Thu, 07 Jul 2022

BEIJING, June 23, 2022 /PRNewswire/ -- Ocumension Therapeutics 1477.HKannounced that the New Drug Application (NDA) for the core product in its pipeline, OT-401 (Sterile non-bioerodible intravitreal implant, Product  name: YUTIO), was officially approved by the National Pharmaceutical Administration (NMPA) for the treatment of chronic non-infectious uveitis involving the posterior segment of the eye (chronic NIU-PS). This is the first new drug in Ocumension's pipeline to be approved for marketing and is currently the potential best-in-class therapy for the treatment of this indication in China.

Ocumension is a Chinese ophthalmic pharmaceutical platform company dedicated to identifying, developing and commercialising first-in-class or best-in-class ophthalmic therapies. To date, Ocumension has 23 drug assets in the immediate and posterior segments of the eye and has established a complete ophthalmic drug pipeline, of which seven products are in Phase III clinical trials and its core product, OT-401 (Sterile non-bioerodible intravitreal implant), has been officially approved for marketing.

The approval of YUTIO in China marks an important milestone for EyePoint and Ocumension in our shared mission to provide extended-release drug therapy to patients suffering from ocular disease," Nancy, CEO of Eyepoint said. "Since YUTIO was approved in the US three years ago, EyePoint has been offering this innovative ophthalmic treatment for patients with chronic non-infectious uveitis involving the posterior segment of the eye, providing a better standard of care for patients. We are proud to partner with Ocumension to expand YUTIO's global reach as we work together to improve the lives of patients with serious eye diseases and to energise the Chinese market."

OT-401 will fill a gap in the treatment of chronic non-infectious uveitis

Non-infectious uveitis is a chronic form of uveitis that can lead to a variety of complications such as cataracts and glaucoma, and when the inflammation is not promptly controlled, it can also lead to impaired vision or even permanent vision loss. The complexity of the clinical presentation of non-infectious uveitis and the high degree of similarity between subtypes pose significant diagnostic and differential problems.

Patients with uveitis are most typically characterised by an early age onset and have a tendency to relapse, with an average age of onset of approximately 33 years. Each episode of inflammation causes irreversible damage to intraocular tissues and 46% of patients eventually develop irreversible low vision or blindness, making it the second most blinding eye disease in China.

As the first-in-class product for the treatment of chronic non-infectious uveitis, YUTIO is the first and only new FDA-approved drug for the treatment of chronic non-infectious uveitis involving the posterior segment of the eye, with low-dose intraocular administration and stable drug release over 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, avoid serious systemic complications, and fill a gap in the treatment of chronic non-infectious uveitis.

Ophthalmology experts have high hopes for the future contribution of YUTIO in the field of uveitis

The fascinating product OT-401 was first approved by the FDA on 12 October 2018 for the treatment of chronic non-infectious uveitis involving the posterior segment of the eye, and Ocumension subsequently introduced this innovative product to China and became Eyepoint's largest strategic shareholder in 2021. The OT-401 was first used in China in August 2019, providing a powerful treatment for chronic non-infectious uveitis in China, through the "privileged access, early and pilot" policy granted by the State to the Boao LeCheng Advance Hospital, a powerful treatment.

According to public information, Hainan (Boao) International Eye and Vision Eye Hospital was established by Professor Qu Jia's team from the Eye and Vision Hospital of Wenzhou Medical University and Zhejiang Provincial Eye Hospital, which is the first super-specialty platform launched in Boao LeCheng International Medical Tourism Advance Zone, granted to Boao LeCheng Super Eye. With the support of many "high gold" policies, the super ophthalmology department will continue to give full play to the advantages of the ophthalmology specialty of Wen Medical University, and focus on the introduction of licensed drugs and equipment and real-world clinical data research, gradually realising the "three synchronization" of ophthalmology technology, equipment and drugs with an international advanced level, open platform for sharing and win-win cooperation with first-class ophthalmology teams at home and abroad and an "innovation platform for the research and development, transformation and application of cutting-edge international ophthalmology". At present, 28 licensed projects have been introduced and more than 10 real-world research projects are currently underway. Among them, the Johnson Catalys Femtosecond Laser System and Allergan XEN Glaucoma Drainage Tube were selected as the first batch of real-world clinical data research pilots for the device category of the State Drug Administration and were successfully approved, becoming the first batch of licensed devices in China to be registered and marketed using real-world clinical data.

The research for the approved new drug application was conducted by Professor Qu Jia, General Director of Wenzhou Medical University Optometry Hospital and Chief Scientist of the National 973 Program, as the leading PI, Professor Chen Wei, Vice President of Wenzhou Medical University Optometry Hospital and Chief Medical Officer of the Group's Hainan Campus, as the co-PI, and Professor Sun Xin, Director of the Key Laboratory of Real World Data Research and Evaluation of Hainan of the State Drug Administration and Director of the Chinese Evidence-based Medicine Centre of West China Hospital of Sichuan University, as the co-PI. Professor Sun Xin's team was responsible for the overall study design and data statistics. Throughout the course of the study, Liu Mimi, Executive Director of the Hainan Campus of the Wen Medical University Optometry Hospital Group, led the clinical team night and day, working with full dedication. Ltd. took on the CRO role. Ophthalmologists from all over China have high hopes and support for the future contribution of Ursine in the field of uveitis. The professional clinical and CRO team made the whole study more efficient and faster. YUTIO intravitreal implant has been selected as one of the first batch of real-world clinical data study pilots in the pharmaceutical category by the State Drug Administration and has now been officially approved for marketing.

In April 2021, OT-401's NDA filing was accepted by the CDE, accelerating to the market across the board

From the study data, OT-401 has demonstrated satisfactory efficacy and safety. The study data showed that in a real-world treatment setting in China, OT-401 was able to significantly reduce the recurrence rate of uveitis in patients, significantly improve visual acuity, and patients implanted with OT-401 experienced a significant reduction in systemic systemic medication, ocular topical hormone dosage, and significant relief of macular edema. The safety profile was good throughout the follow-up period, with no unintended serious adverse events.

Mr. Liu Ye, Chief Executive Officer of Ocumension, said: "With its low dose intraocular administration and stable drug release over a period of up to 36 months, YUTIO is the first and only new drug approved by the FDA for the treatment of chronic non-infectious uveitis involving the posterior segment of the eye that can release fluphenazole for up to 36 months. This approval is an important event not only for Ocumension , but also for Chinese patients with YUTIO. This dangerous and stubborn disease will now have a long-term effective control method. Everyone will be able to return to a normal life without the fear of losing their sight."

SOURCE Ocumension Therapeutics

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