Dongpei Pharmaceutical's new drug for the treatment of neurotrophic cornealitis, Occiness (R), was approved in China.

Read: The world's only breakthrough biological therapy that promises to cure rare eye diseases.
August 20, 2020 - Italian pharmaceutical company Dongpei Pharmaceuticals announced that China's State Drug Administration has approved its Senejimin drop eye drops (Oshvi®) for the treatment of moderate or severe neurotrophic corneal inflammation (NK), a rare progressional eye disease that causes corneal scar formation and decreased vision.
"neurotrophic cornealitis epidermology complex, prone to repeated attacks and so on, many patients in the consultation has appeared cornea epitural defects or corneal ulcers, need surgery or long-term lid cracks to treat, causing great inconvenience to the patient's working life, " the Chinese Medical Association ophthalmology Professor Shi Weiyun, chairman of the corneal disease group of the branch and director of Shandong Ophthalmology Hospital, said that ®the study shows that by promoting corneal healing and promoting corneal nerve regeneration repair, it is possible to change the way neurotrophic cornealitis is treated and bring new treatments to patients with this rare disease."
" neurotrophic cornealitis is a rare disease caused by impaired nerve function of the cornea due to herpes or other infections, eye damage, eye or neurosurgery, and some systemic diseases such as diabetes that impair corneal perception and nutrition.
if not detected and controlled in a timely manner, the disease will gradually worsen and lead to persistent epidural defects, corneal ulcers, substation dissolution, perforation and vision loss.
, the treatment choice of neurotrophic cornealitis has been limited to the treatment of the disease, not from the cause of the disease and corneal nerve damage.
The current treatments include artificial tears, self-contained serum drops of eye fluid, blephary stitching (an operation to stitch parts of the eyelids together) and upper lid drooping (eyelid closure) caused by Botox.
other surgical procedures designed to restore corneal integrity, including conjunctivation valve surgery and corneal transplants, are invasive and can impair the appearance and function of the eyes.
Senegimin is a new type of recombinant human neurogrowth factor (rhNGF), which is structurally identical to the neurogrowth factor (NGF) protein produced in the body and contained in eye tissue, and is based on which Osivi ® has been successfully developed.
endogenous protein strongly supports cornea integrity through a variety of mechanisms and acts directly on corneal cells to stimulate cell growth and survival.
addition, NGF is known to promote tear secretion in combination with receptors on the tear glands, providing lubrication and natural protection to the eyes from pathogens and injuries.
protein has been shown to support corneal nerve domination, a neurological function that has been lost in neurotrophic cornealitis.
scientists discovered the regenerative potential of NGF and won the Nobel Prize for it, but its therapeutic potential has not been transformed and applied in the field of ophthalmology.
finally, Dongpei Pharmaceuticals' research and development center in L'Aquila, Italy, produced recombinant NGF (Senejimin) through an original research and development process.
series of subsequent trials conducted by the company confirmed the safety and effectiveness of Senejimin in the treatment of neurotrophic corneatitis.
Osivi ® represents the first local drug products in the field of eye science, and is also the first application of human neurogenesis as a drug or therapeutic means.
"Essevi® is our first approved product in China.
," said Mr. Sergio Domp?, chairman of Dongpei Pharmaceuticals.
"We are pleased to offer such an important treatment to patients with neurotrophic cornealitis in China, and are very grateful to the vast number of patients and doctors who have been actively involved in clinical trials and contributed to our progress today.
as Italy's leading biopharmaceutical company with research and development at its core, we are committed to exploring more innovative and valuable treatment options and models to meet the needs of complex diseases that lack treatment options.
, we will actively and continuously introduce more innovative therapies and research and development projects to China for the benefit of more Chinese patients.
"Oswei® has been approved for adults with moderate or severe neurotrophic cornealitis, a course of 8 weeks, during which patients can easily complete self-dosing, as a single treatment for patients to avoid invasive surgery a new treatment option. the effectiveness and safety of
Seneguimin eye drops (Osivi®) safety and effectiveness data Osivi® have been confirmed in two independent double-blind randomized multi-center controlled clinical trials.
project had the largest population of neurotrophic cornealitis patients in randomized controlled trials.
both trials studied the efficacy and safety of Oswei ® as a monotherapy (20 ?g/mL) in patients with moderate or severe neurotrophic cornealitis, and compared it with the treatment of artificial tear-like agents without preservatives.
study in Europe, NGF0212 (REPARO, which means "repair"), randomly assigned 52 patients to subgroups, and after eight weeks of treatment, about 72 percent of the patients in the treatment group were completely cured.
study conducted in the United States, NGF0214 randomly assigned 24 patients to subgroups, of which 65.2% were fully cured.
follow-up for the REPARO study, which found that about 82 percent of patients who received a cure after an eight-week course remained stable after one year.
is ideal ® tolerance of Osweiler in clinical trials.
eye pain is the most common adverse reaction to Osivi®, with about 16 percent of patients reporting eye pain, which may be associated with loss of knowledge due to illness to recover.
reported adverse events in more than 5% of patients included swelling of the eyes (inflammation), increased tear (increased tear secretion), and eye congestion.
study of the REPARO pilot project was published in the September 2018 issue of the Journal of the American Academy of Ophthalmology.
study of the U.S. pilot project was published in the January 2020 issue of Opthalmology.
about neurotrophic cornealitis is the densest tissue in the human nerve, with about 7,000 nerve endings per square millimeter.
these nerves provide unique and irreplaceable support for the cornea, which often has no blood vessels and is essential to maintain corneal transparency.
fact, corneal nerves help maintain eye health by producing soluble factors called neural media and promoting auditory-dependent winks and tear reflections.
neurotrophic corneal disease, also known as neurotrophic corneal lesions, is a rare eye disease caused by any level of damage to the fifth cranial nerve (trigeyrigen nerve).
causes of damaged corneal perception include herpes infections or other infections, eye or neurosurgery, physical damage to the eye surface, and some systemic diseases that impair perception.
neurotrophic cornealitis can develop into corneal scarring and vision loss.
diagnosis, prognosis and treatment are based on the severity of the disease and can be roughly divided into three stages.
Phase 1 (mildly) is manifested in irregular eye surfaces and decreased vision, Phase 2 (moderate) is manifested as non-healing persistent epitome (PED), phase 3 (severe) is manifested as corneal ulcers, involving subsurfic (substitular) tissue, and may progress into corneal dissolution and perforation.
patients with advanced neurotrophic cornealitis are usually treated by corneal specialists.
.