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Clearside Biomedical Publishes SCS Delivery Guidelines
Clearside Biomedical has taken a significant step forward in the field of ophthalmology by publishing new guidelines for suprachoroidal space (SCS) injection, a technique used to deliver medication directly to the back of the eye. These guidelines have been featured…
China Grants Priority Review for Innovent’s TED Treatment NDA
Innovent Biologics announced that its New Drug Application (NDA) for their recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody, IBI311, has been accepted and granted priority review designation by the Center for Drug Evaluation (CDE) of the China National Drug…
FDA Approves Biocon Biologics’ Yesafili™
Biocon Biologics today announced that the US FDA has approved the Company’s first-to-file application for Yesafili™ (aflibercept-jbvf), an interchangeable biosimilar aflibercept. Indications and Uses of YESAFILI YESAFILI, a vascular endothelial growth factor (VEGF) inhibitor used to treat several ophthalmology conditions,…
Wayne State University Secures Grant for Diabetes Eye Study
Dr. Fu-Shin Yu, a professor of Ophthalmology, Visual and Anatomical Sciences at Wayne State University School of Medicine, has been awarded a significant grant from the National Eye Institute of the National Institutes of Health. The five-year grant, totaling $2,167,882,…
FDA Approves Glenmark’s Ophthalmic Solution for Glaucoma
Glenmark Pharmaceuticals has received final approval by the FDA for Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%|0.5% for glaucoma treatment. This solution has been recognized by the FDA as bioequivalent and therapeutically equivalent to Combigan® Ophthalmic Solution, 0.2%|0.5% by…
FDA Grants De Novo Authorization for Scanly Home OCT Device
Notal Vision announced that the FDA has granted De Novo authorization for its patient self-operated Scanly Home OCT device. Designated by the FDA as a breakthrough device for patients suffering from wet age-related macular degeneration (AMD), Scanly Home OCT aims…
Arcan’s Insight® 100 Ultrasound Approved in China
ArcScan, a global medical technology company dedicated to revolutionizing ophthalmic care, marked a significant milestone with the announcement of the National Medical Products Administration (NMPA) approval of its flagship product, the ArcScan Insight® 100, for use in China. Addressing the…
Humonix Biosciences Appoints Karen Torrejon, PhD as CEO
Humonix Biosciences, a pioneering biotechnology company, has recently named Dr. Karen Torrejon as its new Chief Executive Officer. Dr. Torrejon, who originally founded the company in 2014, will now lead its operations as it transitions into a broader, science-driven platform.…
EyeCRO Unveils Clinical Data for MiDROPS Technology
EyeCRO recently announced the results from the inaugural clinical application of its MiDROPS (Microemulsion Drug Ocular Penetration System) technology, presented by Telios Pharma at the Association for Research in Vision and Ophthalmology (ARVO) meeting held in Seattle, WA. The presentation,…
Oculis Finalizes Phase 2 Trial Enrollment for OCS-05 in AON
Oculis has completed enrollment in its multicenter, randomized, double-blind, placebo-controlled phase 2 ACUITY trial evaluating the safety and tolerability of OCS-05 in patients with Acute Optic Neuritis (AON). Topline results are expected in Q4 2024. The phase 2 ACUITY study…