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Opthea Completes Enrollment in Wet AMD Phase 3 Trials
Opthea Limited announced the completion of enrollment in both the COAST and ShORe trials, constituting its pivotal Phase 3 clinical program. This program is designed to assess the safety and superior efficacy of sozinibercept in combination with standard-of-care anti-VEGF-A therapies…
Exonate Adds Dr. Rafiq Hasan to Leadership Team
Exonate announced the expansion of its Board with the appointment of Dr. Rafiq Hasan as Non-Executive Director. This strategic move aims to bolster the company’s expertise in ophthalmology, particularly within the diabetic eye disease sector, as it advances its lead…
Pegcetacoplan’s Role in Retinal Atrophy Treatment
Researchers from the National Institute for Health Research Biomedical Research Centre at Moorfields Eye Hospital and University College London Institute of Ophthalmology, London have conducted a post hoc analysis of data from two phase 3 clinical trials of pegcetacoplan (Syfovre,…
Outlook Therapeutics Seeks UK Approval for Wet AMD Drug
Outlook Therapeutics announced the submission of its Marketing Authorisation Application (MAA) to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) in a press release. The MAA is for bevacizumab gamma (ONS-5010/LYTENAVA), its investigational formulation of bevacizumab for the…
Rezolute’s Phase 2 Success with Oral DME Drug
Rezolute announced promising topline results from its Phase 2 clinical study of RZ402. This study targeted patients with diabetic macular edema (DME) who were either naïve to or had limited exposure to anti-vascular endothelial growth factor (anti-VEGF) injections. Monumental Results…
KDB GLIDE FDA 510(k) Clearance for Expanded Glaucoma Use
New World Medical announced a significant milestone with the receipt of 510(k) indication expansion from the U.S. Food and Drug Administration (FDA) for KDB (Kahook Dual Blade) GLIDE. This clearance allows for the reduction of intraocular pressure (IOP) in adult…
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,…
Resin Technology Could Improve 3D Printing of Intraocular Devices
Researchers at the University of East Anglia (UEA) have developed a novel resin suitable for 3D printing intraocular devices. This pioneering innovation holds the potential to revolutionize the production of eye implants, which are crucial for cataract and refractive surgeries,…