglia F. et al.

Investigative Ophthalmology and Visual Science giugno 2013

Phase I, randomized, double-masked, vehicle-controlled study to evaluate safety, tolerability and pharmacokinetics of recombinant human nerve growth factor eye drops in healthy volunteers

Buggage R. et al.

PNAS, Proceedings of the National Academy of Sciences agosto 2009

Experimental and clinical evidence of neuroprotection by nerve growth factor eye drops: Implications for glaucoma

Alessandro Lambiase, Luigi Aloe, Marco Centofanti, Vincenzo Parisi, Flavio Mantelli, Valeria Colafrancesco, Gian Luca Manni, Massimo Gilberto Bucci, Stefano Bonini and Rita Levi Montalcini

The New England Journal of Medicine aprile 1998

Topical Treatment with Nerve Growth Factor for Neurotrophic Keratitis

Stefano Bonini, Alessandro Lambiase, Paolo Rama, Giancarlo Caprioglio, Luigi Aloe

The New England Journal of Medicine aprile 1998

Topical treatment with Nerve Growth Factor for Corneal Neurotrophic Ulcers

Alessandro Lambiase, Paolo Rama, Stefano Bonini, Giancarlo Caprioglio and Luigi Aloe

NGF0112

Study to Evaluate Safety, Tolerability and Pharmacokinetics of rhNGF Eye Drops in Healthy Volunteers

Brief summary

The primary objective of this study is to assess the safety and tolerability of single and multiple ascending doses of rhNGF when administered as eye drops in healthy subjects

detailed description

This is a Phase I, randomised, double-masked, placebo-controlled eye drops administration study of rh-NGF in healthy male and female subjects.

This study consists of a single ascending dose part (part 0 one drop single application). Then single ascending dose part (part A; one drop three times a day) and a multiple ascending dose part (part B; one drop three times a day for five days). All parts of the study will consist of 3 ascending dose levels.

In order to support the dose escalation MAD phase from Covance, Basel to Covance, Leeds, an additional cohort (0M) will be conducted at Covance, Leeds at the same dose level as cohort 1M to ensure a degree of consistency between the two sites, i.e. that no dose escalation stopping criteria were met at either site.

In Part 0, each ascending dose cohort will include 3 subjects treated with one dose of rh-NGF.

In part A, each ascending dose cohort will include 6 subjects treated with rh-NGF and 2 with placebo.

In part B, each ascending dose cohort will include 9 subjects treated with rh-NGF drug and 3 with placebo, in addition to cohort 0M, which will include 3 subjects treated with rh-NGF and 1 with placebo

Click here to know more close

NGF0120

Study to Evaluate OXERVATE™ in Patients With Stage 1 Neurotrophic Keratitis (DEFENDO)

Brief summary

This study is to evaluate the safety and efficacy of OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution in patients with Stage 1 neurotrophic keratitis (NK).

detailed description

An 8-week, Multicenter, Open Label, Prospective Study With 24 Weeks of Follow-up to Evaluate Safety and Efficacy of OXERVATE™ 0.002% (20 mcg/mL) Cenegermin-bkbj Ophthalmic Solution in Patients With Stage 1 Neurotrophic Keratitis (NK)

Click here to know more close

NGF0213

Safety and Efficacy of rhNGF Eye Drops at Different Doses in Patients With Dry Eye

Brief summary

The primary objective of this study was to assess the efficacy and safety of different doses of rhNGF when administered as eye drops to patients with dry eye.

detailed description

This is an open-label study evaluating safety and efficacy of recombinant human nerve growth factor (rhNGF) eye drops at different doses in patients with Dry Eye

Click here to know more close

NGF0212

Evaluation of Safety and Efficacy of rhNGF in Patients With Stage 2 and 3 Neurotrophic Keratitis. (REPARO)

Brief summary

This study is aimed at assessing the safety and the efficacy of two dose regimens of recombinant human nerve growth factor (rhNGF) eye drops solution compared to vehicle for inducing a complete healing of stage 2 (persistent epithelial defect) and 3 (corneal ulcer) neurotrophic keratitis

detailed description

The primary objective of this study is to assess the safety and the efficacy of two dose regimens (10 µg/ml or 20 µg/ml 6 times a day) of recombinant human nerve growth factor (rhNGF) eye drops solution compared to vehicle for inducing a complete healing of stage 2 (persistent epithelial defect) and 3 (corneal ulcer) neurotrophic keratitis (NK) as measured by the Reading Center evaluating the clinical pictures of corneal fluorescein staining.

Secondary objectives of the study are to assess the duration of complete healing, improvement in visual acuity and improvement in corneal sensitivity following treatment with rhNGF eye drops solution

This is a combined phase I/II study. The phase I and II segments of the study will be conducted as an 8 week, randomized, double-masked, vehicle controlled, parallel group study (referred to as the controlled treatment period) followed by a 48 or 56 week follow-up period The design of the phase I and phase II segments of the study are identical with the exception that in the phase I segment of the study the randomization scheme is different and patients will be followed with additional safety assessments and blood samples for PK (pharmacokinetic) profiling In the ascending dose Phase I segment of the study two doses of rhNGF 10 and 20 µg/ml will be evaluated in a sequential manner

Click here to know more close

NGF0113

A Dose Ranging Study to Evaluate the Safety and Potential Efficacy of rhNGF in Patients With Retinitis Pigmentosa (RP) (Lumos)

Brief summary

The primary objective of the study is to assess the safety and tolerability of two dose regimens of recombinant human nerve growth factor (rhNGF) eye drops solution administered over 6 months versus a vehicle control in patients with typical retinitis pigmentosa. The secondary objective of this study is to attempt to show a dose response by assessing the potential efficacy of the rhNGF dose regimens for improving or slowing the deterioration of visual function outcomes at 3 and 6 months. During a 6 month follow-up period patients will be monitored to determine if there is evidence of a persistent biological effect after discontinuation of the study treatment.

detailed description

This is a 24-week phase Ib/II, multicenter, randomized, double-masked, vehicle controlled, parallel-group, dose-ranging study with a 24-week follow-up period to evaluate the safety and potential efficacy of two doses (60 μg/ml and 180 μg/ml) of recombinant human nerve growth factor (rhNGF) eye drops solution versus vehicle in patients with typical retinitis pigmentosa (RP).

Click here to know more close

NGF0214

Evaluation of Efficacy of 20 µg/ml rhNGF New Formulation (With Anti-oxidant) in Patients With Stage 2 and 3 NK

Brief summary

Brief Summary:

The primary objective of this study is to evaluate the efficacy of 20 µg/ml 6 times a day of rhNGF eye drops solution (formulation containing anti-oxidant) compared to vehicle (formulation containing anti-oxidant) given 6 times a day. The evaluation of efficacy is intended as:

detailed description

An 8-week phase II, multicenter, randomized, double-masked, vehicle-controlled, parallel group study with a 24 or 32 week follow-up period to evaluate the efficacy of a formulation containing anti-oxidant of recombinant human nerve growth factor (rhNGF) in 20 μg/ml, eye drops solution versus vehicle containing anti-oxidant in patients with Stage 2 and 3 Neurotrophic Keratitis. The primary objective was to evaluate the efficacy of 20 μg/ml 6 times a day of recombinant human nerve growth factor (rhNGF) containing anti-oxidant, eye drops solution compared to vehicle (formulation containing anti-oxidant) given 6 times a day in inducing a complete healing of stage 2 (PED) and 3 (corneal ulcer) NK as measured by the central reading center, evaluating the clinical pictures of corneal fluorescein staining.

Secondary objectives were to assess the duration of complete healing, improvement in visual acuity and improvement in corneal sensitivity, and percentage of patients achieving complete corneal clearing defined as complete absence of staining on the modified Oxford Scale.

Click here to know more close

NGF0216

An 8-week Study to Evaluate Safety and Efficacy of NGF Eye Drops Solution Versus Vehicle in Patients With Dry Eye

Brief summary

The primary objective of this study was to assess the efficacy and safety of rhNGF when administered as eye drops to patients with dry eye

The secondary objectives of this study were:

detailed description

The proposed phase II study is a single-center, randomized, double-masked, parallel-arm, vehicle-controlled trial, designed to evaluate the safety and efficacy of Recombinant Human Nerve Growth Factor (rhNGF) eye drops at 20 μg/ml concentration administered six times daily for 8 weeks in patients with dry eye. After confirmation of inclusion and exclusion criteria all eligible patients will be randomized at 2:1 ratio to rhNGF or vehicle control treatment with 8 weeks of study treatments administration with 4 weeks Follow-up.

Click here to know more close

NEMO

Nerve Growth Factor Eye Drops Treatment in Patients With Retinitis Pigmentosa and Cystoid Macular Edema (NEMO)

Brief summary

This study aims at investigating the therapeutic potential of recombinant human Nerve Growth Factor ( rhNGF ) eye drops treatment in patients with Retinitis Pigmentosa (RP) associated with cystoid macular edema (CME) in a phase II, randomized, double-masked, controlled clinical trial.

detailed description

This study aims at investigating the therapeutic potential of recombinant human Nerve Growth Factor ( rhNGF ) eye drops treatment in patients with Retinitis Pigmentosa (RP) associated with cystoid macular edema (CME) in a phase II, randomized, double-masked, controlled clinical trial.

Click here to know more close

NGF0314

Study to Evaluate Safety and Efficacy of rhNGF Eye Drops Solution Versus Vehicle in Patients With Glaucoma (NGF-Glaucoma)

Brief summary

The primary objective of the study is to assess the safety and tolerability of a 180μg/ml TID dose regimen of recombinant human nerve growth factor (rhNGF) eye drop solution administered over 8 weeks versus a vehicle control in patients with progressive primary open-angle glaucoma despite IOP control.

The secondary objectives are to measure the changes in BCDVA, visual field, ERG and structural changes in ganglion cell layer and nerve fiber layer thickness measured by optical coherence tomography. The secondary outcomes will be examined at 1, 4 and 8 weeks of therapy, and at 4 and 24 weeks after cessation of therapy (Week 12 visit and Week 32 visit), and will include functional assessments to investigate evidence of a persistent biological effect after discontinuation of the study treatment.

detailed description

This is an 8 Week phase Ib, monocentric, randomized, double-masked, vehicle controlled, parallel groups, study with a 24 Week follow-up period to evaluate the safety and potential efficacy of a 180 μg/ml recombinant human nerve growth factor (rhNGF) eye drops solution versus vehicle in 60 study participants with chronic primary open angle glaucoma.

Participants may qualify with either progressive optic neuropathy despite maximal current therapy (i.e. IOP reduction), or with stabilized IOP but diminished vision (central or peripheral).

Participants with a qualifying eye will be randomized 2:1 to topical recombinant human nerve growth factor (rhNGF) therapy or vehicle placebo control. Examinations for safety and efficacy will occur one week following initiation of therapy, and at 4, 8, 12 and 32 weeks.

All participants in either arm will be followed clinically at 4 weeks after cessation of therapy.

Click here to know more close

NGF0116

A 8 Weeks Study to Evaluate Efficacy & Safety of rhNGF vs Vehicle in Patients After Cataract and Refractive Surgery

Brief summary

The primary objective of this exploratory study is to assess preliminary efficacy and safety of rhNGF when administered as eye drops to patients after cataract and refractive surgery.

The main criteria for evaluation were:

detailed description

The proposed phase II study is a single-centre, randomized, double masked, parallel arm, vehicle-controlled trial, designed to evaluate the preliminary efficacy and safety of rhNGF eye drops at 20 µg/ml concentration administered six times daily for 8 weeks in patients who underwent cataract and corneal refractive surgery, both known to damage the corneal sensory nerve plexus.

After confirmation of inclusion and exclusion criteria all eligible patients will be randomized at 2:1 ratio to rhNGF or vehicle control treatment with 8 weeks of study treatments administration with 4 weeks Follow-up.

Click here to know more close

NGF0117

Study to Evaluate Safety, Tolerability & PK of rhNGF in Healthy Volunteers

Brief summary

The primary objective of this study is to assess the safety and tolerability of a single short-term and a multiple dose scheme of rhNGF when administered as eye drops in healthy subjects of Japanese ethnicity.

The secondary objective of this study is to assess the pharmacokinetics of single and multiple doses of rhNGF when administered as eye drops in healthy subjects of Japanese ethnicity.

detailed description

This is a Phase I, randomized, double-masked, placebo-controlled eye drops administration study of rhNGF in healthy male and female subjects of Japanese Ethnicity to evaluate the Safety, Tolerability and Pharmacokinetics of Recombinant Human Nerve Growth Factor Eye Drops (rhNGF 20 μg/mL -formulation containing L-methionine as excipient) versus vehicle (vehicle control containing L-methionine as excipient) in Healthy Male and Female Volunteers of Japanese Ethnicity. The IMP was administered in the study Eye with the following scheme:

Day 1: One drop instilled into study eye (35 μL, corresponding to 0.70 μg of rhNGF).

Day 2, 3, 4, 5, 6: One drop six times a day (every 2h) into study eye (210 μL, corresponding to 4.20 μg of rhNGF).

Total dose in the study eye will be 31 drops (1085 μL, equivalent to 21.7 μg rhNGF) over 6 days.

The reference product (vehicle) was administered in the study eye with the following scheme:

Day 1: One drop instilled into study eye (35 μL, corresponding to 0 μg of rhNGF].

Day 2, 3, 4, 5, 6: One drop six times a day (every 2h) into study eye (210 μL, corresponding to 0 μg of rhNGF).

A total dose of placebo vehicle in the study eye will be 31 drops (1085 μL, 0 μg rhNGF) over 6 days.

For the Fellow (Non-Study) Eye for all subjects, the scheme was the following:

Day 1: One drop instilled into a fellow eye (35 μL, corresponding to 0 μg of rhNGF).

Day 2, 3, 4, 5, 6: One drop six times a day (every 2h) into a fellow eye (210 μL, corresponding to 0 μg of rhNGF).

A total dose of placebo vehicle in the fellow eye will be 31 drops (1085 μL, 0 μg rhNGF) over 6 days.

Click here to know more close

NGF0118

A Study to Evaluate Safety and Efficacy of rhNGF Eye Solution vs Vehicle in Patients With Moderate to Severe Dry Eye

Brief summary

The primary objective of this study is to assess the efficacy and safety of rhNGF eye drops at 20 μg/ml concentration administered two or three times daily for 4 weeks in patients with moderate to severe dry eye. The trial is designed to perform dose ranging.

detailed description

This is a 4 weeks, Phase II, multicenter, randomized, double-masked, vehicle-controlled, parallel group study with 12 weeks of follow-up to evaluate safety and efficacy of recombinant human Nerve Growth Factor (rhNGF) eye drops solution versus vehicle, in patients with moderate to severe dry eye (DE).

Test product is rhNGF 20 μg/ml; reference product is vehicle. Test and reference will be instilled in both eyes according to the following scheme:

Group 1: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours, e.g. 7:00 am, 02:00 pm; 09:00 pm).

Group 2: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours, e.g. 7:00 am, 02:00 pm; 09:00 pm).

NB: rhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon.

Group 3: vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours, e.g. 7:00 am, 02:00 pm; 09:00 pm).

Randomization 1:1:1 of 300 patients to rhNGF eye drops solution 20 μg/ml TID (100 patients) or rhNGF eye drops solution 20 μg/ml BID + vehicle eye drop SID (100 patients) or vehicle eye drops solution (100 patients) TID for 4 weeks.

Click here to know more close

Dompé farmaceutici S.p.A. Socio Unico / Capitale sociale € 50.000.000,00
REA MI 289519 - Registro Imprese di Milano / Codice Fiscale e Partita IVA (VAT) IT00791570153