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1 September 2015 Horizon Scanning Research & Intelligence Centre rhngf for neurotrophic keratitis first line LAY SUMMARY This briefing is based on information available at the time of research and a limited literature search. It is not intended to be a definitive statement on the safety, efficacy or effectiveness of the health technology covered and should not be used for commercial purposes or commissioning without additional information. Neurotrophic keratitis is a condition in which the cornea, the front part of the eye, becomes damaged. It is caused by nerve damage which leads to ulcers forming on the cornea that are very difficult to treat. rhngf is a new drug for the treatment of neurotrophic keratitis that is given as eye drops. Some studies have suggested the rhngf may be helpful for people who already have quite severe damage to their eye. If rhngf is licensed for use in the UK, it could be a new treatment option for patients with this condition, which would reduce the need for surgery. NIHR HSRIC ID: This briefing presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the author and not necessarily those of the NHS, the NIHR or the Department of Health. NIHR Horizon Scanning Research & Intelligence Centre, University of Birmingham. nihrhsc@contacts.bham.ac.uk Web:

2 TARGET GROUP Neurotrophic keratitis (NK): due to any underlying aetiology; stage 2 or 3 first line. TECHNOLOGY DESCRIPTION rhngf (Sentinel) is a recombinant human nerve growth factor that targets two receptors, p75ntf and TrkA. Nerve growth factor (NGF) is essential for the survival and growth of sympathetic and sensory neurons, as well as the differentiation of neurons in the central nervous system. The biological effects of NGF are mediated by activation of NGF receptors that are expressed on the anterior segment of the eye (iris, ciliary body, lens, cornea and conjunctiva), intra-ocular tissues, the central visual pathway (lateral geniculate nucleus and visual cortex), as well as the optic nerve and retina. In the phase I/II clinical trial, rhngf is administered as either a 10µg/ml or 20µg/ml eye drop solution, at one drop six times daily. rhngf does not currently have Marketing Authorisation in the EU for any indication. rhngf is also currently in phase II development for the treatment of xerophthalmia. INNOVATION and/or ADVANTAGES If licensed, rhngf will offer an additional treatment option for patients with NK who currently have few effective therapies available. DEVELOPER Dompé. AVAILABILITY, LAUNCH OR MARKETING rhngf is a designated orphan drug in the USA. In phase II clinical trials. PATIENT GROUP BACKGROUND NK is a degenerative disease of the corneal epithelium resulting from impaired corneal innervation 1. This results in a decrease in or absence of corneal sensation and ultimately leads to epithelial keratopathy, ulceration and perforation 2. The most common causes of impairment of corneal sensation are viral infection (herpes simplex and herpes zoster keratoconjunctivitis), intracranial space-occupying lesions (neuroma, meningioma and aneurysms), and/or neurosurgical procedures that damage the trigeminal ophthalmic branch 3,4. Other ocular causes include ocular surface injury (chemical or thermal burns), corneal dystrophy and contact lens wear 3. Many systemic conditions are also associated with the development of corneal anaesthesia, including diabetes mellitus, multiple sclerosis and congenital syndromes 3,4. 2

3 NK is classified into three stages according to severity 1,3 : Stage 1 mild, non-specific signs and symptoms, characterised by corneal epithelial changes with dry and cloudy cornea. Stage 2 non-healing corneal epithelial defect, characterised by recurrent and/or persistent epithelial defects which are surrounded by poorly adherent opaque and oedematous epithelium. Stage 3 often ensues if stage 1 and 2 are not appropriately treated. Characterised by corneal ulcer with stromal involvement which may be complicated by stromal melting and progression to corneal perforation. NHS or GOVERNMENT PRIORITY AREA NHS England. 2013/14 NHS Standard Contract for Specialised Ophthalmology (Adult). D12/S/a. NHS England. 2013/14 NHS Standard Contract for Ophthalmic Pathology Service (All Ages). D12/S(HSS)/b. CLINICAL NEED and BURDEN OF DISEASE NK is classified as an orphan disease with an estimated prevalence of less than 5 per 10,000 individuals worldwide 3. Although the epidemiology of NK is uncertain, the prevalence and incidence of the disease may be estimated from the epidemiological data on conditions associated with NK 3. NK develops in an average 6% of herpetic keratitis cases, which have a prevalence of 149 per 100,000 population, and in 12.8% of herpes zoster keratitis cases, which have a prevalence of 26 per 100,000 population. In addition, 2.8% of patients who underwent surgical procedures for trigeminal neuralgia (1.5 per 10,000 population 5 ) subsequently developed NK 3. The percentage of NK cases associated with other conditions, such as diabetes mellitus, multiple sclerosis, corneal dystrophy, and congenital diseases is not known. In , there were 2,487 hospital admissions for keratitis (ICD-10 H16) equating to 10,639 bed days and 2,642 finished consultant episodes in England 6. The population likely to be eligible to receive rhngf could not be estimated from available published sources. PATIENT PATHWAY RELEVANT GUIDANCE NICE Guidance NICE interventional procedure guidance. Photochemical corneal collagen cross-linkage using riboflavin and ultraviolet A for keratoconus and keratectasia (IPG466). September NICE interventional procedure guidance. Phototherapeutic laser keratectomy for corneal surface irregularities (IPG358). September NICE interventional procedure guidance. Corneal endothelial transplantation (IPG304). June NICE interventional procedure guidance. Corneal implants for keratoconus (IPG227). July

4 NICE interventional procedure guidance. Tissue-cultured limbal stem cell allograft transplant for regrowth of corneal epithelium (IPG216). April NICE interventional procedure guidance. Insertion of hydrogel keratoprosthesis (IPG69). June CURRENT TREATMENT OPTIONS Current treatment of NK aims to prevent progression of corneal damage and to promote epithelial healing 2. Therapy should be promptly initiated, and is based on the clinical stage of the disease 1,2 : Stage 1 o Preservative-free artificial tears. o Punctual occlusion. Stage 2 o Prophylactic antibiotic drops and preservative-free artificial tears. o Corneal or scleral therapeutic contact lenses. o Lateral tarsorrhaphy (surgical closure of the eyelids). o Amniotic membrane transplantation over the epithelial defect. o Injection of botulinum A toxin into the upper eyelid levator muscle. Stage 3 o Prophylactic antibiotic drops and preservative-free artificial tears. o In cases of stromal melting, topical collagenase inhibitors such as N-acetylcysteine, tetracycline or medroxyprogesterone, may be administered. o Lateral tarsorrhaphy. o Conjunctival flap surgery. o Lamellar or penetrating keratoplasty. o Amniotic membrane transplantation. o Larger defects require lamellar or penetrating keratoplasty. EFFICACY and SAFETY Trial Sponsor Status Source of information Location Design Participants Schedule Follow-up Primary outcome/s Secondary outcome/s REPARO, NCT , NGF0212, ; rhngf vs placebo; phase I/II. Dompé farmaceutici SpA. Ongoing. Trial registry 7, manufacturer. EU (incl UK). Randomised, placebo-controlled. n=174; aged 18 years; stage 2 (persistent epithelial defect) or stage 3 (corneal ulcer) neurotrophic keratitis; refractory to one or more conventional non-surgical treatment(s); no prior surgical procedure(s) for the treatment of neurotrophic keratitis; no other ocular disease requiring topic ocular treatment. Randomised to rhngf administered as a 20µg/ml eye drop solution at one drop six times daily; or rhngf 10µg/ml eye drop solution at one drop six times daily; or placebo eye drop solution at one drop six times daily. Active treatment for 8 weeks, follow-up at 48 or 56 weeks. Complete healing of persistent epithelial defect or corneal ulcer. Presence of Anti-NGF antibodies, change in ocular tolerability. 4

5 Expected reporting date Primary completion date reported as Sept ESTIMATED COST and IMPACT COST The cost of rhngf is not yet known. IMPACT - SPECULATIVE Impact on Patients and Carers Reduced mortality/increased length of survival Other. Impact on Health and Social Care Services Increased use of existing services Re-organisation of existing services Other. Reduced symptoms or disability: the company reports rhngf has the potential to be the first potentially curative treatment for patients with stage 2 and 3 NK. No impact identified Decreased use of existing services: the company claim that treatment of NK with rhngf could cause a reduction in need for ophthalmic visits and repetitive surgical procedures for patients with this disease. Need for new services None identified Impact on Costs and Other Resource Use Increased drug treatment costs Other increase in costs. Other: uncertain unit cost compared to existing treatments. Expert opinion suggests that treatment with rhngf could result in reduction in the use of services, particularly the frequency and number of follow-up appointments, which will mitigate against the cost of the new drug (presently unknown) a. Reduced drug treatment costs Other reduction in costs. None identified Other Issues Clinical uncertainty or other research question identified. None identified a Expert personal communication. 5

6 REFERENCES 1 Wells JR and Michelson MA. Diagnosing and treating neurotrophic keratitis. EyeNet Magazine. July-August Bonini S, Rama P, Olzi D et al. Neurotrophic keratitis. Eye 2003;17: Sacchetti M and Lambiase A. Diagnosis and management of neurotrophic keratitis. Clinical Ophthalmology 2014;8: Ophthalmology Management. Neurotrophic Keratopathy: New Treatment Strategies. Accessed 20 August Bhatti MT and Patel R. Neuro-ophthalmic consideration in trigeminal neuralgia and its surgical treatment. Current Opinion in Ophthalmology 2005;16; Health & Social Care Information Centre. Hospital episode statistics for England. Inpatients statistics, ClinicalTrials.gov. Evaluation of efficacy of 20µg/ml rhngf in patients with stage 1 and 2 neurotrophic keratitis. Accessed 20 August

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