Showing 1251-1260 of 1484 results for "".
- FDA Accepts DORC’s Orphan-Drug Designation Application for Trypan Blue and Brilliant Blue Ghttps://modernod.com/news/fda-accepts-dorcs-orphan-drug-designation-application-for-trypan-blue-and-brilliant-blue-g/2481740/DORC has has received notification from the FDA that their application for orphan drug designation for a dual combination of Trypan Blue and Brilliant Blue G ophthalmic solutions has been granted. DORC's MembraneBlue-Dual ILM and ERM stain has been used in more than 500,00
- FDA Clears CorNeat EverPatch, World's First Non-Degradable, Synthetic Tissue Substitute for Ophthalmic Surgeryhttps://modernod.com/news/fda-clears-corneat-everpatch-worlds-first-non-degradable-synthetic-tissue-substitute-for-ophthalmic-surgery/2481668/The FDA has granted 510(k) clearance to CorNeat Vision's EverPatch, which the company describes as the first synthetic, non-degradable tissue-integrating matrix for use in ophthalmic surgeries. It is composed of a non-woven, polymer matrix which integrates with surrounding tissue an
- Nova Eye Medical Announces US Market Clearance of the iTrack Advance Canaloplasty Devicehttps://modernod.com/news/nova-eye-medical-announces-us-market-clearance-of-the-itrack-advance-canaloplasty-device/2481530/Nova Eye Medical announced that it has been granted FDA 510(k) clearance for its new canaloplasty device, iTrack Advance. The iTrack Advance has been cleared for microcatheterization and viscodilation to reduce IOP in adult patients with prim
- Kala Receives FDA Fast Track Designation for Human MSC-S Therapy for Persistent Corneal Epithelial Defecthttps://modernod.com/news/kala-pharmaceuticals-receives-fda-fast-track-designation-for-kpi-012-a-human-msc-s-therapy-for-persistent-corneal-epithelial-defect/2481526/The FDA has granted Fast Track designation for Kala Pharmaceuticals' human mesenchymal stem cell secretome (MSC-S) therapy (KPI-012) for the treatment of persistent corneal epithelial defect (PCED). “There is a significant unmet need for patients suffering from PCED, whic
- Pixium Vision Announces FDA Breakthrough Device Designation for the Prima System in Dry AMDhttps://modernod.com/news/pixium-vision-announces-fda-breakthrough-device-designation-for-the-prima-system-in-dry-amd/2481505/The FDA has granted Breakthrough Device Designation to Pixium Vision's Prima System, a photovoltaic substitute of photoreceptors providing simultaneous use of the central prosthetic and peripheral natural vision implanted in human patients with atrophic dry age-related macular
- Théa Open Innovation and Galimedix Partner to Develop and Commercialize GAL-101 for Ophthalmic Indicationshttps://modernod.com/news/thea-open-innovation-and-galimedix-partner-to-develop-and-commercialize-gal-101-for-ophthalmic-indications/2481497/Théa Open Innovation and Galimedix Therapeutics announced that they have signed a licensing agreement in which Galimedix will grant Théa exclusive rights for the development and commercialization of GAL-101, Galimedix’s lead disease-modifying compound, for the topical and
- RxSight Announces Pricing of Public Offering of Common Stockhttps://modernod.com/news/rxsight-announces-pricing-of-public-offering-of-common-stock/2481395/RxSight, maker of the RxSight Light Adjustable Lens system, announced it has priced its underwritten public offering. RxSight expects to sell 4 million shares of its common stock at a price to the public of $12.50 per share. RxSight has granted the underwriter a 30-day op
- Endogena Therapeutics Receives FDA Fast Track Designation for EA-2353 for the Treatment of Retinitis Pigmentosahttps://modernod.com/news/endogena-therapeutics-receives-fda-fast-track-designation-for-ea-2353-for-the-treatment-of-retinitis-pigmentosa/2481387/The FDA has granted Fast Track designation to Endogena Therapeutics' EA-2353 for the treatment of retinitis pigmentosa (RP). EA-2353 takes a novel, small-molecule approach and selectively activates endogenous retinal stem and progenitor cells, which differentiate into
- Eyenuk Secures the First European Union MDR Certification for Autonomous AI Detection of DR, AMD, and Glaucomahttps://modernod.com/news/eyenuk-secures-the-first-european-union-mdr-certification-for-autonomous-ai-detection-of-diabetic-retinopathy-amd-and-glaucoma/2481377/Eyenuk has been approved to market its EyeArt AI eye screening system in the European Union for the new uses of detecting age-related macular degeneration (AMD) and glaucomatous optic nerve damage. The EyeArt AI system (version 3.0) has been granted a new European Commiss
- Ocugen Announces OCU400 Receives Orphan Drug Designations for Retinitis Pigmentosa and Leber Congenital Amaurosishttps://modernod.com/news/ocugen-announces-ocu400-receives-orphan-drug-designations-for-retinitis-pigmentosa-and-leber-congenital-amaurosis/2481300/Ocugen announced that the FDA granted orphan drug designations to OCU400—human nuclear hormone receptor subfamily 2 group E member 3 (hNR2E3)—for the treatment of retinitis pigmentosa (RP) and Leber congenital amaurosis (LCA). “Receiving orphan drug designation is