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Home » Topics » Disease categories and therapies » Ophthalmic

Ophthalmic
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Laptop displaying FDA logo

FDA moves to down-classify cyclodestruction in glaucoma

May 20, 2024
By Mark McCarty
Ultrasound cyclodestruction may not be the darling of American ophthalmologists and their patients dealing with glaucoma, but that may soon change thanks to a recent move by the U.S. FDA. The agency has down-classified these devices from class III to class II in a move that may prompt competition for current device-based methods of treating glaucoma, including widely used laser-based treatments.
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Arcscan

China approves Arcscan’s ultrasound imaging device for myopia

May 17, 2024
By Marian (YoonJee) Chu
Denver-based Arcscan Inc. gained Chinese approval of its computer-controlled, ultra-high frequency ultrasound diagnostic imaging solution for myopia called Insight 100, expanding its reach beyond the U.S. and Europe.
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Business people with hands atop a digital globe

J&J’s Duato says company to continue M&A surge

April 17, 2024
By Holland Johnson
As Johnson & Johnson's (J&J) first-quarter revenue missed Wall Street estimates for medical devices on April 16, CEO Joaquin Duato noted that the company will continue to look for major M&A plays to boost long-term growth in the wake of its recently reported $13.1 billion buy of Shockwave Medical Inc.
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Illustration of the inside of an eye with macular degeneration

FDA advisory panel sees benefit in ocular negative pressure therapy

April 1, 2024
By Mark McCarty
The notion of using vacuum pressure on the anterior portion of the human eye as a treatment for open-angle glaucoma might be a clinical novelty, but Balance Ophthalmics Inc. is poised to change that. The company recently won a favorable outcome at a U.S. FDA advisory panel for its Fsyx negative pressure pump for ocular use, although the company is likely to have to drum up a large body of data in post-approval studies, assuming the FDA gives the Fsyx the nod.
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Architectural pillars

US court sees fines levied on Precision Lens as unconstitutional

Feb. 20, 2024
By Mark McCarty
The U.S. Department of Justice (DOJ) announced in May 2023 that it had obtained a judgment of more than $487 million against the parent company of Precision Lens for alleged violations of the False Claims Act (FCA), but the amount of that decision has been overturned. In a Feb. 8 decision, the U.S. District Court for the District of Minnesota decreed that the judgment be reduced to less than $217 million, an outcome which suggests that some of the more excessive fines levied against health care companies will be viewed with more skepticism upon appeal.
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Spyglass intraocular drug delivery
Patents

Spyglass strengthens IP for intraocular drug delivery platform

Feb. 7, 2024
By Simon Kerton
Spyglass Ophthalmics Inc. is seeking patent protection for intraocular drug delivery devices and methods of delivering therapeutic agents to the eye. The methods include implanting an intraocular implant into the eye and adjacent to a fluid-permeable membrane of the patient’s eye.
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Discovery of known and previously undescribed loci from the discovery mega-analysis of African ancestry individuals
Ophthalmic

African ancestry GWAS yields glaucoma risk loci

Jan. 26, 2024
Primary open-angle glaucoma is the leading cause of blindness globally. Individuals of African ancestry have a disproportionately high risk of developing glaucoma, but genetic risk factors have been studied mainly in populations of European ancestry.
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VIisumax 800 with Smile-pro software

Carl Zeiss Meditec receives FDA approval for latest femtosecond laser

Jan. 24, 2024
By Shani Alexander
Carl Zeiss Meditec AG recently received U.S. FDA clearance for the latest generation of its femtosecond laser, the Visumax 800, with its Smile pro software, for surgically treating nearsightedness, with or without astigmatism.
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Polyactiva implant next to coin

Polyactiva’s ocular implant shows sustained drug delivery for glaucoma

Nov. 21, 2023
By Tamra Sami
Ophthalmology company Polyactiva Pty Ltd.’s biodegradable ocular implant provides six months of sustained drug delivery for patients with glaucoma and is the first biodegradable ocular implant that has the potential to be used safely for repeat dosing, Polyactiva CEO Vanessa Waddell told BioWorld.
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Polyactiva implant next to coin

Polyactiva’s ocular implant shows sustained drug delivery for glaucoma

Nov. 16, 2023
By Tamra Sami
Ophthalmology company Polyactiva Pty Ltd.’s biodegradable ocular implant provides six months of sustained drug delivery for patients with glaucoma and is the first biodegradable ocular implant that has the potential to be used safely for repeat dosing, Polyactiva CEO Vanessa Waddell told BioWorld.
Read More
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