Agreement,
DED,
Partnership,
ASEAN,
Refraction,
Drug discovery,
New Drug Application,
Vibration,
NDA,
Good,
Wafer,
Research,
ASCRS,
MS,
Trial of the century,
U.S. FDA,
Telecanthus,
Incidence,
Ophthalmology,
American Society of Cataract and Refractive Surgery,
Benjamin,
Eyelid,
Meibomian gland dysfunction,
Patient,
SEHK,
ELM,
Gland,
Cataract,
FDA,
Society,
Pharmaceutical industry,
Tmall,
MD,
Greater China By uniquely combining several mechanisms, ELM delivers heat to the eyelids to lower the viscosity of the oil (i.e.
Key Points:
- By uniquely combining several mechanisms, ELM delivers heat to the eyelids to lower the viscosity of the oil (i.e.
- We always strive to deliver the best treatment options with a combination of drugs and medical devices to patients.
- With the ELM, we have reimagined dry eye treatment, and have created a solution that is remarkably effective, affordable, and convenient.
- Eyedetec Medical, Inc., is a medical device company with a mission to research and develop a portfolio of novel technologies to address the growing problem of dry eye disease.
Analysis of this multi-center, international study, performed after three years of treatment and follow up, demonstrates strong safety and efficacy for NVK002 as a potential treatment for the progression of myopia in children.
Key Points:
- Analysis of this multi-center, international study, performed after three years of treatment and follow up, demonstrates strong safety and efficacy for NVK002 as a potential treatment for the progression of myopia in children.
- CHAMP is a three-arm, randomized, double-masked, placebo-controlled Phase III clinical study conducted across the U.S. and Europe in nearly 600 children and adolescents aged three to seventeen years at enrollment.
- "The CHAMP study shows us that Vyluma's novel formulation of low-dose atropine can make a clinically meaningful difference in treating children with myopia.
- If approved by the FDA, NVK002 would be a first-in-class, clinically proven pharmaceutical agent for the treatment of myopia progression in children.
Retrieved on:
Monday, September 19, 2022
Retrieved on:
Wednesday, August 24, 2022
Retrieved on:
Wednesday, August 3, 2022
World,
Motherboard,
Atropine,
Ageing,
State Council,
Parent,
Eye,
Safety,
Episode I,
Sun,
Ministry,
Director,
Company,
Fudan University,
S. D. Warren Co. v. Maine Board of Environmental Protection,
Eye and ENT Hospital of Fudan University,
Control,
Research,
World Health Organization,
Technology,
US Foods,
Growth,
List of education ministries,
Education,
Business,
Adolescence,
Food,
SEHK,
CEO,
Board,
Ophthalmology,
Achievement,
FDA,
Benjamin,
National Health Planning and Resources Development Act,
Cover My Eyes (Pain and Heaven),
Approximation error,
Beijing Tongren Hospital,
NDA,
CIC,
The Company,
Hospital,
Principal,
Hong Kong Stock Exchange,
Patient,
Overalls,
Pharmaceutical industry,
Vaccine,
Medical imaging,
Myopia The primary objective of the China CHAMP and Mini-CHAMP trials is to evaluate the efficacy and safety of NVK002 for the treatment of myopia progression in children and adolescents.
Key Points:
- The primary objective of the China CHAMP and Mini-CHAMP trials is to evaluate the efficacy and safety of NVK002 for the treatment of myopia progression in children and adolescents.
- These early completions of patient recruitment across both trials, gives the company a strong headstart in moving towards its goal to lead the market in launching a myopia progression treatment drug.
- Following this, a New Drug Application ("NDA") submission to the US Food and Drug Administration (the "FDA") is expected in 2023.
- Dr. Li Xiaoyi (Benjamin), Chairman of the Board of Directors, Executive Director and CEO of Zhaoke Ophthalmology, said, "The early completion of the patient recruitment of NVK002's Phase III clinical trials marks another huge and exciting milestone for Zhaoke Ophthalmology.
Retrieved on:
Monday, November 15, 2021
General Health,
Health,
Science,
Research,
Optical,
Macular degeneration,
Senescence,
Ophthalmology,
Ophthalmic,
Vision,
PAN-90806,
PanOptica,
Zhaoke Ophthalmology Limited,
PAN-90806,
PANOPTICA,
ZHAOKE OPHTHALMOLOGY LIMITED PanOptica, Inc. today confirms the licensing agreement with Zhaoke Ophthalmology Limited (HKEX Stock Code: 6622.HK) to develop and commercialize PAN-90806, an investigational topical eye drop for the treatment of neovascular eye diseases, including wet age-related macular degeneration (wet AMD) and diabetic retinopathy, in China, South Korea, and southeast Asia.
Key Points:
- PanOptica, Inc. today confirms the licensing agreement with Zhaoke Ophthalmology Limited (HKEX Stock Code: 6622.HK) to develop and commercialize PAN-90806, an investigational topical eye drop for the treatment of neovascular eye diseases, including wet age-related macular degeneration (wet AMD) and diabetic retinopathy, in China, South Korea, and southeast Asia.
- PanOptica will support Zhaoke Ophthalmology through the provision of its expertise and know-how, as well as its existing supply of investigational product and/or active pharmaceutical ingredient.
- Zhaoke Ophthalmology Limited is an ophthalmic pharmaceutical company dedicated to the research, development, and commercialization of therapies that address significant unmet medical needs.
- Zhaoke Ophthalmology has received strong endorsement from blue-chip pre-IPO investors, including GIC, Hillhouse Capital, TPG, Loyal Valley Capital, OrbiMed, and Aier Eye Hospital.
Pharmaceutical industry,
Good practice,
Pharmaceuticals policy,
Articles,
Life sciences,
Quality,
Health sciences,
Food safety,
Good manufacturing practice,
Inspection,
Good automated manufacturing practice,
Validation The inspection verified the original records and information on the research and development as well as the manufacturing processes of the above two drug products.
Key Points:
- The inspection verified the original records and information on the research and development as well as the manufacturing processes of the above two drug products.
- The Company also passed the Good Manufacturing Practice (GMP) compliance inspection conducted by the Guangdong Medical Products Administration.
- Passing the on-site inspection for drug registration and GMP compliance is a major milestone for the Company.
- It also validates that such systems can produce products compliant with the registration requirements in a sustained and consistent fashion.
