- Tags: FDA approval
Products
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.
Products
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.
Products
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.
Products
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.
Products
FDA clears Viridian's veligrotug for TED as Lumvoa
Lumvoa (veligrotug-vvze) will launch immediately as he second FDA-approved TED treatment—and the first with labeling for both active and chronic TED.
Products
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.
Products
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.
Products
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.
Products
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
Products
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.
Products
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.
Products
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.
Products
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
FDA approves expanded age indication for STAAR's EVO/EVO+ Visian ICLs
U.S. age indication now includes patients aged 21 to 60 years old, making nearly 8 million refractive patients eligible for implantable collamer lens implantation.
Products
FDA approves DifGen's fluorometholone 0.1% complex generic for ocular inflammation
Prescription-based corticosteroid suspension is the second generic of AbbVie’s FML 0.1% to receive regulatory approval.
Products
FDA approves Tenpoint's YUVEZZI as first dual-agent presbyopia drop
First and only combination drop of carbachol and brimonidine tartrate achieves miosis within 30 minutes and lasts up to 10 hours following once-daily dosing.
Products
FDA approves Glaukos' iDose TR for repeat treatment labeling
Travoprost intracameral implant can now be re-administered using a repeat treatment protocol—enabling greater flexibility in glaucoma patient management.
Products
FDA approves Alembic's difluprednate 0.05% generic
Generic version of Sandoz’s Durezol is indicated for postop pain and inflammation as well as endogenous anterior uveitis.
Products