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Optical/Ophthalmic

Medicine-saving Nanodropper makes history in Minnesota Cup win

September 21, 2021 By Jim Hammerand

Nanodropper

The Minnesota Cup has awarded its grand prize for innovative entrepreneurs to a student-led startup for the first time. Medical device developer Nanodropper took home top honors from the awards ceremony, held Monday at the University of Minnesota. “We have created an eyedrop bottle adaptor that will save billions in medication waste, one drop at […]

Filed Under: Funding Roundup, Optical/Ophthalmic Tagged With: Nanodropper

FDA approves first Lucentis injection biosimilar for treating eye diseases

September 20, 2021 By Sean Whooley

Samsung Bioepis

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) is the first biosimilar to Lucentis (ranibizumab injection). It treats several eye diseases and conditions, including neovascular (wet) age-related macular degeneration (nAMD). The treatment involves an intravitreal injection (delivered into […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Optical/Ophthalmic, Pharmaceuticals Tagged With: FDA, Samsung Bioepis

Glaukos announces licensing deal with Attillaps for pharmaceutical compounds

September 20, 2021 By Sean Whooley

Glaukos Attillaps

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 […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Optical/Ophthalmic, Pharmaceuticals Tagged With: Attillaps, Glaukos

Ivantis to pay $60M in patent litigation settlement with Glaukos

September 15, 2021 By Sean Whooley

Glaukos logo

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. […]

Filed Under: Business/Financial News, Drug-Device Combinations, Food & Drug Administration (FDA), Implants, Legal News, Optical/Ophthalmic, Stents Tagged With: Glaukos, Ivantis

Glaukos submits supplemental PMA application for iStent Infinite

September 3, 2021 By Sean Whooley

Glaukos logo

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. […]

Filed Under: Auto-injectors, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Implants, Optical/Ophthalmic, Regulatory/Compliance, Stents Tagged With: FDA, Glaukos

Visus Therapeutics adds to ophthalmic drug portfolio, licenses delivery tech

August 19, 2021 By Sean Whooley

Visus Therapeutics

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 […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Optical/Ophthalmic, Pharmaceuticals Tagged With: Visus Therapeutics

NovaBay Pharmaceuticals to distribute Okra Limited’s dry eye products

August 19, 2021 By Sean Whooley

NovaBay Pharmaceuticals

NovaBay Pharmaceuticals (NYSE:NBY) announced today that it agreed with Okra Limited to distribute its Zocular dry eye products. The agreement allows NovaBay to distribute Zocular dry eye products alongside Avenova in its physician-dispensed sales channel. Zocular products are formulated with patented Zokrex technology, which contains activated natural okra polysaccharide complexes designed to gently and effectively […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Optical/Ophthalmic Tagged With: novabay

Ocular Therapeutix misses on earnings, tops Q2 revenue estimates

August 10, 2021 By Sean Whooley

Ocular Therapeutix logo

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. The Bedford, Mass.-based ophthalmology drug delivery company posted losses of […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, MassDevice Earnings Roundup, Optical/Ophthalmic, Pharmaceuticals Tagged With: Ocular Therapeutix

Eyevensys raises $12M for its gene therapy ocular drug delivery platform

August 4, 2021 By Sean Whooley

Eyevensys

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) […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Funding Roundup, Optical/Ophthalmic Tagged With: Eyevensys

FDA grants iStar Medical IDE for glaucoma implant pivotal trial

July 15, 2021 By Sean Whooley

MINIject iSTAR

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, enrolling over 350 patients with primary open-angle glaucoma. MINIject combines the porous structure of iSTAR’s proprietary STAR material […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Implants, Optical/Ophthalmic Tagged With: FDA, iSTAR Medical

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