Bayer’s higher dose aflibercept 8 mg with extended treatment intervals is set for approval in the European Union (EU) for neovascular age-related macular degeneration (nAMD) and diabetic macular oedema (DME).
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FDA updates warning for contaminated eyedrop products
The US Food and Drug Administration (FDA) has issued product warnings for an additional 27 over-the-counter eyedrop products due to the potential risk of eye infections that could result in partial vision loss or blindness.
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FDA clears higher dose Eylea; approvals sought in other markets
The US FDA has approved the use of high dose Eylea (aflibercept) for three macular conditions, equating to longer intravitreal injection intervals for patients.
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FDA approves Iveric Bio’s IZERVAY for geographic atrophy
The US Food and Drug Administration (FDA) has approved a second therapy for geographic atrophy (GA), with IZERVAY (avacincaptad pegol intravitreal solution) by Iveric Bio given clearance with its new complement C5 inhibitor.
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Eyerising Myopia Management Device granted TGA approval for home-use red-light therapy
Medtech company Eyerising International Pty Ltd has announced its myopia management device – based on repeated low-level red-light (RLRL) technology that can be used at home – has been approved by the Australian Therapeutic Goods Administration (TGA).
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FDA approves Apellis’ SYFOVRE for first geographic atrophy treatment
In a historic first, the US Food and Drug Administration (FDA) has approved SYFOVRE (pegcetacoplan injection), manufactured by global biopharmaceutical company Apellis Pharmaceuticals, for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
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Eye disease AI screening system TGA-approved
The Therapeutic Goods Administration (TGA) has approved a new AI software system that can screen for three major eye diseases in primary care settings.
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Low-dose atropine EIKANCE secures first myopia TGA approval
The Therapeutic Goods Administration (TGA) has approved EIKANCE 0.01%, Australia’s first low-dose atropine eye drop for myopia progression in children and young teenagers.
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Lucentis now TGA-approved for retinopathy of prematurity
The Therapeutic Goods Administration (TGA) has granted Lucentis (ranibizumab) an indication for retinopathy of prematurity (ROP), making it the first anti-VEGF therapy approval for the rare disease affecting premature infants in Australia.
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FDA approves first presbyopia eye drop
US regulators have approved the country’s first presbyopia eye drop that adopts pupil constriction to improve near and intermediate vision while maintaining some pupillary response to different lighting conditions.
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