- Category: Products
- Tags: retina
Products
FDA approves Genentech's Susvimo for DR
First sustained-release delivery system of ranibizumab earns third indication, with injections needed just once every 9 months.
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Zeiss debuts new research data platform for integrated workflows
Company’s cloud-based solution uses AI technology to integrate accessible clinical and research data into clinicians’ daily routines.
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OcuSciences receives FDA clearance for retinal health assessment tool
The OcuMet Beacon, a confocal scanning ophthalmoscope, is indicated to provide a rapid, pain-free, and noninvasive imaging evaluation for earlier disease detection.
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FDA accepts Regeneron's EYLEA HD sBLA for priority review
Agency sets target action date of Aug. 19 to consider a new indication for macular edema following RVO and expanded monthly dosing.
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Settlement paves way for US commercialization of Eylea biosimilar
Biocon Biologic’s YESAFILI (aflibercept-jbvf) now expected to launch in H2 2026 after dismissal of Regeneron’s patent infringement lawsuits.
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FDA approves expanded label of ILUVIEN for chronic posterior uveitis
Updated label for sustained-release fluocinolone acetonide intravitreal implant now includes noninfectious uveitis affecting the posterior segment of the eye.
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FDA approves Neurotech's ENCELTO cell therapy for MacTel
Approval of revakinagene taroretcel-lwey is the first-ever for the treatment of this rare, neurodegenerative retinal disease.
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Optos launches next-gen UWF imaging system with SD-OCT
The MonacoPro increases macular pathology identification by 29.4% when combined with the integrated 200° single-shot optomap imaging.
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FDA approves updated label for IZERVAY to treat GA
Astellas’s avacincaptad pegol now has no limitation on its dosing duration, enabling longer-term administration for patients with GA secondary to AMD.Products
FDA approves Genentech's Susvimo for DME
The first sustained-release delivery system of ranibizumab secures its second indication for retinal disease, requiring as few as two injections per year.
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AI Optics receives FDA 510(k) clearance for handheld retinal imaging system
The Sentinel Camera is designed as a portable screening device enabling point-of-care retinal imaging and non-dilated imaging.
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Visible Genomics' AMD genetic tests target early disease detection
Comprehensive risk assessment uses patients' genetic status, ocular findings, demographics, and lifestyle characteristics to deliver a comprehensive and clinically actionable risk assessment
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FDA grants 510(k) clearance to Norlase's LYNX pattern-scanning LIO
Company also announces the immediate commercial launch of its laser indirect ophthalmoscope—the world’s first and only.
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iCare to release updated version of MAIA microperimeter
Upgraded device includes customized, patient-specific test patterns and 60° field of view capabilities to detect and manage macula-based diseases.Products
FDA accepts revised sNDA of IZERVAY for GA
Company is requesting inclusion of 24-month data to extend approved dosage for an additional 12 months for both every-month and every-other-month dosing.
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FDA grants authorization to LumiThera's Valeda system for dry AMD
Approval makes the photobiomodulation treatment the first device of its kind to treat vision loss among dry AMD patients.
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Zeiss showcases expanded ophthalmic portfolio of digital tools
Company introduces new AI-based software solutions and highlights technologies from its Cataract and Retina Workflows as well as two new microscopes.
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Visionix introduces VX 610 automated fundus camera
Non-mydriatic fundus camera features cross-polarized light technology, eliminating the need for pupil dilation while ensuring image clarity.
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FDA approves Sandoz's EYLEA biosimilar for wet AMD
Approval of Enzeevu (aflibercept-abzv) is expected to be key in growing the company’s U.S. biosimilar-based ophthalmic portfolio.
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