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HORA-PDE6b Gets FDA Rare Pediatric Disease Status
eyeDNA Therapeutics, a newly created subsidiary of Coave Therapeutics, has announced that the U.S. Food and Drug Administration (FDA) has granted a Rare Pediatric Disease Designation (RPDD) for HORA-PDE6b, the company’s novel gene therapy designed to treat inherited retinal dystrophy…
FDA Approves SB-007 for Stargardt Disease
The FDA has cleared an Investigational New Drug (IND) application for SB-007, an adeno-associated viral (AAV) vector gene therapy targeting the root genetic cause of Stargardt disease, according to a press release from SpliceBio. Addressing Stargardt Disease Across All ABCA4…
Vabysmo Prefilled Syringe Approved in EU
The European Medicines Agency (EMA) has approved Roche’s Vabysmo (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for the treatment of wet age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). A Convenient Treatment…
Atsena Completes XLRS Gene Therapy Trial Dosing
Atsena Therapeutics has successfully completed dosing in Part A of the LIGHTHOUSE study, a Phase I/II clinical trial evaluating the subretinal delivery of ATSN-201 for the treatment of X-linked retinoschisis (XLRS). The study represents an important step forward in developing…
Top 12 Ophthalmic Drugs That Received FDA Approval
2024 Recap is here! Click to review:Top 8 FDA Approvals in Opthalmology In a series of groundbreaking developments, the FDA has approved a range of innovative drugs in 2023, heralding a new era in ophthalmic treatments. Here’s an in-depth look…
Tenpoint and Visus Merge to Advance Eye Care
Tenpoint Therapeutics Ltd. and Visus Therapeutics Inc. have officially merged, combining their respective ophthalmic therapeutic assets to form a unified entity focused on addressing ocular conditions associated with aging, including presbyopia, cataracts, and geographic atrophy. Key Therapeutics in the Combined…
VSY Biotechnology Appoints Dr. Christian Bach MD
VSY Biotechnology GmbH, a global leader in ophthalmic innovation and research, has announced the appointment of Dr. Christian Bach as the new Managing Director, effective November 1, 2024. Extensive Experience in Medical Devices Dr. Bach brings over 25 years of…
Researchers Find 101 Genetic Links to Cataracts
In the largest genetic study on cataracts to date, researchers from QIMR Berghofer Medical Research Institute have identified 101 genetic regions associated with an increased risk of developing cataracts. This groundbreaking study analyzed DNA from over 950,000 individuals, providing significant…
ESCRS 2024 Exclusive Insights: iNovation Day in Focus
The European Society of Cataract and Refractive Surgeons (ESCRS) is gearing up for an innovative event with its iNovation® Day in Barcelona, Spain, on Friday 6 September 2024 at the Fira Barcelona Gran Via. Scheduled to be held prior to…
Rayner Recalls RayOne Preloaded Hydrophilic IOLs I OBN
According to a notice published by the FDA on July 6, Rayner has issued a letter to recall its RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens. The reason behind this was that…