- Tags: FDA 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
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.
Products
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.
Products
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.
Products
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.
Products
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.
Products
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.
Products
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.
Products
FDA clears Topcon's OMNIA auto kerato-refracto tonometer
Now commercially available, the fully automated ophthalmic device offers refraction, keratometry, tonometry, and pachymetry.
Products
FDA approves Glaukos' Epioxa corneal CXL therapy
Second-generation CXL therapy is now the first FDA-approved topical drug therapy that does not require removal of the corneal epithelium.
Products
FDA approves BVI Medical's FINEVISION HP trifocal IOL
Third-generation premium lens features a unique diffractive design while utilizing the proprietary CoPODize technology for minimized visual disturbances.
Products
FDA approves Celltrion's Eylea bisoimilar
EYDENZELT (aflibercept-bvoa) is indicated for patients with wet AMD, macular edema following RVO, DME, and DR.
Products
FDA approves Rayner's RayOne EMV Toric IOL
Newest lens offers high-quality visual outcomes for patients with astigmatism, including monofocal levels of contrast sensitivity, and low dysphotopsia.
Products
FDA approves FDC Limited's pilocarpine HCl ophthalmic solution
ANDA approval for generic eye drop extends to three concentrations: 1%, 2%, and 4%.
Products
FDA approves Amneal's bimatoprost 0.01% generic
Generic version of Allergan’s LUMIGAN is indicated for reducing elevated IOP in glaucoma and ocular hypertensive patients.
Products
FDA reportedly clears Moria Surgical's corneal storage solution
XTRA4 is designed to preserve refrigerated human donor corneas for up to 14 days—reducing risk for graft detachments and improving availability for corneal transplant patients.
Products
FDA approves LENZ Therapeutics' VIZZ for presbyopia
LNZ100, now VIZZ, is the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia in adults.
Products