Showing 1791-1800 of 2150 results for "".
- Astellas Withdraws European Application for Avacincaptad Pegol for GAhttps://modernod.com/news/astellas-withdraws-european-application-for-investigational-geographic-atrophy-treatment/2482517/Astellas Pharma announced it is withdrawing its marketing authorization application for avacincaptad pegol (ACP) from the European Medicines Agency (EMA). ACP, an investigational intravitreal treatment designed to inhibit the complement C5 protein, was developed for geographic atrophy (
- Aviceda Completes Enrollment for Phase 2b SIGLEC Study for Geographic Atrophy Treatmenthttps://modernod.com/news/aviceda-completes-enrollment-for-phase-2b-siglec-study-for-geographic-atrophy-treatment/2482456/Aviceda Therapeutics announced the completion of patient enrollment for its phase 2b SIGLEC study. The trial is comparing the safety and efficacy of the company's lead candidate, AVD-104, with avacincaptad pegol (marketed as Izervay) for the treatment of geographic atrophy (GA) secondary to a
- Lumibird Unveils Omnicad Imaging Platform for Ocular Surface Diseasehttps://modernod.com/news/lumibird-unveils-omnicad-imaging-platform-for-ocular-surface-disease/2482453/Lumibird Medical announced the launch of the Omnicad, an imaging platform equipped with integrated AI algorithms designed to aid in the diagnosis of ocular surface disease (OSD). The device, exclusively available in the US market, aims to address the needs of optometrists and ophthalmol
- CHMP Upholds Negative Opinion for Apellis' Pegcetacoplan for GA in the EU Following Re-Examinationhttps://modernod.com/news/chmp-upholds-negative-opinion-for-apellis-pegcetacoplan-for-geographic-atrophy-in-the-eu-following-re-examination/2482450/Apellis Pharmaceuticals announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has upheld its previous June 2024 negative opinion on the marketing authorization application for geographic atrophy (GA) treatment pegcetacoplan.
- Microsurgical Technology (MST) Announces Global Partnership with Vista Ophthalmicshttps://modernod.com/news/microsurgical-technology-mst-announces-global-partnership-with-vista-ophthalmics/2482446/Microsurgical Technology (MST) announced an exclusive global partnership with ophthalmic device company Vista Ophthalmics that will introduce Vista Ophthalmics' products—Vista 1-Step and Vista IS—to the global market. Financial terms of the deal were not disclosed.
- Samsara Vision Promotes Jason Herod to Chief Commercial Officerhttps://modernod.com/news/samsara-vision-promotes-jason-herod-to-chief-commercial-officer/2482421/Samsara Vision announced that Jason Herod, formerly Vice President Commercial, International Markets, has been promoted to Chief Commercial Officer (CCO), effective August 15, 2024. Mr. Herod joined Samsara Vision in August 2021, bringing with him over 24 years of extensive experi
- Lupin Receives Tentative FDA Approval for Generic Version of Lumifyhttps://modernod.com/news/lupin-receives-tentative-fda-approval-for-generic-version-of-lumify/2482400/India-based generic drug maker Lupin has received tentative approval from the FDA for its abbreviated new drug application (NDA) for brimonidine tartrate ophthalmic solution 0.025% to market a generic equivalent of Lumify ophthalmic solution 0.025% (Bausch + Lom
- Novaliq Receives Positive CHMP Opinion for Vevizye in Dry Eye Diseasehttps://modernod.com/news/novaliq-receives-positive-chmp-opinion-for-vevizye-in-dry-eye-disease/2482383/Novaliq announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a marketing authorization in the European Union for dry eye drug Vevizye. Vevizye is intended for the treatment
- Outlook Therapeutics Receives UK Approval of Lytenava for the Treatment of Wet AMDhttps://modernod.com/news/outlook-therapeutics-receives-uk-approval-of-lytenava-for-the-treatment-of-wet-amd/2482350/Outlook Therapeutics announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Lytenava (bevacizumab gamma), an ophthalmic formulation of bevacizumab for the treatment of wet AMD. Lytenava is the first and only aut
- Vabysmo Receives CHMP Recommendation for RVO Indicationhttps://modernod.com/news/roches-vabysmo-gets-chmp-recommendation-for-rvo-indication/2482337/Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the extension of Vabysmo (faricimab) marketing authorization to include the treatment of visual impairment caused by macular edema secondary to retin