Showing 7081-7090 of 8649 results for "".
- 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
- Spryte Medical Receives Breakthrough Device Designation from FDA for Neuro OCT Technologyhttps://modernod.com/news/spryte-medical-receives-breakthrough-device-designation-from-fda-for-neuro-optical-coherence-tomography-noct-technology/2482373/Spryte Medical announced that its neuro Optical Coherence Tomography (nOCT) technology has been granted Breakthrough Device Designation by the FDA. This recognition underscores the potential of nOCT in neurointervention and cerebrovascular treatment. The FDA’s
- Oertli Receives FDA 510(k) Clearance for Faros Surgical Systemhttps://modernod.com/news/oertli-instrumente-ag-achieves-milestone-with-fda-510k-clearance-for-faros-surgical-system/2482371/Oertli Instrumente announced it has received FDA 510(k) clearance for the Faros anterior cataract surgery system. According to a company news release, the Faros system offers a compact design and rapid operational readiness, requiring minimal space in operating rooms. It
- New Data for Susvimo Demonstrates Sustained Efficacy in DME and DRhttps://modernod.com/news/new-data-for-susvimo-demonstrates-sustained-efficacy-in-dme-and-dr/2482365/Genentech and Roche announced 2-year data from the phase 3 Pagoda and Pavilion studies evaluating Susvimo (ranibizumab injection) 100 mg/mL for the treatment of diabetic macular edema (DME) and diabetic retinopathy (DR), respectively. Susvimo, which is being
- Vabysmo Showed Extended Durability, Continued Efficacy and a Consistent Safety Profile in Long-Term DME Studyhttps://modernod.com/news/vabysmo-showed-extended-durability-continued-efficacy-and-a-consistent-safety-profile-in-long-term-dme-study/2482363/At the American Society of Retina Specialists (ASRS) 2024 Annual Meeting in Stockholm, Sweden, Genentech announced new, 4-year data from the RHONE-X extension study. The study met all primary endpoints, showing that Vabysmo (faricimab-svoa) was well tolerated in people with diabetic mac
- Perry J. Sternberg Joins Sydnexis as Chief Executive Officerhttps://modernod.com/news/perry-j-sternberg-joins-sydnexis-as-chief-executive-officer/2482358/Sydnexis has announced the appointment of Perry J. Sternberg as Chief Executive Officer and a member of the Board of Directors. Mr. Sternberg is a pharma/biotech executive with more than 30 years in the industry and 15 years in eye care. Immediately prior to joining Sydnexis,
- Okyo Pharma to Initiate Neuropathic Corneal Pain Trial for OK-101https://modernod.com/news/okyo-pharma-to-initiate-neuropathic-corneal-pain-trial-for-ok-101/2482353/Okyo Pharma announced its plan to advance OK-101 into a phase 2 clinical trial of neuropathic corneal pain which is expected to begin in Q3 2024. This 1-year study is supported by preclinical animal model data and statistically significant pain relief observe
- Hospital in Poland is First Teaching Institution to Use Haag-Streit's Eyesi Indirect Ophthalmoscope ROP Simulatorshttps://modernod.com/news/hospital-in-poland-is-first-teaching-institution-to-use-haag-streits-eyesi-indirect-ophthalmoscope-rop-simulators/2482352/Haag-Streit announced it has enabled trainee ophthalmologists across Poland to become competent in the skills required for effective ROP examination in a lifelike, yet risk-free, environment. The University Clinical Hospital, Poland, will be the first teaching institution globally to use four Eye
- EyeSouth Partners Unveils Clinical Research Divisionhttps://modernod.com/news/eyesouth-partners-unveils-clinical-research-division/2482345/EyeSouth Partners has announced the expansion of
- CDRH Expands TAP Program to Include Ophthalmic Deviceshttps://modernod.com/news/cdrh-expands-tap-program-to-include-ophthalmic-devices/2482344/Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health (CDRH), announced the continued expansion of the Total Product Life Cycle (TPLC) Adv