- Tags: FDA approval
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FDA approves Xbrane Biopharma's Lucentis biosimilar
Lucamzi (ranibizumab-blrz) is expected to launch in 2027 as the latest intravitreal injection with its reference biologic’s same five retinal indications.
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Alcon's Brytly Redness Reliever Drops receive FDA approval
Company reports effects lasting up to 12 hours for the first OTC drop in the U.S. with apraclonidine—50% longer than Lumif
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FDA approves RYZUMVI for presbyopia
Phentolamine ophthalmic solution 0.75% now has two indications in the U.S.; commercial launch timeframe is unknown as Viatris seeks a partner.
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FDA approves Genentech's Enspryng as first at-home TED injection
Subcutaneous version of satralizumab-mwge can be administered by a patient or caregiver following training from an HCP.
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FDA approves Rayner's RayOne Galaxy spiral IOL
Touted as the world’s first-ever spiralized IOL, the AI-developed platform is now commercially available across the United States.
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FDA expands TearCare System indication for MG function improvement
Label update makes the 510(k)-cleared device the first and only for this indication; includes an optional debridement.
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FDA clears ZEISS Clinic 360 ophthalmic analytics dashboard
All-in-one, cloud / browser-based software solution integrates into ophthalmic workflows with flexible and scalable data management for patient care.
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FDA clears Sight Sciences' OMNI Ultra Surgical System
Latest iteration of the hand-held, single-use MIGS device is the first cleared for circumferential canaloplasty in a single pass.
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FDA approves Outlook's LYTENAVA for wet AMD
The VEGF inhibitor is now the first and only on-label ophthalmic formulation of bevacizumab for wet AMD treatment.
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FDA clears Viridian's veligrotug for TED as Lumvoa
Lumvoa (veligrotug-vvze) will launch immediately as the second FDA-approved TED treatment—and the first with labeling for both active and chronic TED.
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FDA clears Euclid's Be Free Day multifocal toric contact lens
New SiHy lens offers myopia / astigmatism management with a patented dual-action, multi-step optical design technology for presbyopia correction.
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FDA clears Heidelberg's new SPECTRALIS software release
Platform’s OCTA Module with SHIFT technology adds image scanning speeds up to 250 kHz—among other advancements for multimodal retinal imaging.
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FDA approves Lupin's Lucentis biosimilar injection
Ranluspec (ranibizumab-hkdz) marks the third ranibizumab biosimilar cleared in the U.S. to treat five retinal indications.
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FDA approves extended Vabysmo label for macular edema following RVO
Updated labeling enables IVT treatment beyond 6 months, intended to enable more flexible and tailored treatment plans.
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FDA clears Bausch + Lomb's Bi-Blade+ vitrectomy cutter and fluidics technology
Dual-port vitrectomy cutter increases cutting speed from 15K to 25K per minute, while Adaptive Fluidics update expands capabilities of the Stellaris Elite system
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FDA clears the OCULUS Pentacam Cornea OCT
Diagnostic device combines OCT and Schleimpflug imaging to provide advanced cornea visualization via a single, 1-second measurement process.
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FDA approves expanded EYLEA HD dosing intervals
VEGF inhibitor cleared for every 20 weeks among wet AMD and DME patients; clearance based on 96-week data from the PHOTON and PULSAR pivotal trials.
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FDA approves J&J's TECNIS PureSee IOL for cataract patients
Approval is the first extended-depth-of-focus lens with no warning on loss of contrast sensitivity; availability to follow later this year.
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FDA tentatively approves Gland Pharma's brimonidine tartrate 0.025% generic
Final approval and U.S. market launch are still pending for the generic version of Bausch + Lomb’s over-the-counter LUMIFY redness reliever drops.
Products