- The EyePoint Pharmaceuticals partner has received Chinese approval for an implant to treat a form of eye inflammation.
- Becoming the first company to get a nod in the country based entirely on real-world data.
- The biotechnology qualified the safety profile of the treatment as “favourable”. Ocumension CEO Ye Liu outlined what the resulting approval means for the company.
The partner of EyePoint Pharmaceuticals He received Chinese approval aimed at an ocular implant to treat a form of eye inflammationbecoming the first company to get a nod in the country based entirely on real-world data.
Ocumension Therapeutics paid an initial $1.75 million to access EyePoint’s technology in 2018.
Ocumension solicitous the approval of YUTIO by the National Medical Products Administration (NMPA) in April 2021, claiming two firsts in the process. According to Biotech, the submission was the first for NMPA approval of a sustained release micro-insert with a controlled release rate of up to 36 months and the first time the Chinese regulator has accepted a new drug application based on the real world.
The NMPA’s positive decision triggered another claim, namely that YUTIO it is the first drug approved in China based entirely on real-world data.
Ocumension laid the groundwork for approval by partnering with the Boao Lecheng Super Hospital in September. Together, the hospital and Ocumension they studied YUTIO in the treatment of non-infectious chronic uveitis affecting the posterior segment of the eye.
Ocumension said its research showed that the YUTIO fluocinolone implant can significantly reduce the rate of recurrence and burden of disease in patients with chronic non-infectious uveitis and improve visual acuity.
The biotech qualified the safety profile of the treatment as “favorable”. Ocumension CEO Ye Liu outlined what the resulting approval means for the company.
OT-401 will fill a gap in the treatment of chronic non-infectious uveitis
Noninfectious uveitis is a chronic form of uveitis which can lead to a variety of complications, such as cataracts and glaucoma, and when the inflammation is not controlled immediately, it can also it can lead to vision problems or even permanent vision loss. The complexity of the clinical presentation of non-infectious uveitis and the high degree of similarity between the subtypes pose important diagnostic and differential problems.
Patients with uveitis are most typically characterized by an early age onset and a tendency to relapse, with a mean age of onset of approximately 33 years. Each episode of inflammation causes irreversible damage to the intraocular tissues and 46% of patients eventually develop irreversible reduced vision or blindness, making it the second leading blinding eye disease in China.
As the first product of its kind for the treatment of chronic non-infectious uveitis, YUTIO is the first and only new drug approved by the FDA for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye, with low-dose intraocular administration and stable release of the drug for a period of up to 36 months.
The development and introduction of YUTIO will improve the treatment dilemma of Chinese uveitis patients, delay recurrent attacks, prevent serious systemic complications, and fill a gap in the treatment of non-infectious chronic uveitis.
ABOUT THE COMPANY
Ocumension is a Chinese company of ophthalmic pharmaceutical platforms dedicated to identifying, developing and commercializing world-class or best-in-class ophthalmic therapies.
Till the date, Ocumension has 23 drug actives in the immediate and posterior segments of the eye and has established a complete portfolio of ophthalmic drugs, of which seven products are in phase III clinical trials and its main product, OT-401 (sterile non-bioerodible intravitreal), recently officially approved for marketing.
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