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Optical/Ophthalmic

NovaBay prices $15M private placement

November 1, 2021 By Sean Whooley

NovaBay Pharmaceuticals

NovaBay Pharmaceuticals (NYSE:NBY) announced today that it entered into a securities purchase agreement, with proceeds of approximately $15 million. Emeryville, California-based NovaBay’s agreement with certain institutional investors occurred in connection with a private placement of 15,000 shares of a newly created Series B non-voting convertible preferred stock. The Series B preferred stock comes in at […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Funding Roundup, Optical/Ophthalmic, Pharmaceuticals, Wound Care Tagged With: Dermadoctor, novabay

FDA approves first nasally administered pharmaceutical treatment for dry eye

October 25, 2021 By Sean Whooley

Aptar Pharma Oyster Point CPS Tyrvaya

AptarGroup (NYSE:ATR) announced today that it received FDA approval for its nasal pump to deliver a pharmaceutical treatment for dry eye. Crystal Lake, Illinois–based Aptar said the patented Cartridge Pump System (CPS) is for the multidose delivery of preserved and non-preserved drug formulations. It has received approval as the device for delivering Oyster Point Pharma’s […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Optical/Ophthalmic, Pharmaceuticals, Regulatory/Compliance Tagged With: aptarpharma, FDA, oysterpointpharma

FDA approves Genentech’s Susvimo drug-eluting eye implant

October 22, 2021 By Sean Whooley

Genentech Susvimo Implant Image 1 For Media

Genentech announced today that it received FDA approval for its Susvimo injection for treating macular degeneration (AMD). South San Francisco-based Genentech, a member of the Roche Group, designed its Susvimo ranibizumab injection (100 mg/mL) for intravitreal use via ocular implant for treating people with wet, or neovascular, age-related macular degeneration (AMD) who have previously responded […]

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

Ocular Therapeutix dry eye treatment trial fails to meet primary endpoint

October 22, 2021 By Sean Whooley

Ocular Therapeutix logo

Ocular Therapeutix (NSDQ:OCUL) announced today that its Phase 2 clinical trial for treating dry eye disease (DED) did not meet its primary endpoint. Bedford, Massachusetts-based Ocular Therapeutix’s U.S.-based, randomized, double-masked, multi-center, vehicle-controlled Phase 2 clinical trial evaluated OTX-CSI (cyclosporine intracanalicular insert) for treating DED by measuring signs and symptoms of DED in 140 subjects treated […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Optical/Ophthalmic Tagged With: Ocular Therapeutix

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

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