The FDA announced today that it approved Samsung Bioepis’ Byooviz injection, making it the first approved biosimilar to Lucentis for treating eye diseases. Byooviz (ranibizumab-nuna), the first biosimilar to Lucentis (ranibizumab injection), treats several eye diseases and conditions, including neovascular (wet) age-related macular degeneration (nAMD). The treatment is administered by intravitreal injection (delivered into the […]
Optical/Ophthalmic
Glaukos announces licensing deal with Attillaps for pharmaceutical compounds
Glaukos (NYSE:GKOS) announced today that it entered into a licensing agreement with Attillaps for its library of pharmaceutical compounds. San Clemente, California-based Glaukos was granted a global exclusive license to research, develop, manufacture and commercialize Attillaps’ proprietary library of investigational pharmaceutical compounds that target the eradication of Demodex mites — the root cause of Demodex blepharitis […]
Ivantis to pay $60M in patent litigation settlement with Glaukos
Glaukos (NYSE:GKOS) announced today that it entered into a settlement with Ivantis to terminate a three-year-old patent infringement lawsuit. San Clemente, California-based Glaukos’ patent infringement lawsuit, initiated on April 14, 2018, in the U.S. District Court for the Central District of California, Southern Division, concerned Ivantis’ Hydrus Microstent for reducing eye pressure in glaucoma patients. Get the full […]
Glaukos submits supplemental PMA application for iStent Infinite
Glaukos (NYSE:GKOS) announced today that it submitted a supplemental premarket approval application to the FDA for its iStent Infinite system. San Clemente, California–based Glaukos designed the iStent Infinite trabecular micro-bypass system for use in a standalone procedure to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma uncontrolled by prior surgery or medical therapy. Get […]
Visus Therapeutics adds to ophthalmic drug portfolio, licenses delivery tech
Visus Therapeutics announced today that it entered into worldwide licensing agreements with Cella Therapeutics and DelSiTech. The exclusive worldwide licensing agreement with Cella covers the development of investigational ophthalmic therapies for treating glaucoma and age-related macular degeneration (AMD). The additional worldwide exclusive licensing agreement with DelSiTech will lead to the development of novel drug delivery […]
Staar Surgical rises on Street-beating Q2, raised guidance
Staar Surgical (NSDQ:STAA) shares ticked up today on second-quarter results that topped the consensus forecast. The Lake Forest, Calif.-based implantable lens maker posted profits of $8.6 million, or 17¢ per share, on sales of $62.4 million for the three months ended July 2, 2021, for a massive bottom-line from over $1 million in the red […]
Ocular Therapeutix misses on earnings, tops Q2 revenue estimates
Ocular Therapeutix (NSDQ:OCUL) shares ticked up this morning on second-quarter results that topped revenue forecasts. OCUL shares were up nearly 2% at $10.94 apiece in morning trading today. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was down slightly. Get the full story at our sister site, Drug Delivery Business […]
Eyevensys raises $12M for its gene therapy ocular drug delivery platform
Eyevensys, a developer of gene therapies for ophthalmic diseases, announced today that it raised $12 million in a Series B plus funding round. The funding, led by Korea Investment Partners, also includes existing investors who will join the round and support the accelerated development of Eyevensys’ EYS809 program for treating wet age-related macular degeneration (AMD) […]
The 18 most innovative medical devices of 2021
The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards. The foundation nominates devices, biotechnology and pharmaceutical products for its annual Prix Galien awards to highlight products designed to improve the human condition. “The Awards Committee is excited to introduce the nominees for the 2021 […]
FDA grants iStar Medical IDE for glaucoma implant pivotal trial
iSTAR Medical announced today that the FDA granted investigational device exemption to start a pivotal trial with its MINIject implant. Wavre, Belgium–based iStar’s MINIject minimally invasive implant for glaucoma surgery will be investigated in the STAR-V study, which will enroll over 350 patients with primary open-angle glaucoma. Get the full story at our sister site, Drug […]
FDA accepts biologics license application for Genentech’s drug-eluting eye implant
Genentech announced that the FDA accepted its Biologics License Application (BLA) for its Port Delivery System (PDS) with ranibizumab. The PDS is a permanent, refillable eye implant standing at the approximate size of a grain of rice. It offers continuous delivery of a customized formulation of ranibizumab over a period of months to reduce the treatment […]
