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Implants

Ocular Therapeutix touts positive trial results of ophthalmic insert for dry eye disease

December 6, 2021 By Sean Whooley

Ocular Therapeutix logo

Ocular Therapeutix (NSDQ:OCUL) announced today that it reported positive results from a Phase 2 trial of its dry eye disease treatment. Bedford, Massachusetts-based Ocular Therapeutix’s U.S.-based Phase 2 clinical trial evaluated OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of dry eye disease. The randomized, double-masked, vehicle-controlled, multi-center trial evaluated two different formulations of […]

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

Ocular Therapeutix claims win as court invalidates drug delivery patent from Mati

November 9, 2021 By Sean Whooley

Ocular Therapeutix logo

Ocular Therapeutix (NSDQ:OCUL) announced today that an appeals court invalidated a drug delivery system patent held by Mati Therapeutics. The U.S. Court of Appeals for the Federal Circuit in Washington, D.C., invalidated the patent related to a drug delivery system containing dexamethasone, affirming the judgment made in June 2020 by the Patent Trial and Appeal […]

Filed Under: Auto-injectors, Business/Financial News, Drug-Device Combinations, Featured, Implants, Legal News, Optical/Ophthalmic, Pharmaceuticals, Regulatory/Compliance Tagged With: Ocular Therapeutix

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

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

Lyra Therapeutics appoints new CFO

September 13, 2021 By Sean Whooley

Lyra Therapeutics LYR-210

Lyra Therapeutics (NSDQ:LYRA) announced today that it appointed Jason Cavalier as its new chief financial officer, effective today. Cavalier succeeds the company’s current CFO, Don Elsey, who is retiring while he remains expected to serve in an advisory role to assist with the transition. Watertown, Massachusetts-based Lyra — which develops the XTreo platform designed to […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Implants, Otolaryngology Ear, Nose & Throat Tagged With: Lyra Therapeutics, Personnel, Personnel Moves

Lyra touts non-human trial of XTreo drug-eluting implant

September 10, 2021 By Sean Whooley

Lyra Therapeutics LYR-210

Lyra Therapeutics (NSDQ:LYRA) is touting preclinical data for its XTreo drug-eluting implant for dosing in local sinus tissues. Watertown, Massachusetts-based Lyra’s preclinical results were published — “Drug Release and Pharmacokinetic Evaluation of Novel Implantable Mometasone Furoate Matrices in Rabbit Maxillary Sinuses” — were published online in the peer-review journal, American Journal of Rhinology & Allergy. The […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Implants, Otolaryngology Ear, Nose & Throat Tagged With: Lyra Therapeutics

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

Abbott CMO Dr. Nick West touts latest iteration of drug-eluting stent

August 2, 2021 By Sean Whooley

Abbott Xience Skypoint

Abbott executive Dr. Nick West believes the company offers the “best-in-class” drug-eluting stent with its Xience platform. When Abbott (NYSE:ABT) CMO & divisional VP of global medical affairs for its vascular business Dr. Nick West looks back at his use of drug-eluting stents in the early 2000s, all he sees now is innovation. As a practicing interventional cardiologist, West […]

Filed Under: Auto-injectors, Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Implants, Pharmaceuticals, Regulatory/Compliance, Vascular Tagged With: abbott, drug-eluting balloons, drug-eluting stents, FDA

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

Nanoform, Celanese partner to develop nanoparticle-enabled drug delivery

May 25, 2021 By Sean Whooley

Nanoform Celanese-logo

Nanoform announced today that it partnered with Celanese to explore the use of their technologies in nanoparticle-enabled drug delivery. Helsinki-based Nanoform said the goal of the collaboration is to assess the combination of its nanoparticle platform technologies with Celanese’s VitalDose EVA copolymer delivery technology for drug-eluting implants, according to a news release. Both companies intend […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Implants, Nanoparticles, Research & Development Tagged With: Celanese, Nanoform

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