- Tags: FDA approval
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.
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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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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.
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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.
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FDA approves Celltrion's Eylea bisoimilar
EYDENZELT (aflibercept-bvoa) is indicated for patients with wet AMD, macular edema following RVO, DME, and DR.
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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.
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FDA approves FDC Limited's pilocarpine HCl ophthalmic solution
ANDA approval for generic eye drop extends to three concentrations: 1%, 2%, and 4%.
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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.
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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.
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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.
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FDA approves Amneal's prednisolone acetate ophthalmic suspension
Referencing Allergan's Pred Forte, this 1% concentrated drop is expected to hit the U.S. market by Q3 2025.
Products
FDA approves Alcon's TRYPTYR (acoltremon ophthalmic solution) 0.003% for DED
The prescription-based eye drop is the first that stimulates corneal nerves to directly address tear deficiency; company plans for a Q3 2025 U.S. launch.
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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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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.
Products
FDA clears BVI's laser endoscopic ophthalmic system
Set to debut at AAO later this year, Leos will launch as the only next-gen laser system that lowers IOP by addressing aqueous humor production in a minimally invasive ab interno procedure.
Products
FDA grants ANDA approval to olopatadine hydrochloride for ocular allergy relief
Generic of Alcon’s Pataday Once Daily Relief is intended for use as an antihistamine to treat itchy eyes.
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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.
Products