- Tags: FDA approval
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
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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.
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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.
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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.
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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.
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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.
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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.
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FDA clears Rayner's Sophi phacemulsification system
First battery-powered, wireless phaco system features triple pump fluidics for more control of anterior chamber stability during cataract surgery.
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FDA approves Gland Pharma's OTC Extra Strength Pataday generic
Olopatadine HCl ophthalmic solution 0.7% is indicated to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair, and dander for 24 hours.
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FDA clears first EDOF contact lens for presbyopia
U.S. approval is first for a daily disposable, extended-depth-of-field lens requiring no patient cognitive adaptation period for presbyopia correction.
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FDA approves Formycon and Bioeq's Lucentis biosimilar
Nufymco (ranibizumab-leyk) marks the companies’ second ranibizumab biosimilar cleared in the U.S. to treat five retinal indications.
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FDA approves Alembic Pharma's loteprednol etabonate and tobramycin ophthalmic suspension
Generic of Bausch + Lomb’s ZYLET for steroid-responsive inflammatory ocular conditions qualifies for 6 months of market exclusivity once commercially launched.
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Amneal receives FDA approval for Restasis generic
Generic version of Allergan’s cyclosporine ophthalmic emulsion 0.05% eye drop for dry eye is the second to receive U.S. regulatory clearance.
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FDA approves new EYLEA HD indication, expanded dosing intervals
Intravitreally-administered 2 mg aflibercept therapeutic is now cleared for macular edema following retinal vein occlusion.
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FDA clears Topcon's OMNIA auto kerato-refracto tonometer
Now commercially available, the fully automated ophthalmic device offers refraction, keratometry, tonometry, and pachymetry.
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