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Astellas Pharma’s Izervay sNDA for Geographic Atrophy Receives FDA Complete Response Letter
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Japan-based Astellas Pharma Inc. (TYO: 4568) has announced that its supplemental New Drug Application (sNDA) for Izervay (avacincaptad pegol), indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), has received a Complete Response Letter (CRL) from the US FDA. The CRL addresses a statistical matter…
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Zhejiang Dian Diagnostics Partners with SNN/CRHA for Optic Nerve Disease Research
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China-based Zhejiang Dian Diagnostics Co., Ltd (SHE: 300244), a leading diagnostic solutions provider, has formed a strategic partnership with the Society for Neuroscience and Neurology, Chinese Research Hospital Association (SNN/CRHA). This collaboration is aimed at conducting comprehensive research into the genetic underpinnings of optic nerve-related diseases, marking a significant step…
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Arctic Vision and Santen Ink Deal for ARVN001 Commercialization in China
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China-based ophthalmology specialist, Arctic Vision, has entered into a strategic collaboration with Japan’s Santen Pharmaceutical (TYO: 4536) for the commercialization of ARVN001, an innovative triamcinolone acetonide suprachoroidal injectable suspension. This partnership marks a significant step in the expansion of ophthalmic treatments, with Santen securing exclusive commercialization rights in mainland China…
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Boehringer Ingelheim Joins MTM Vision Consortium to Advance Diabetes Retinopathy Research
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Germany-based pharmaceutical major Boehringer Ingelheim has announced the initiation of a long-term collaboration with the Mary Tyler Moore Vision Initiative (MTM Vision), marking the first time a pharmaceutical company has joined the MTM Vision Consortium. This partnership signifies a significant step in collaborative research aimed at addressing vision-related complications of…
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Frontera Therapeutics Receives FDA Approval for Phase II Study of FT-003 in nAMD
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Frontera Therapeutics, Inc., a Sino-US biopharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase II clinical study for its investigational drug FT-003. This recombinant adeno-associated virus (rAAV) gene therapy is designed for the treatment of neovascular age-related macular…
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HuidaGene Receives FDA Clinical Clearance for HG202 in Neovascular AMD Treatment
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China-based HuidaGene (Shanghai) Biotechnology Co., Ltd has announced receiving clinical clearance from the US Food and Drug Administration (FDA) for its drug candidate HG202, an innovative treatment for neovascular age-related macular degeneration (nAMD). BRIGHT Study to Assess Safety and Tolerability of HG202The upcoming BRIGHT study, an open-label, multicenter dosage escalation…
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China Grand Pharmaceutical Completes Phase III Clinical Study for Post-Cataract Surgery Treatment
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced the successful completion of a Phase III clinical study for its investigational drug, GPN00833, used for inflammation and pain management following cataract surgery in China, meeting all clinical endpoints. GPN00833: A Nanosuspension Eye Drop for Inflammation and PainGPN00833…
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Lee’s Pharmaceutical’s Subsidiary Reports Positive Results from Phase III Myopia Treatment Study
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), a China-based pharmaceutical company, through its subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622), has announced positive top-line results from the Phase III China CHAMP study for NVK002, an atropine external use eye solution designed to address myopia progression. The Phase III study, a randomized, double-blinded,…
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Grifols Partners with BARDA to Develop Treatment for Sulfur Mustard Ocular Injury
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Grifols (BME: GRF; NASDAQ: GRFS), a Spanish biopharmaceutical company, has announced a partnership with the Biomedical Advanced Research and Development Authority (BARDA) to test investigational ocular surface immunoglobulin (OSIG) eye drops for their potential to treat ocular damage resulting from sulfur mustard exposure. BARDA, which is part of the Administration…
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LENZ Therapeutics’ Presbyopia Therapy LNZ100 Accepted for FDA Review
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LENZ Therapeutics, Inc. (NASDAQ: LENZ), a US-based biopharmaceutical company, has announced that the US Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for LNZ100 (aceclidine), a therapy for presbyopia. The FDA has set an action date of August 8, 2025, for the application. LNZ100…
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Innovec Pharma’s IVB103 Gene Therapy for nAMD Receives Clinical Trial Approval from China’s CDE
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Beijing Innovec Pharmaceutical Technology Co., Ltd., a leading gene therapy company based in China, has announced that it has received clinical trial approval from the Center for Drug Evaluation (CDE) for its IVB103 treatment for neovascular (wet) age-related macular degeneration (nAMD). This follows a clinical trial approval for the same…
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United Laboratories’ TUL12101 Eye Drops Enter Phase IIa Clinical Trial for Dry Eye Syndrome
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United Laboratories International Holdings Ltd (HKG: 3933), a Hong Kong-based pharmaceutical company, has announced the enrollment of the first subject in the Phase IIa clinical study for its Category 1 drug, TUL12101 eye drops, in China. This development marks a significant step forward in the clinical evaluation of the drug.…
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Roche’s Vabysmo Receives NMPA Approval for Macular Edema Treatments in China
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Roche (SWX: ROG), the Swiss pharmaceutical giant, has announced the receipt of another marketing approval from the National Medical Products Administration (NMPA) for its ophthalmology bispecific antibody (BsAb) Vabysmo (faricimab). The new indication is for macular edema secondary to central retinal vein occlusion (CRVO) or hemi-retinal vein occlusion (HRVO). Vabysmo,…
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iRegene Therapeutics Secures Over USD 14 Million in Series B Financing to Advance Cell Therapies
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iRegene Therapeutics, a Wuhan-based biotechnology company specializing in the development of AI-enhanced chemically induced cell therapies, has announced the successful completion of its Series B financing round, raising over RMB 100 million (USD 14.15 million). The financing was co-led by Orinno Capital, with additional investments from Optics Valley Industrial Investment…
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Reforgene Medicine’s Gene Editing Therapy RM-101 Clears IND Hurdle for Usher Syndrome Treatment
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Reforgene Medicine, a pioneer in gene editing therapy based in Guangzhou, has secured Investigational New Drug (IND) approval from China’s National Medical Products Administration (NMPA) for its flagship candidate, RM-101. This AAV-based gene editing drug is aimed at treating Usher syndrome, a genetic condition that leads to significant vision impairment…
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Novartis’s Brolucizumab Accepted for Review by China’s CDE for Potential DME Treatment
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The Center for Drug Evaluation (CDE) has indicated that Novartis (NYSE: NVS), the Swiss pharmaceutical giant, has had its second market filing for brolucizumab accepted for review. The filing is anticipated to be for the treatment of visual impairment resulting from macular edema associated with diabetes (DME). Brolucizumab, recognized as…
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HOYA Surgical Optics Expands in China with New Artificial Intraocular Lens Facility
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HOYA Surgical Optics has established its presence in the Suzhou High-Tech Zone of Jiangsu province, China, with a focus on developing artificial intraocular lenses and their implantation systems to benefit a broader patient base affected by cataracts. HOYA Surgical Optics, a subsidiary of Japan’s Hoya Corporation, holds a leading position…
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Amgen’s Tepezza Receives Approval in Japan for Treating Thyroid Eye Disease
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Amgen (NASDAQ: AMGN), a prominent biotechnology company based in the U.S., has announced that its drug Tepezza (teprotumumab, genetical recombination) has received market approval in Japan. The country’s Ministry of Health, Labour, and Welfare (MHLW) has authorized the medication for treating active or high clinical activity score (CAS) thyroid eye…
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Frontera Therapeutics Receives FDA Approval for Phase II Study of First Chinese rAAV Gene Therapy
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Frontera Therapeutics, Inc., a Sino-US biopharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase II clinical study for its investigational gene therapy, FT-002. This recombinant adeno-associated virus (rAAV) gene therapy candidate marks a significant milestone as the…
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Ocumension Therapeutics’ OT-502 Receives NMPA Acceptance for Post-Cataract Inflammation Treatment
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Ocumension Therapeutics (HKG: 1477) announced on September 23, 2024, that the National Medical Products Administration (NMPA) in China has accepted its New Drug Application (NDA) for OT-502 (DEXYCU, dexamethasone implant). This ophthalmic new drug is designed to treat postoperative inflammation and is indicated for suppressing inflammation and related complications in…
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Lee’s Pharmaceutical’s Zhaoke Ophthalmology Receives NMPA Approval for Generic Lumigan
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), through its subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622), has announced that it has received market approval from China’s National Medical Products Administration (NMPA) for its generic version of Allergan’s (NYSE: AGN) Lumigan (bimatoprost), a treatment for glaucoma. The product, marketed under the Chinese trade…
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Ocumension Therapeutics’ Zerviate Receives Marketing Approval in China for Allergic Conjunctivitis Treatment
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Ocumension Therapeutics (HKG: 1477), a leading ophthalmology specialist in China, has announced that its histamine H1 receptor-targeted drug Zerviate (OT-1001) has been granted marketing approval in China with priority review status. The drug is indicated for the treatment of itching symptoms associated with allergic conjunctivitis. Zerviate, originally developed by the…
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Hangzhou-Based Ophthalmic Device Maker MDCO Secures RMB 200 Million in Series B Funding
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MDCO, an ophthalmic medical device company headquartered in Hangzhou, has reportedly secured nearly RMB 200 million in a Series B financing round. The funding was led by Hangzhou Qiantang Heda Bio-medical Investment Fund, Sunland Capital, and existing investor Decheng Capital. The capital raised will be allocated to bolster the company’s…
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Skyline Therapeutics’ Gene Therapy Receives FDA Orphan Drug Designation for Retinitis Pigmentosa Treatment
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Skyline Therapeutics, a biopharmaceutical company based in China, has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its proprietary adeno-associated virus (AAV) gene therapy, SKG1108, for the treatment of retinitis pigmentosa (RP). This innovative therapy utilizes a novel AAV vector, including a groundbreaking capsid…
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Sinocelltech’s Anti-Angiogenic Biologic SCT520FF Gets NMPA Green Light for Neovascular AMD Clinical Study
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SHANGHAI—Sinocelltech Group Ltd (SHA: 688520), a Chinese biopharmaceutical company, has announced that it has received clearance from the National Medical Products Administration (NMPA) to proceed with a clinical study for its in-house developed anti-angiogenic biologic drug, SCT520FF, for the treatment of neovascular age-related macular degeneration (nAMD). The drug SCT520FF is…
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Ocumension Therapeutics to Repurchase Shares, Demonstrating Confidence and Commitment to Investor Rights
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Ocumension Therapeutics, a biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 1477), has declared its intent to proceed with a share repurchase program, targeting 10% of the total issued shares, excluding treasury shares. This initiative, which is not to exceed HKD 200 million, is…
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Qilu Pharmaceutical’s Biosimilar Ranibizumab Receives NMPA Approval, Marking a First in China
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Qilu Pharmaceutical, a Chinese pharmaceutical company, has announced that its biosimilar version of Novartis’s blockbuster drug Lucentis (ranibizumab) has received market approval from the National Medical Products Administration (NMPA). This regulatory nod positions the product as the first biosimilar of its kind to be approved in China. Ranibizumab, a vascular…
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Robotrak Secures NMPA License for China’s First Smart Ophthalmic Navigation Laser
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Robotrak, a Nanjing-based ophthalmic innovation platform, has secured a Category III medical device license from the National Medical Products Administration (NMPA) for its cutting-edge smart ophthalmic navigation laser. This marks the first such device of its kind in China. The all-solid-state laser photocoagulation device offers a suite of advanced features,…
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New Agreement Enhances Myopia Solutions: Hong Kong Polytechnic and Zeiss Collaborate
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The School of Optometry at Hong Kong Polytechnic University has announced a new cooperation agreement with global optical leader Zeiss, further strengthening their existing partnership. This collaboration will leverage the patented “Defocus Integrated Soft Contact (DISC) Technology for Myopia Management,” developed by Hong Kong Polytechnic University, to enhance Zeiss’ MyoCare…
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Ocumension Therapeutics Partners with Alcon Laboratories, Secures Rights to Ophthalmic Products in China
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Ocumension Therapeutics (HKG: 1477), a biopharmaceutical company based in China, has entered into a strategic partnership with Alcon Laboratories Inc., a global leader in eye care and a subsidiary of Novartis. Under the terms of the agreement, Alcon will provide Ocumension with research and development, manufacturing, and commercialization rights for…
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Lee’s Pharma Subsidiary Receives Green Light for Phase III Dry Eye Study and Completes Myopia Trial
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), a prominent Chinese pharmaceutical company, through its subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622), has announced significant advancements in its ophthalmic pipeline. The company’s cyclosporine A gel, intended for the treatment of dry eye, has received clearance to proceed to a Phase III clinical study…
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Cloudbreak Pharma Partners with Santen Pharmaceutical for CBT-001 Commercialization in Southeast Asia
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Cloudbreak Pharma Inc., a U.S.-based biopharmaceutical company, has entered into a strategic partnership with Japanese pharmaceutical firm Santen Pharmaceutical. The collaboration focuses on the development, manufacturing, and commercialization of Cloudbreak’s investigational drug, CBT-001, across Southeast Asia, including key markets such as Japan, Korea, Vietnam, Thailand, Malaysia, the Philippines, Singapore, and…
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Sinqi Pharmaceutical Gets NMPA Green Light for SQ-22031 Eye Drops to Treat Dry Eye Syndrome and Neurotrophic Keratitis
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Shenyang Sinqi Pharmaceutical Co., Ltd (SHE: 300573), a pharmaceutical company based in China, has received clinical trial approval from the National Medical Products Administration (NMPA) for its therapeutic biologic, SQ-22031 eye drops. This Category 1 therapeutic biologic is intended for the treatment of dry eye syndrome and neurotrophic keratitis, with…
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Roche’s H1’24 Financials Show 5% Growth, Eye Care and Cancer Therapies Drive Sales
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Roche (SWX: ROG, OTCMKTS: RHHBY, SWX: RO), the Swiss pharmaceutical and diagnostics giant, has reported its financial results for the first half of 2024, with group sales remaining stable in Swiss franc terms. However, on a constant exchange rate basis, sales increased by 5% year-on-year to CHF 29.85 billion (USD…
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TowardPi Medical Partners with OCULUS Iberia to Introduce Advanced OCTA Technology to Spain
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TowardPi (Beijing) Medical Technology Ltd, a Chinese medical technology company specializing in ophthalmic imaging, has secured a partnership with OCULUS Iberia, headquartered in Madrid. This strategic alliance will see TowardPi’s cutting-edge optical coherence tomography angiography (OCTA) technology, with a speed range of 100,000 to 400,000 scans per second, introduced to…
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Ocumension Therapeutics and Shandong Boan Biotechnology File for Market Approval of Biosimilar Aflibercept in China
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Ocumension Therapeutics (HKG: 1477) and Shandong Boan Biotechnology Co., Ltd (HKG: 6955) have jointly announced the submission of a market approval filing to the National Medical Products Administration (NMPA) for their co-developed biosimilar version of Bayer’s Eylea (aflibercept). This biosimilar has the potential to be the latest entry in the…
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Staidson Pharmaceutical Gets NMPA Green Light for Neurotrophic Keratitis Eye Drop Clinical Trial
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Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a biopharmaceutical company based in China, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its investigational STSP-0902 eye drops, which are intended for the treatment of neurotrophic keratitis (NK). Neurotrophic keratitis, also referred to as…
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Semaglutide Use Linked to Rare Eye Condition NAION in New Study
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A recent study has identified a potential link between the use of GLP-1-targeted diabetes and anti-obesity drug semaglutide, marketed as Wegovy/Ozempic by Novo Nordisk, and a rare ophthalmic condition. Research published in JAMA Ophthalmology revealed that physicians at Harvard and Brigham and Women’s Hospital in Boston discovered an increased risk…
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TowardPi Medical Secures RMB 200 Million in Series D Financing Led by Matrix Partners
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TowardPi (Beijing) Medical Technology Ltd, a Chinese medical technology company, has reportedly secured RMB 200 million in a Series D financing round. The round was led by Matrix Partners, with participation from GTJA Investment and other investors. Established in 2017, TowardPi Medical’s core technical team comprises numerous graduates from Tsinghua…
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StarryGene Initiates Phase I Clinical Trial for XMVA09 Gene Therapy in wAMD
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StarryGene, a biotech company specializing in gene therapy and based in Hefei, China, has announced that the first patient has been dosed in a Phase I clinical study for its gene therapy XMVA09 injection, which is designed to treat wet age-related macular degeneration (wAMD). XMVA09 is positioned as the world’s…
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Kanghong Pharmaceutical’s Lumitin Approved in Myanmar for Neovascular AMD Treatment
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Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773), a Chinese pharmaceutical company, has announced that it has received marketing approval in Myanmar for its product Lumitin (conbercept) for the treatment of neovascular age-related macular degeneration (nAMD). Lumitin, a fusion protein of VEGF receptor and human immunoglobulin Fc segment, is a…
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CGP’s GPN00884 Myopia Drug Enters Phase I Clinical Trial with First Patient Dosed
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced the commencement of a Phase I clinical study for GPN00884, an innovative ophthalmic drug aimed at arresting the progression of childhood myopia, with the first patient now dosed. This randomized, double-blind, placebo-controlled, dose-escalation study is designed to evaluate…
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Cloudbreak Pharma Files for Hong Kong IPO with Focus on Ophthalmic Innovations
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Cloudbreak Pharma Inc., a Cayman Islands-registered pharmaceutical company, has filed for an initial public offering (IPO) on the Hong Kong Stock Exchange, with key details still under wraps. In 2023, the company reported revenues of USD 880,000 and a net loss of USD 129 million, with research and development (R&D)…
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Zhaoke Ophthalmology Partners with China’s Eye Valley to Establish Ophthalmic Research Institute
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), a China-based pharmaceutical company, has announced that its subsidiary, Zhaoke Ophthalmology Ltd (HKG: 6622), has entered into a strategic partnership with China’s Eye Valley. The collaboration aims to develop innovative and generic drugs in the field of ophthalmology and will lead to the establishment…
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MSD to Acquire Ophthalmology Specialist Eyebiotech in a Deal Valued Up to USD 3 Billion
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has entered into an agreement to acquire UK-based ophthalmology specialist Eyebiotech Limited for an upfront payment of USD 1.3 billion, plus potential milestone payments of up to USD 1.7 billion. The deal is anticipated to be finalized in the third quarter of 2024,…
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Hymson Laser’s Mid Infrared Femtosecond Laser Technology Makes Medical Industry Inroads
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Shenzhen-based Hymson Laser Technology Group Co., Ltd (SHA: 688559) has announced a significant breakthrough with the application of its mid-infrared femtosecond laser technology in healthcare. The company has developed a long wave infrared femtosecond laser (LWIRFS) with a wavelength range exceeding 5 μm, marking a global first in its category.…
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Boehringer Ingelheim’s Anti-Sema3A BI 764524 Shows Promise in Diabetic Macular Ischemia Trial
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Boehringer Ingelheim (BI) has announced the publication of results from a Phase I/IIa clinical trial for its anti-Sema3A antibody candidate, BI 764524, used in the treatment of diabetic macular ischemia (DMI), a serious complication of diabetic retinopathy (DR) that can result in blindness. The trial successfully met its primary safety…
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EyePoint Pharmaceuticals’ Durvayu Fails to Meet Primary Endpoint in NPDR Trial
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EyePoint Pharmaceuticals Inc., (NASDAQ: EYPT) has announced that its drug candidate Durvayu (vorolanib intravitreal insert; EYP-1901) did not meet its primary endpoints in the Phase II PAVIA clinical trial for non-proliferative diabetic retinopathy (NPDR). Although the trial data showed some treatment effect, including a reduction in NPDR progression rates at…
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Chengdu Kanghong Pharmaceutical Gets US FDA Nod for Clinical Trial of KH658 for Wet AMD
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Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773), a leading pharmaceutical company based in China, has announced that it has received approval from the US Food and Drug Administration (FDA) to commence clinical trials for its KH658 eye injection. The drug is designed for the treatment of neovascular (wet) age-related…
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Luye Pharma’s Subsidiary Boan Biotech Completes Phase III Trial for Eylea Biosimilar BA9101
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Shandong Boan Biotechnology Co., Ltd., a subsidiary of China-based Luye Pharma Group (HKG: 2186), has achieved a significant milestone with the completion of a Phase III clinical study for its proprietary ophthalmology product BA9101. This biosimilar version of Bayer’s Eylea (aflibercept) targets the treatment of recurrent or metastatic esophageal squamous…
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Viatris Launches Ryzumvi in the US for Rapid Reversal of Pharmacologically-Induced Pupil Dilation
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Viatris Inc. (NASDAQ: VTRS) has launched its alpha-adrenergic blocker Ryzumvi (phentolamine) in the US market, targeting the reversal of pharmacologically-induced pupil dilation caused by adrenergic agonists or parasympatholytic agents. The ophthalmic solution, which received regulatory approval last year, demonstrated in clinical trials that it could reverse eye dilation within 90…
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Regenxbio Reports Stable Visual Acuity Improvements with AbbVie’s Gene Therapy in Wet AMD Trial
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Regenxbio (NASDAQ: RGNX), the development partner for AbbVie’s (NYSE: ABBV) gene therapy ABBV-RGX-314, has announced results from a Phase I/IIa trial focused on wet age-related macular degeneration (wAMD). This announcement complements the preliminary results shared earlier in the year. The 2-year data from the trial indicate that a single administration…
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Intuitive Surgical’s Ion Robotic System Gains Regulatory Approval in China
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Intuitive Surgical (NASDAQ: ISRG), a leading medical robotics firm based in the US, has announced that it has received regulatory approval in China for its Ion surgical robot system. Initially approved in the US in 2019, the Ion system is a robotic-assisted, catheter-based platform designed for minimally invasive biopsy procedures…
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iRegene’s NouvSight001 Gains Orphan Drug Designation for Retinitis Pigmentosa Treatment
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Wuhan-based cell therapy innovator iRegene has secured Orphan Drug Designation (ODD) from the U.S. FDA for its ophthalmic product NouvSight001, aimed at treating retinitis pigmentosa (RP). NouvSight001 is heralded as the world’s first universal ophthalmic cell therapy derived from induced pluripotent stem cells (iPSCs), developed through an innovative “AI+chemical induction”…
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China Grand Pharmaceutical Receives FDA Approval for Post-Surgical Ophthalmic Drug GPN00833
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its hormone nanosuspension eye drops GPN00833 (APP13007), designed for anti-inflammatory and analgesic effects following ophthalmic surgery. Additionally, the company has gained clinical trial…
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Lee’s Pharmaceutical Secures Malaysian Distribution for Generic Glaucoma Treatment
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Lee’s Pharmaceutical Holdings Ltd., (HKG: 0950), a China-based pharmaceutical company, has announced through its subsidiary Zhaoke Ophthalmology Ltd. (HKG: 6622) a distribution and supply agreement with Malaysian pharmaceutical corporation Pharmaniaga. The agreement pertains to Zhaoke’s generic version of AbbVie’s Ganfort, a combination of bimatoprost and timolol maleate eye drops used…
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Formosa Pharmaceuticals Secures FDA Nod for New Steroidal Eye Drug, Set to Launch via Eyenovia
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Taiwan-based Formosa Pharmaceuticals (TPE: 6838) has received approval from the US Food and Drug Administration (FDA) for its new formulation of the steroidal eye drug clobetasol propionate (0.05%), designed to treat post-operative inflammation and pain following ocular surgery. The drug will be commercialized in the US by Eyenovia Inc., (Nasdaq:…
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Bayer Posts 1.2% YOY Sales Decline in 2023 with Pharmaceuticals and Consumer Health Segment Updates
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Germany’s Bayer (ETR: BAYN) has released its financial results for 2023, marking a year of declining sales that culminated in a 1.2% year-on-year (YOY) drop in constant currency and portfolio-adjusted terms, reaching €47.6 billion (USD 51.7 billion). The Pharmaceuticals segment generated €18.1 billion (USD 19.6 billion) with a 0.4% decline…
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Neurophth Biotechnology Completes Enrollment and Dosing in US Clinical Study for ND4-LHON Gene Therapy
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Neurophth Biotechnology Ltd, a leading gene therapy specialist based in China, has announced the completion of patient enrollment and dosing in a Phase I/II clinical study for its investigational drug NR082 (rAAV2-ND4; NFS-01) in the United States. The study targets ND4-mediated Leber’s hereditary optic neuropathy (ND4-LHON). The single-arm, multi-center Phase…
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Innovent Biologics’ IBI311 Achieves Primary Endpoint in Phase III Study for Thyroid Eye Disease
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Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, has announced that its Phase III regulatory study in China for IBI311, a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody, has successfully achieved its primary endpoint. The study targeted thyroid eye disease (TED), with a New Drug Application…
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ChinaGene Secures CDE Approval for ZVS101e Gene Therapy Targeting Retinitis Pigmentosa
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Beijing-based ChinaGene Technology Co., Ltd. has announced that it has received tacit clinical approval from the Center for Drug Evaluation (CDE) for its ophthalmic gene therapy ZVS101e, designed to treat retinitis pigmentosa (RP) patients with the RHO-R135W (RHO c.403C>T) mutation. This follows a tacit trial approval granted in the United…
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Roche’s Faricimab Shows Sustained Vision Benefits in Phase III Study for Retinal Vein Occlusion
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Swiss pharmaceutical giant Roche (SWX: ROG) has released interim Phase III data for its bispecific antibody (BsAb) Vabysmo (faricimab) in the treatment of macular edema resulting from branch and central retinal vein occlusion (BRVO and CRVO). The biologic demonstrated significant vision improvements, with gains of 17 to 19 letters on…
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J&J’s Gene Therapy for X-linked Retinitis Pigmentosa Receives CDE Nod for Breakthrough Designation
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The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson (J&J, NYSE: JNJ)’s AAV5-hRKp.RPGR (JNJ-5340, botaretigene sparoparvovec) intraocular injectable solution is on track to receive breakthrough therapy designation (BTD). This product, an adeno-associated virus vector (AAV) based gene therapy co-developed with MeiraGTx Holdings plc, is aimed at…
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Roche Posts Modest 2023 Growth Amid Shifts in Demand for COVID-Related Products
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Swiss pharmaceutical giant Roche (SWX: ROG) has published its 2023 financial results, showing a modest 1% year-on-year (YOY) increase in global sales at constant exchange rates (CER) to CHF 58.7 billion (USD 68.5 billion). This growth was primarily due to a 6% YOY expansion in the pharmaceutical business to CHF…
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Zhaoke Ophthalmology Strikes Distribution Deal with South Korea’s Kwangdong Pharmaceutical for Brimochol PF
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), a China-based pharmaceutical company, through its subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622), has announced a distribution and supply agreement with South Korea’s Kwangdong Pharmaceutical Co., Ltd. The agreement pertains to Brimochol PF, a preservative-free fixed dose of carbachol and bromonidine tartrate, which serves as…
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Formosa Pharmaceuticals Strikes Licensing Deal with Cristália for Ocular Surgery Pain Treatment in Brazil
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Taiwan-based Formosa Pharmaceuticals (TPE: 6838) has announced the signing of a licensing agreement with Brazil-based Cristália Produtos Quimicos Farmaceuticos Ltda. According to the agreement, Formosa will grant Cristália the commercialization rights for its product candidate APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%) in Brazil, which is being developed as a potential…
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Zhaoke Ophthalmology Secures NMPA Approval for Presbyopia Treatments Brimochol PF and CarbacholPF
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), a China-based pharmaceutical company, through its subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622), has announced receiving clinical trial approvals from the National Medical Products Administration (NMPA) for two of its products, Brimochol PF and CarbacholPF, which are designed to treat presbyopia. Brimochol PF and Carbachol…
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Sandoz Strikes Deal to Acquire Coherus Biosimilar for Ophthalmic Treatment
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Swiss pharmaceutical company Sandoz (SWX: SDZ) has entered into an agreement to purchase Cimerli (ranibizumab), a biosimilar referencing Roche (SWX: RO) unit Genentech’s Lucentis, from US-based Coherus Biosciences (NASDAQ: CHRS). This transaction, valued at a USD 170 million upfront payment, is anticipated to conclude in the first half of 2024.…
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Regenxbio’s One-Time Gene Therapy for Wet AMD Shows Promise in Phase II Study
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Gene therapy specialist Regenxbio (NASDAQ: RGNX) has announced preliminary results from a Phase II study for ABBV-RGX-314, a VEGF pathway inhibitor developed in partnership with AbbVie (NYSE: ABBV) for the treatment of wet age-related macular degeneration (wet AMD). The therapy is designed to be administered as a one-time injection, aiming…
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Ocumension Therapeutics Sells $56.66 Million Stake in EyePoint Pharmaceuticals
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Ocumension Therapeutics (HKG: 1477), a specialist in the ophthalmology sector in China, has announced plans to sell 2,910,501 shares of EyePoint Pharmaceuticals Inc., (NASDAQ: EYPT), representing a 5.96% stake in the US company. The transaction is expected to generate proceeds of USD 56.66 million (HKD 443 million). EyePoint Pharmaceuticals, established…
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Roche’s Phesgo and Faricimab Receive NMPA Approvals for Breast Cancer and nAM
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The National Medical Products Administration (NMPA) has granted separate approvals for two distinct drugs from Swiss pharmaceutical giant Roche (SWX: ROG). The first approval is for Phesgo (trastuzumab, pertuzumab), indicated for the treatment of HER2-positive early and metastatic breast cancer. The second approval is for faricimab, which targets neovascular age-related…
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Roche Receives NMPA Approval for Ophthalmology BsAb Vabysmo (Farcimab) for Diabetic Macular Edema
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced that it has obtained marketing approval from China’s National Medical Products Administration (NMPA) for its ophthalmology bispecific antibody (BsAb) Vabysmo (faricimab), which is indicated for the treatment of diabetic macular edema (DME). Vabysmo targets both vascular endothelial growth factor A (VEGF-A) and…
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Oculotronics Secures Pre-Series A Funding for Ophthalmic Surgical Robotics
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Oculotronics, a Guangzhou-based developer of ophthalmic surgical robots, has reportedly raised tens of millions of renminbi in a pre-Series A financing round. The funds raised will be allocated towards the clinical study and industrialization of its flagship product, a micron-level high-precision ophthalmic surgical robot. Additionally, the capital will support the…
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VivaVision Biotech Inc. Receives FDA Approval for VVN461 Phase II Clinical Trial
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China’s VivaVision Biotech Inc. has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase II clinical trial for its in-house developed drug candidate, VVN461. The trial will assess the efficacy of VVN461 as a treatment for inflammation following cataract surgery. VVN461’s…
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Ji Xing Pharmaceuticals Partners with WuXi STA for Sterile Nasal Spray Production
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Shanghai-based Ji Xing Pharmaceuticals, backed by RTW Investments, has formed a strategic partnership with WuXi STA, a subsidiary of WuXi AppTec (HKG: 2359, SHA: 603259), to establish a sterile nasal spray production line. This collaboration aims to leverage the strengths of both companies, with the new production facility set to…
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Innovent Biologics Presents Positive Clinical Results for Efdamrofusp Alfa and IBI324 at AAO
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Innovent Biologics, Inc. (HKG: 1801), a China-based biopharmaceutical company, has published the latest clinical results for its two drug candidates, efdamrofusp alfa (IBI302) and IBI324, at the American Association of Ophthalmology (AAO) meeting. IBI302 is a recombinant fully human anti-VEGF and anti-complement bispecific fusion protein, while IBI324 is a bispecific…
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AbbVie Secures Option Agreement with Aldeyra Therapeutics for RASP Modulator Reproxalap
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AbbVie (NYSE: ABBV) has entered into an option agreement with Aldeyra Therapeutics (NASDAQ: ALDX), a US-based biopharmaceutical company, to acquire a development, manufacturing, and commercialization license for the reactive aldehyde species (RASP) modulator, reproxalap. The agreement grants AbbVie co-exclusive rights in the US and exclusive rights in all other territories…
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Roche’s Vabysmo Receives FDA Approval for Macular Edema Treatment Following RVO
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Swiss pharmaceutical giant Roche (SWX: ROG) announced last week that it has received an indication extension approval from the US Food and Drug Administration (FDA) for its bispecific antibody (BsAb) Vabysmo (faricimab) to treat macular edema following retinal vein occlusion (RVO). This approval broadens the therapeutic applications of Vabysmo, which…
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China Grand Pharma Initiates Phase III Trial for GPN00833 in Cataract Surgery Recovery
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced a significant milestone in the clinical development of GPN00833, with the first patient enrolled and dosed in a Phase III study. This multi-center, randomized, double-blinded, placebo-controlled, parallel group study is designed to assess the efficacy and safety of…
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Skyline Therapeutics Gains NMPA Approval for SKG0106 in Neovascular AMD Treatment
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Skyline Therapeutics has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative drug SKG0106, an intraocular injection solution for the treatment of neovascular age-related macular degeneration (nAMD). Innovative Gene Therapy MechanismSKG0106 is a recombinant adeno-associated virus (rAAV) gene therapy drug, utilizing…
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Lee’s Pharmaceutical’s Subsidiary Announces Positive Results for Myopia Treatment NVK002
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), through its subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622), has announced positive topline results from the Phase III mini CHAMP study for NVK002, an atropine external use eye solution developed to address myopia progression. Study Design and ParticipantsThe Phase III mini CHAMP study was…
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AffaMed Technologies Secures Exclusive Rights to SIFI’s Intraocular Lens Products in Greater China
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AffaMed Technologies, a joint venture between China’s AffaMed Therapeutics and Italy-based SIFI S.p.A., has announced a significant licensing agreement with the SIFI Group. This deal grants AffaMed exclusive rights to manufacture, develop, and commercialize SIFI’s range of intraocular lens (IOL) products in the Greater China region. The financial details of…
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Boehringer Ingelheim Collaborates with Zeiss Medical Technology on Retinal Disease Detection
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Germany’s Boehringer Ingelheim (BI) has entered into a collaboration agreement with fellow German firm Zeiss Medical Technology to advance early detection and vision loss prevention methods for serious retinal diseases. While financial details of the agreement remain undisclosed, the partnership aims to leverage cutting-edge technology in ophthalmology. Harnessing AI for…
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Zhaoke Ophthalmology Completes Patient Enrollment for Phase III Trials of TAB014 and Epinastine
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Zhaoke Ophthalmology Ltd (HKG: 6622), a former subsidiary of Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), has announced the successful completion of patient enrollment for two separate Phase III clinical studies: one for TAB014 and another for epinastine, a generic version of Allergan’s Elestat. This milestone underscores Zhaoke’s commitment to advancing…
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AffaMed Therapeutics’ Luminate Receives Clinical Trial Approval for Dry AMD in China
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AffaMed Therapeutics, a China-based biotech firm, has announced the receipt of its first clinical trial approval in China for its pipeline candidate, Luminate (risuteganib; AM011). This development marks a significant milestone for the company, which acquired the Greater China manufacturing, development, and commercial rights to risuteganib from Hanmi Pharmaceutical, a…
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Tianjin Century Kangtai Biomedical Raises Hundreds of Millions in Series A+ and B Financings
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Tianjin Century Kangtai Biomedical Engineering Co., Ltd, a China-based company, has reportedly secured hundreds of millions of renminbi through Series A+ and Series B financing rounds. The Series B round was led by SDIC, with participation from Efung Capital, Lake VC, Morning Spring Venture, and Jinju Capital. The funds raised…
