February 2, 2023. Chengdu Shengdi Pharmaceutical Co., Ltd., a subsidiary of Jiangsu Hengrui Pharmaceuticals Co., Ltd. (“Hengrui Pharma”), received the “Notice of Acceptance” from the Chinese National Medical Products Administration (NMPA). The marketing authorization application for SHR8058 (perfluorohexyloctance) eye drops was accepted for the treatment of dry eye disease associated with Meibomian gland dysfunction by NMPA.
SHR8058 is a Class 1 new drug developed by Hengrui Pharma. The marketing authorization application is based on a multi-center, randomized, saline-controlled, double-blind phase III clinical study (study number SHR8058-301). SHR8058 eye drops showed that it can treat dry eye disease associated with Meibomian gland dysfunction, and to significantly improve the symptoms and signs of dry eye disease. Also, SHR8058 eye drops are safe and reliable, well tolerated, and the incidence of local instillation site reaction after taking the drops was comparable to that of placebo.1
About the SHR8058-301 Study
The SHR8058-301 study is a multi-center, randomized, saline-controlled, double-blind phase III clinical study evaluating the efficacy and safety of SHR8058 eye drops for the treatment of dry eye disease associated with Meibomian gland dysfunction. Professor Jieying from Beijing Tongren Hospital affiliated to Capital Medical University (Beijing, China) served as the principal investigator and 17 centers across the People’s Republic of China participated in the study.
The primary study endpoints were: 1) change from baseline of total corneal fluorescein staining (tCFS) at the end of the treatment (day 57) and 2) change from baseline of the eye dryness score of the visual analogue scale (VAS) at the end of the treatment (day 57). Secondary study endpoints included the tCFS at different visits, corneal fluorescein staining in each subregion, the VAS score, the ocular surface disease index (OSDI) questionnaire and their respective changes from baseline as well as safety.
In this study, a total of 312 subjects with dry eye disease associated with Meibomian gland dysfunction were randomized 1:1 to receive either SHR8058 eye drops or placebo (0.6% saline solution) four times a day for 8 weeks. The results of the study showed that SHR8058 eye drops significantly improved symptoms of dry eye and corneal staining scores starting on day 15 of administration, and the efficacy continued until the end of the 57-day trial.
About Dry Eye Disease
Dry eye disease is an eye surface injury caused by a variety of factors. Patients not only suffer from uncomfortable symptoms such as dryness, foreign body sensation, pain or itching, but also visual impairment due to tear film instability, which in turn has a negative impact on their quality of life and even their mental health.
Epidemiological and clinical evidence suggests that 60%-90% of dry eye disease is due to evaporative dry eye disease caused by Meibomian gland dysfunction2, especially as people’s lifestyles, work intensity, and the prevalence of electronic devices increase each year. The clinical treatment of Meibomian gland dysfunction is currently based on physical therapy supplemented by aqueous artificial tears to relieve patients’ ocular discomfort, but the clinical treatment needs are not being met.
About SHR8058 eye drops
SHR8058 is a clear, colorless, particle-free, almost odorless, sterile eye drop with a single active ingredient, perfluorohexyloctane. It does not contain any excipients such as oils, surfactants and preservatives.
SHR8058 eye drops have a very low surface tension and spread rapidly over the surface of the eye. Interacting with the lipophilic portion of the tear film and covering the surface of the aqueous layer of the tear film, SHR8058 eye drops may form a protective layer at the air interface of the tear film and stabilize the tear film, thus preventing excessive tear evaporation. In addition, SHR8058 eye drops may penetrate and interact with the Meibomian glands, dissolve the mucous secretions in the glands leading to a restoration of the Meibomian gland function to secrete lid esters, thus achieving the treatment of lid gland dysfunction related to excessive evaporation type dry eye disease.
Note:
The text above is a translation into English of the original press release by Hengrui Pharma from February 2, 2023. See 3 for the original version.
About Novaliq
Novaliq is a biopharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol®, the worldwide first water-free technology. Novaliq offers an industry-leading portfolio addressing today’s unmet medical needs of millions of patients with eye diseases. In 2019, Hengrui Pharma and Novaliq announced a strategic collaboration under which Hengrui Pharma secured exclusive rights to develop, manufacture, and commercialize NOV03 (local drug name SHR8058 eye drops) and CyclASol® (local drug name SHR8028 Eye Drops) in China. Novaliq GmbH is headquartered in Heidelberg, Germany and Novaliq Inc. has an office in Cambridge, MA, USA. The long-term shareholder is dievini Hopp BioTech holding GmbH & Co. KG, an active investor in Life and Health Sciences companies. More on www.novaliq.com.
References
Bausch + Lomb and Novaliq Announce Publication of Second Pivotal Phase 3 Data on NOV03 (Perfluorohexyloctane) in American Journal of Ophthalmology NOV03 Consistently Met Primary Endpoints for Signs and Symptoms of Dry Eye Disease Associated with Meibomian Gland Dysfunction NOV03 PDUFA Action Date is June 28, 2023
VAUGHAN, Ontario, and HEIDELBERG, Germany, March 22, 2023 – Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), a leading global eye health company dedicated to helping people see better to live better, today announced that American Journal of Ophthalmology has published results from MOJAVE, the second pivotal Phase 3 trial for NOV03 (perfluorohexyloctane). NOV03 is being investigated to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). Results from the first pivotal Phase 3 trial, GOBI, were published earlier this year in Ophthalmology. The U.S. Food and Drug Administration (FDA) assigned NOV03 a Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023.Heidelberg, Germany, and Cambridge, MA, USA, Feb 8, 2023 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced its plans for filing a Marketing Authorisation Application (MAA) for CyclASol® (ciclosporin ophthalmic solution), a first-of-its-kind anti-inflammatory product for the treatment of dry eye disease (DED) in the European Union.