Showing 5371-5380 of 5771 results for "".
- Interface Biologics Completes Pre-IND Meeting with FDA on Epidel Technology for Treatment of Posterior Inflammatory Eye Diseaseshttps://modernod.com/news/interface-biologics-completes-pre-ind-meeting-with-fda-on-epidel-technology-for-treatment-of-posterior-inflammatory-eye-diseases/2479645/Interface Biologics has announced a positive pre-investigational new drug meeting with the FDA for its dexamethasone intravitreal implant for the treatment of posterior inflammatory eye diseases. The FDA concurred with IBI’s manufacturing and clinical development plans, based on the precl
- AcuFocus Receives IDE Approval from the FDA to Begin Clinical Study of the IC-8 Lenshttps://modernod.com/news/acufocus-receives-ide-approval-from-the-fda-to-begin-clinical-study-of-the-ic-8-lens/2479646/AcuFocus announced that it has received approval for an investigational device exemption (IDE) from the FDA to conduct a pivotal study of the company’s IC-8 small aperture IOL for patients with cataracts. The AcuFocus IC-8 IOL is a clear monofocal lens with an embedded mini-ring or pinhole
- FDA Approves Genentech’s ACTPen, the Actemra Autoinjector, for Giant Cell Arteritis, Other Indicationshttps://modernod.com/news/fda-approves-genentechs-actpen-the-actemra-autoinjector-for-giant-cell-arteritis-other-indications/2479647/Genentech announced that the FDA has approved ACTPen 162 mg/0.9 mL, a single-dose prefilled autoinjector for Actemra (tocilizumab), as an additional formulation for adult patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-m
- Eyenovia Initiates Phase 3 MicroStat Program for Pharmacologic Mydriasis: Enrolls First Patient in MIST-1 Studyhttps://modernod.com/news/eyenovia-initiates-phase-3-microstat-program-for-pharmacologic-mydriasis-enrolls-first-patient-in-mist-1-study/2479648/Eyenovia announced that it has enrolled the first patient in the first of two phase 3 trials (MIST-1 and MIST-2) of the company’s MicroStat program for pharmacologic mydriasis. The studies will investigate the safety and efficacy of the company’s first-in-class fixed-combination p
- Gene Therapy Luxturna Approved in EU to Restore Vision in People With Rare Inherited Retinal Diseasehttps://modernod.com/news/gene-therapy-luxturna-approved-in-eu-to-restore-vision-in-people-with-rare-inherited-retinal-disease/2479651/Novartis announced that the European Commission (EC) approved Luxturna, a one-time gene therapy for the treatment of patients with vision loss due to a genetic mutation in both copies of the RPE65 gene and who have enough viable retinal cells. The authorization is valid in all 28 member st
- Takeda Gains Clearance from European Commission for Shire Purchasehttps://modernod.com/news/takeda-gains-clearance-from-european-commission-for-shire-purchase/2479653/Takeda announced Tuesday that it received clearance from the European Commission for its proposed $62-billion acquisition of Shire, with the condition that Takeda sells its experimental anti-integrin agent SHP647 and certain associated rights. Takeda said it expects SHP647 “to attract inter
- Permanent J Code Issued for Avedro’s Photrexa Drug Formulationshttps://modernod.com/news/permanent-j-code-issued-for-avedros-photrexa-drug-formulations/2479654/Avedro announced that the Centers for Medicare and Medicaid Services (CMS) issued a product-specific J code, J2787, for Photrexa Viscous (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) and Photrexa (riboflavin 5’-phosphate ophthalmic solution). These Photrexa formulations are the onl
- Georgia Eye Associates Affiliates with EyeSouth Partnershttps://modernod.com/news/georgia-eye-associates-affiliates-with-eyesouth-partners/2479657/EyeSouth Partners has announced that it has completed a strategic partnership with Georgia Eye Associates, expanding its presence into the Lawrenceville and northeast Atlanta regions. EyeSouth is an eye care-focused physician services organization formed by Shore Capital Partners, a leading lower
- Restoring Sight: Clinical Progress Toward Australia’s Bionic Eyehttps://modernod.com/news/restoring-sight-clinical-progress-towards-australias-bionic-eye/2479658/Bionic Vision Technologies (BVT) announced medical researchers had successfully restored a sense of vision in four blind people with its bionic eye as part of a clinical trial in Melbourne. Researchers said they were “very pleased” with the progress of all four patients who have had a “sen
- Acuvue Oasys with Transitions Light Intelligent Technology Named Among TIME’s ‘Best Inventions of 2018’https://modernod.com/news/acuvue-oasys-with-transitions-light-intelligent-technology-named-among-times-best-inventions-of-2018/2479661/TIME has selected Acuvue Oasys with Transitions Light Intelligent Technology as one of the ‘Best Inventions of 2018,’ in its annual round-up spotlighting groundbreaking innovations worldwide. The development of Acuvue Oasys with Transitions has created and defined an entirely new cate