WHAT'S NEW IN CORNEA
Amneal Pharmaceuticals announced the approval and launch of complex generic fluorometholone ophthalmic suspension, USP, 0.1%. The product received 180-day competitive generic therapy exclusivity from the FDA. FML suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment.
Azura Ophthalmics presented positive 6-month data at ASCRS evaluating AZR-MD-001 for meibomian gland dysfunction (MGD). AZR-MD-001 met the co-primary endpoints at 3 months. Longer-term data showed that treatment for up to 6 months further improved signs and reduced symptoms of MGD.
Bausch + Lomb announced the US commercial launch of MIEBO (perfluorohexyloctane ophthalmic solution) for the treatment of the signs and symptoms of dry eye disease (DED). MIEBO is an eyedrop designed to address the signs and symptoms of DED by reducing tear evaporation at the ocular surface.
BRILL S.L. announced its entry into the US ophthalmology market with the Corneal Esthesiometer Brill. The tool will allow ophthalmologists and optometrists to detect early stages of corneal sensation loss, allowing them to prescribe more specific treatments and monitor their effectiveness through a non-invasive diagnostic tool, the company says.
CorNeat Vision introduced the CorNeat EverPatch synthetic tissue substitute for ocular surface surgeries. Its structure enables seamless integration with surrounding tissue without triggering a chronic foreign body response, and its non-degradability permanently reinforces the ocular surface. The CorNeat EverPatch provides a reinforcing tissue over glaucoma drainage devices.
The FDA cleared Heidelberg Engineering’s ANTERION platform that combines biometry, IOL power calculation with corneal topography and tomography, anterior chamber metrics, and high-resolution imaging. Eye tracking and composite imaging technologies deliver sharp image quality, allowing physicians to perform anterior segment exams.
Lupin Limited received FDA approval for its abbreviated NDA for loteprednol etabonate ophthalmic suspension, 0.2%, to market a generic equivalent to the reference listed drug Alrex Ophthalmic Suspension, 0.2% (Bausch + Lomb). Loteprednol is for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.
NovaBay Pharmaceuticals announced the US commercial launch of Avenova Allograft through its physician-dispensed channel. It is the first optic allograft manufactured using BioStem Technologies’ proprietary process and is intended for use as a protective covering during the repair of ocular surfaces.
The FDA approved ZEISS Medical Technology’s VISUMAX 800 with SMILE pro software from ZEISS for surgically treating nearsightedness, with or without astigmatism. The femtosecond laser enables fast treatment, creating the lenticule in less than 10 seconds due to a pulse repetition rate of 2 MHz.
IN THE NEWS
The FDA approved Bausch + Lomb’s LUMIFY Preservative Free redness reliever eyedrops. LUMIFY is the first OTC preservative-free eyedrop with low-dose OTC brimonidine tartrate for the treatment of ocular redness due to minor eye irritations.
Regeneron responded to a complaint filed by the U.S. Department of Justice (DOJ) that alleges it misreported the ASP for Eylea by not taking into account credit card service fees incurred by its distributors and reimbursed by Regeneron. Regeneron stated it “believes the complaint is meritless and illustrates a fundamental misunderstanding by the DOJ of drug price reporting standards.”
Eric Donnenfeld, MD, presented results from the Phase 3 OPTIMIZE-1 trial of OCS-01 (Oculis Holding AG) for the treatment of inflammation/pain following cataract surgery at ASCRS. Results showed 57.2% of patients treated with OCS-01 were inflammation free at Day 15 and 75.5% had absence of ocular pain at Day 4.
iHealthScreen Inc. received a US patent for its iPredict glaucoma detection model that provides a fully automated detection report that can be implemented in primary care settings for screening/detection of early-stage glaucoma.
AEYE Health received FDA clearance for AEYE Diagnostic Screening technology (AEYE-DS), a fully autonomous artificial intelligence that diagnoses referable diabetic retinopathy (DR) from retinal images obtained by a handheld camera.
