<0.001 EU per 1 μg of the peptide by the LAL method
Lyophilized protein should be stored at < -20°C, though stable at room temperature for 3 weeks. Reconstituted protein solution can be stored at 2-8 °C for 1 week. Aliquots of reconstituted samples are stable at < -20°C for 3 months.
Cenegermin is indicated for the treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults.
Examples of Clinical Use:
Little to no pharmacodynamic studies have yet been conducted in humans.
Mechanism of action:
Nerve growth factor is subsequently an endogenous protein involved in the differentiation and maintenance of neurons, which acts through specific high-affinity (i.e., TrkA) and low-affinity (i.e. p75NTR) nerve growth factor receptors. Nerve growth factor receptors are expressed in the anterior segment of the eye (cornea, conjunctiva, iris, ciliary body, and lens), by the lacrimal gland, and by posterior segment intraocular tissues. The treatment with cenegermin, administered as eye drops, is intended to allow restoration of corneal integrity.
Cenegermin is a recombinant human nerve growth factor (β polypeptide) drug, also known as rhNGF. It is a protein made by genetic engineering technology and has the biological activity of nerve growth factor. Nerve growth factor (NGF) is a protein that plays an important role in the nervous system. It can promote the growth, differentiation, and survival of nerve cells, and also participate in the maintenance and repair of the function of the nervous system. Cenegermin is usually used in the form of eye drops, which are instillation into the eye multiple times a day. In summary, Cenegermin is a recombinant human nerve growth factor drug used to treat diseases caused by corneal defects, which improves corneal function and eye health by promoting the growth and repair of nerve cells.
Clinical Application of Cenegermin
Cenegermin is mainly used to treat diseases caused by corneal defects, such as neuropathic keratitis and dry eye. Some of the clinical uses of Cenegermin are as follows: (1) Treatment of neuropathic keratitis: Cenegermin can promote the regeneration and repair of corneal nerve cells, thereby improving the symptoms of neuropathic keratitis, such as eye pain, blurred vision, and light sensitivity. (2) Dry eye treatment: Cenegermin can promote the secretion of tears and the repair of the eye surface, and improve the symptoms of dry eye, such as dry eye, eye itching, fatigue, and blurred vision. (3) Cenegermin can promote corneal nerve regeneration and repair, and accelerate the recovery process of corneal transplantation.
Mechanism of Cenegermin
The mechanism of action of Cenegermin is mainly related to the activity of nerve growth factor (NGF). Cenegermin, as a recombinant human β-nerve growth factor polypeptide, can bind to the corresponding NGF receptor, thereby activating the proliferation and differentiation of nerve cells. In ocular neurological diseases, Cenegermin can stimulate the regeneration of damaged corneal nerve cells, promote repair, and restore visual function, which is of great significance for the treatment of neurodegenerative diseases, such as neurotrophic keratitis. It can stimulate the proliferation and differentiation of corneal epithelial cells and promote the regeneration of normal ocular surface structures. In addition, Cenegermin can also improve the ocular surface environment, and increase ocular lubrication and anti-infection ability, thereby improving the overall health status of the cornea. In conclusion, Cenegermin promotes the proliferation and differentiation of nerve cells, increases neuronal survival, and promotes the repair and regeneration of ocular tissues by binding to NGF receptor.
Advantages and Disadvantages
Cenegermin, as a recombinant human nerve growth factor drug, has the following advantages and disadvantages in clinical application: Advantages: (1) Promote regeneration and repair of nerve cells: Cenegermin can bind to receptors on the surface of nerve cells, promote the growth and repair of nerve cells, and help to improve the symptoms of diseases such as neurokeratitis and dry eye. (2) High efficacy: clinical trials have shown that Cenegermin can significantly improve the density and function of corneal nerve, and improve the visual quality and eye health of patients. (3) Safety: Cenegermin is a genetically engineered protein drug, similar to its nerve growth factor, with a low risk of toxicity and side effects. Disadvantages: (1) Need for long-term use: Cenegermin usually requires long-term use, with multiple daily instillation into the eye. This can be inconvenient for the patient and requires adherence to the doctor's treatment protocol. (2) High cost: Since Cenegermin is a genetically engineered drug, its production cost is high, leading to its high price. This may have limited use in some patients. (3) Cenegermin may not be suitable for some patients: Cenegermin may not be suitable for all patients, such as those who are allergic to the drug or have other contraindications. Therefore, consultation with a physician and a thorough evaluation are required before use.
Pipelines of Cenegermin
Cenegermin (Oxervate) has been approved by the FDA as a treatment for neuroatrophic keratitis. It was approved by the FDA in August 2018 and approved by the European Medicines Agency (EMA) as a treatment for corneal epithelial defects and nerve atrophy. At present, the research work on Cenegermin is ongoing, and the relevant pharmaceutical companies and research institutions are carrying out a variety of different clinical trials to explore the therapeutic effect of Cenegermin on other diseases and explore its broader application prospects. At present, Cenegermin is still being used in many clinical trials, including the treatment of poor wound healing, retinopathy of prematurity, high myopia, dry eye syndrome caused by drugs and burns, subarachnoid hemorrhage, etc. Through these studies, we can understand the potential of Cenegermin in other fields.
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