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Opus Genetics Receives FDA RPD Designation for OPGx-LCA5
Research Triangle Park, N.C. – August 20, 2024 – Opus Genetics has announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation for its ocular gene therapy, OPGx-LCA5, which aims to treat patients with…
Sandoz Receives FDA Approval for ENZEEVU™
Sandoz has secured FDA approval for ENZEEVU™ (aflibercept-abzv), a biosimilar to EYLEA®, to treat retinal conditions like wet age-related macular degeneration (AMD) and diabetic retinopathy. This approval strengthens Sandoz’s U.S. biosimilar portfolio, offering a cost-effective alternative for managing retinal diseases.…
AMD Explained: Tips for Safeguarding Your Vision
The eyes are often called the windows to the soul, but what happens when those windows become cloudy and blurred? That’s the reality for millions suffering from age-related macular degeneration (AMD), which can rob you of your precious eyesight as…
European Commission Approves Roche’s Vabysmo for RVO
The European Commission has approved Roche’s Vabysmo® (faricimab) for the treatment of macular edema secondary to retinal vein occlusion (RVO), including both branch and central retinal vein occlusion (BRVO and CRVO). This approval is a significant milestone, making Vabysmo the…
LENSAR Receives EU Certification for ALLY®
First EU ALLY Commercial Installation Expected in August 2024 ORLANDO, Fla.—LENSAR, Inc. (Nasdaq: LNSR), a global medical technology company specializing in advanced laser solutions for cataract treatment, announced that the ALLY Adaptive Cataract Treatment System has achieved certification under the…
Exclusive: Key Events at ESCRS 2024
The 42nd of the European Society of Cataract and Refractive Surgeons (ESCRS) is poised to offer a dynamic array of events and initiatives in 2024, featuring a mix of educational programs, commemorative milestones, and new insights into key areas of…
ViaLase Laser Granted CE Mark Approval for Glaucoma
ViaLase has received CE Mark approval in the European Union for its ViaLase laser, designed to treat adult patients with primary open-angle glaucoma. The ViaLase laser employs the precision of a femtosecond laser combined with micron-level image guidance to perform…
FDA Notifies Ocugen to Begin Expanded Access Program RP
The FDA has authorized Ocugen, Inc. to launch an expanded access program (EAP) for patients aged 18 and older with retinitis pigmentosa (RP), providing early access to its promising gene therapy candidate, OCU400. The treatment has shown encouraging results in…
Bausch + Lomb’s TENEO Laser Achieves Strong LASIK Outcomes
Bausch + Lomb recently published the results of a pivotal clinical trial for its TENEO™ Excimer Laser in the Journal of Refractive Surgery. This study, which played a crucial role in securing U.S. FDA approval for the device in January…
Ocular Therapeutix Enrolls First Patient in Phase 3 Wet AMD Study
Ocular Therapeutix announced that the first patients have been enrolled in its Phase 3 SOL-R clinical trial. This study aims to assess the repeat dosing of AXPAXLI™ (axitinib intravitreal implant, also known as OTX-TKI) for treating wet age-related macular degeneration…