Showing 3051-3060 of 5771 results for "".
- Karen Petrou Appointed Board Chair of the Foundation Fighting Blindnesshttps://modernod.com/news/karen-petrou-appointed-board-chair-of-the-foundation-fighting-blindness/2482334/The Foundation Fighting Blindness announced the appointment of Karen Petrou as Board Chair, effective July 1, 2024. Petrou succeeds David Brint, who is retiring after 8 years of service. Ms. Petrou’s becomes the third person to hold the position in the Foundation&rs
- FDA Grants DeNovo Classification to Balance Ophthalmics' FYSX Ocular Pressure Adjusting Pumphttps://modernod.com/news/fda-grants-denovo-classification-to-balance-ophthalmics-fysxtm-ocular-pressure-adjusting-pump/2482333/Balance Ophthalmics announced that the FDA has granted DeNovo Classification of the FYSX Ocular Pressure Adjusting Pump, a new category of treatment for patients with normal tension glaucoma (NTG) and open-angle glaucoma (OAG) with IOP ≤ 21 mmHg. “The FDA classif
- Rayner Closes Recruitment for IDE for RayOne EMV Toric IOLshttps://modernod.com/news/rayner-closes-recruitment-for-ide-for-rayone-emv-toric-iols/2482332/Rayner announced that it has closed recruitment in the investigational device exemption (IDE) study for its EMV Toric IOL in the US. The study will ultimately enable the introduction of the RayOne EMV Toric lens for use in the US. Developed in collaboration with Professor
- 4DMT Receives FDA Clearance of IND Application for 4D-175 Genetic Medicine for the Treatment of GAhttps://modernod.com/news/4dmt-receives-fda-clearance-of-ind-application-for-4d-175-genetic-medicine-for-the-treatment-of-ga/2482330/4D Molecular Therapeutics announced FDA clearance of its investigational new drug application (IND) for 4D-175, an R100 vector-based intravitreal genetic medicine for the treatment of patients with geographic atrophy (GA). The phase 1 GAZE clinical trial will assess 4D-175 in
- FDA Clears Alcon's Unity Vitreoretinal-Cataract System and Standalone Cataract Systemhttps://modernod.com/news/fda-clears-alcons-unity-vitreoretinal-cataract-system-and-unity-standalone-cataract-system/2482329/Alcon announced that its Unity Vitreoretinal Cataract System (VCS) and Unity Cataract System (CS) have received FDA 510(k) clearance. The new devices are the first to be introduced from Alcon’s Unity portfolio and represent Alcon's next generation of e
- Ikerian Receives EU-MDR Certificate for Four Devices, its Ophthalmology Data Platform and AI Modelshttps://modernod.com/news/ikerian-receives-eu-mdr-certificate-for-four-devices-its-ophthalmology-data-platform-and-ai-models/2482328/Ikerian announced it has received a European Union Medical Device Regulation (EU-MDR) certificate as Class IIa medical devices for its RetinAI Discovery digital data platform, as well as AI-based models to identify and quantify retinal layers
- Ocugen Doses First Patient in Phase 3 Clinical Trial for OCU400 Gene Therapy for RPhttps://modernod.com/news/ocugen-doses-first-patient-in-phase-3-clinical-trial-for-ocu400-gene-therapy-for-retinitis-pigmentosa/2482326/Ocugen announced that the first patient has been dosed in its phase 3 liMeliGhT clinical trial for OCU400, a modifier gene therapy product candidate being developed for retinitis pigmentosa (RP). “Each clinical milestone achieved by OCU400 brings us closer to providing a one-
- Harrow Provides Triesence Relaunch Updatehttps://modernod.com/news/harrow-provides-triesence-relaunch-update/2482325/Harrow has announced the manufacture of the first of three commercial-scale process performance qualification (PPQ) batches of Triesence (triamcinolone acetonide injectable suspension) 40 mg/mL, a preservative-free synthetic corticosteroid that is FDA‑approved for visualization during vitrec
- J&J's Nipocalimab Significantly Improves Sjögren’s Disease Activity in a Phase 2 Studyhttps://modernod.com/news/jjs-nipocalimab-significantly-improves-sjogrens-disease-activity-in-a-phase-2-study/2482323/Johnson & Johnson announced that patients treated with nipocalimab demonstrated statistically significant (P=0.002) and clinically meaningful improvement in ClinESSDAIa score versus placebo at 24 weeks compared to baseline (primary endpoint) in the phase 2 DAHLIAS dose-rang
- EyeCare Partners Names New Members to Executive Leadership Teamhttps://modernod.com/news/eyecare-partners-names-new-members-to-executive-leadership-team/2482321/EyeCare Partners announced new additions and changes to its executive leadership team. Appointments and changes are: Andrew Hardesty has been promoted to the new role of Chief Program Officer, effective immediately. This role oversees and lea