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Home » Topics » Disease categories and therapies » Ophthalmic

Ophthalmic
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U.S. FDA headquarters

FDA posts draft guidance for LASIK labeling 14 years after advisory hearing

July 29, 2022
By Mark McCarty
The FDA’s ability, or lack thereof, to churn out guidances is not always the stuff of industrial outrage, but manufacturers of laser-assisted in situ keratomileusis (LASIK) systems might find the timing of a new draft guidance on the procedure somewhat odd. The draft guidance arrives nearly a decade and a half after an April 2008 advisory hearing.
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Miniject device with inset showing microscopic structure

Abbvie, Istar team up to advance Miniject for glaucoma patients

July 26, 2022
By Meg Bryant
Abbvie Inc. and Istar Medical SA inked a deal to develop and commercialize Istar’s Miniject device to treat patients with primary open-angle glaucoma. The minimally invasive glaucoma surgical (MIGS) device won CE mark approval in November and has been available in some European countries since early 2022.
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IC-8 Apthera IOL box

Acufocus secures FDA approval for Apthera lens

July 26, 2022
By Annette Boyle
The U.S. FDA gave the greenlight to Acufocus Inc. for its IC-8 Apthera intraocular lens (IOL) for the treatment of cataracts. Like most other IOLs implanted as part of cataract surgery, the small aperture Apthera provides excellent distance vision. It distinguishes itself by also providing clear intermediate and near vision, essentially eliminating the blurring of close objects or words common as people age and develop presbyopia.
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Forsight Robotics raises $55M series A to advance ophthalmic surgery platform

July 22, 2022
By Meg Bryant
Forsight Robotics Ltd. amassed up to $55 million in series A financing led by Adani Group, with participation by existing investors Eclipse Ventures and Mithril Capital. The new funds will be used to further development of Forsight’s Oryom system, a surgical platform for fully robotic cataract surgery.
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Precise Bio - bio-fabricated cornea

Carl Zeiss strikes commercial deal with Precise Bio to develop ophthalmology pipeline

July 18, 2022
By Catherine Longworth
Ophthalmic and microsurgery device maker Carl Zeiss Meditec AG is investing in regenerative medicine startup Precise Bio Ltd. to jointly develop 4D bio-fabricated corneal transplants for diseases that require endothelial keratoplasty and natural lenticule transplants. Under the terms of the agreement, Carl Zeiss Meditec will lead a series B financing round in Precise Bio and fund development of two cornea transplant products.
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Close-up of elderly eye

Aldeyra era nigh as last RASP hasp fastened with crossover study in DED

July 12, 2022
By Randy Osborne
Aldeyra Therapeutics Inc. CEO Todd Brady said that, with new data from a crossover trial with reproxalap in dry eye disease (DED), the question of “approvability has been put to bed,” and the company plans a pre-NDA meeting with U.S. FDA in the third quarter of this year.
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Smart Glasses

Envision unveils AI-powered glasses for the blind, visually impaired

July 1, 2022
By Bernard Banga
Envision Technologies BV’s latest artificial intelligence (AI)-powered smart glasses for the blind and visually impaired are designed to help with reading, scanning faces and navigating everyday tasks. This visual assistant was introduced at California State University Northridge (CSUN) 2022 Assistive Technology Conference. Envision has updated its AI-based platform and ecosystem with improved optical character recognition (OCR) and better text recognition with contextual intelligence.
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Close-up of eye with digital focus

Meduni Vienna develops eye scanner for detecting early-stage neurodegenerative conditions

April 11, 2022
By Bernard Banga
Meduni Vienna, the Medical University of Vienna, Austria, is working on a novel eye scanner combining the structural and functional sensitivity of optical coherence tomography (OCT) with the chemical specificity of Raman spectroscopy, to acquire data from the living human eye.
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Evo Visian ICL illustration over eye

Future comes into focus for Staar Surgical with FDA approval

March 29, 2022
By Annette Boyle
After more than 10 years on the market in Europe, Staar Surgical Co. can finally see a brighter future for its newest lenses in the U.S. This week, the company received FDA premarket supplement approval of its Evo/Evo+ Visian implantable lens for the correction of myopia and myopia with astigmatism in patients aged 21 to 45. Made of a proprietary poly(2-hydroxyethyl methacrylate)-based collagen co-polymer the company calls Collamer, the lens is inserted behind the iris in a quick procedure and can be removed, if needed. Unlike laser-assisted in situ keratomileusis (LASIK), the Evo procedure does not remove corneal tissue.
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Inserting contact lens into eye

New smart contact lens may diagnose, treat diabetes more comfortably

March 17, 2022
By Gina Lee
A smart contacts lens that detects diabetes and treats diabetic retinopathy could provide patients with a more comfortable alternative to insulin shots and monitoring blood glucose levels. The product was developed by a research team at the Pohang University of Science & Technology (POSTECH) that includes Sei Kwang Hahn, the CEO of Seoul, South Korea-based Phi Biomed Co. Ltd.
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