Dompe Pharma's Breakthrough Biologic Therapy Oxervate® Achieves First Patient Prescription in China for Neurotrophic Keratitis

Shanghai, February 3, 2021 /PRNewswire/ -- The Zhongshan Ophthalmic Center of Sun Yat-sen University in Guangzhou, China, has achieved the administration of cenegermin ophthalmic solution (Oxervate^®) Prescription for the first patient.

Neurotrophic Keratitis: A Rare, Progressive Ocular Disease^[1], with a complex and insidious etiology, it is prone to missed or misdiagnosis and frequent recurrences. Due to the lack of effective treatments targeting the underlying cause—namely, corneal nerve damage—moderate-to-severe neurotrophic keratitis (NK) is considered one of the most challenging ocular diseases.^[2], it imposes significant impacts and burdens on patients' work, daily life, and psychological well-being.

“The treatment of neurotrophic keratitis is highly complex. Conventional conservative and symptomatic therapies fail to address the root cause and can compromise both the appearance and function of the eye, creating an urgent clinical need for new therapeutic options,” experts stated. Oxervate aids in trigeminal nerve repair, restores tear secretion, promotes corneal tissue healing, and maintains ocular surface homeostasis. The first prescription for a patient marks the formal entry of China’s neurotrophic keratitis field into an era with available pharmacological treatment, bringing new hope to patients with this rare disease.

Oxervate^®Approved for marketing by the China National Medical Products Administration on August 12, 2020, this treatment is indicated for adult patients with moderate to severe neurotrophic keratitis. Administered as a single 8-week course via self-application, it offers a novel therapeutic option that may help patients avoid invasive surgical procedures.

To help patients with neurotrophic keratitis receive effective treatment at an earlier stage, alleviate the financial burden they face during therapy, and improve medication accessibility for patients with rare diseases, a patient assistance program has been established to lower the economic threshold for treatment. This enables patients to try innovative therapeutic options and potentially achieve a cure. Eligible patients may apply by following the “Medxinkang Kangfupay” WeChat official account.

“Oxervate^®“The approval for market launch in China through an expedited review process reflects the Chinese government’s emphasis on urgently needed clinical medications for rare diseases,” said Mr. Cong Fan, General Manager of Dompé Farmaceutici China.，“We are honored to partner with MedxHealth to bring innovative medicines to patients more rapidly. We sincerely hope that this initiative will help more Chinese patients with neurotrophic keratitis benefit from OXERVATE.”^®treatment. We will also work together with all sectors of society to build an innovative therapeutic ecosystem for rare diseases, empowering one another to benefit more patients in China.”

References

[1]. Li Fengming, Xie Lixin. Chinese Ophthalmology [M]. 3rd ed. Beijing: People's Medical Publishing House, 2014:1316-1317.

[2]. Sacchetti M & Lambiase A. Clin Ophthal. 2014;8:571–9; 2