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1 week ago | 
optometrytimes.com | Sydney M Crago |Modern Retina |Emily Kaiser Maharjan
The FDA has granted 510(k) clearance to BVI Medical for its glaucoma surgical system, called Leos (Laser Endoscopy Ophthalmic System). Leos is designed to introduce a novel, intuitive Laser ECP procedure that can integrate seamlessly into the surgical workflow. Notably this is the only laser system that lowers intraocular pressure by addressing aqueous humor production in a minimally invasive ab interno procedure.
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1 week ago | 
optometrytimes.com | Sydney M Crago |Modern Retina
Oculis Holdings has completed enrollment in both Phase 3 DIAMOND-1 (NCT05066997) and DIAMOND-2 (NCT06172257) trials. These trials are investigating the company’s OCS-01 eye drops for the treatment of diabetic macular degeneration (DME) and are designed as pivotal registration studies to support global marketing applications including NDA submission and approval by the US Food and Drug Administration (FDA).
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1 month ago | 
optometrytimes.com | Sydney M Crago |Modern Retina
DCDR-Life under its collaboration and licensing agreement with Boehringer Ingelheim has completed its fifth milestone and is enrolling patients in a Phase 2 study to advance the candidate BI 771716, a novel therapeutic candidate for the treatment of geographic atrophy (GA).1This follows successful Phase 1 results, which demonstrated a favorable safety profile for BI 771716 across both single and multiple intravitreal doses.
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1 month ago | 
optometrytimes.com | Sydney M Crago |Modern Retina
Ocugen, Inc. completed dosing ahead of schedule in the Phase 2 portion of the Phase 1/2 ArMaDa clinical trial for OCU410. This candidate is a novel multifunctional modifier gene therapy candidate in development for the treatment of geographic atrophy (GA). OCU410 targets multiple pathways associated with GA.
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2 months ago | 
optometrytimes.com | John Berdahl |Sydney M Crago |Modern Retina |Jordana Joy
February 21, 2025By John Berdahl, MD, overviews the new FYXS Ocular Pressure Adjusting Pump and HERCULES trial at the Glaucoma 360 meeting. John Berdahl, MD, practicing in Sioux Falls, South Dakota discussed the FYXS Ocular Pressure Adjusting Pump during the recent Glaucoma 360 meeting. This is the first non-surgical, non-drug treatment for glaucoma approved by the FDA in June 2024. The pump consists of 2 ocular chambers that attach to a negative pressure pump.
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2 months ago | 
optometrytimes.com | Shan C. Lin |Sydney M Crago |Modern Retina |Jordana Joy
Shan Lin, MD, is the co-research director at the Glaucoma Center of San Francisco. At the Glaucoma 360 meeting, he discussed the new generation of minimally invasive glaucoma surgeries (MIGS). These include trabecular procedures like the CyPass which removes part of the trabecular meshwork, suprachoroidal stents like the iStent, and scleral-based procedures like Xen. There are also new minimally invasive filtration surgeries like the Preserflo MicroShunt.
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Jan 20, 2025 | 
optometrytimes.com | Sydney M Crago |Modern Retina
Ocugen, Inc. announced the positive 2-year safety and efficacy update for the Phase 1/2 OCU400 clinical trial for the treatment of early to advanced retinitis pigmentosa (RP) in pediatric and adult populations. According to the company, OCU400 demonstrated meaningful improvement of 2-line gain (10 letters on ETDRS chart) in low-luminance visual acuity (LLVA) in treated eyes when compared to untreated fellow eyes.
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Jan 13, 2025 | 
optometrytimes.com | Sydney M Crago |Modern Retina
The US Food and Drug Administration (FDA) has accepted the revised supplemental New Drug Application (sNDA) for Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) on January 6, 2025.
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Jan 7, 2025 | 
optometrytimes.com | Sydney Crago |Modern Retina
The Data and Safety Monitoring Board (DSMB) for the OCU410 ArMaDa clinical trial convened and approved continuation of the second phase of the Phase 1/2 study. The candidate being evaluated, OCU410 (AAV5-hRORA), is a novel modifier gene therapy candidate being developed for geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).
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Dec 9, 2024 | 
optometrytimes.com | Sydney M Crago |Modern Retina
December 9, 2024By The trial is expected to close randomization in early December 2024. More than 300 patients have been randomized in the SOL-1 Phase 3 trial for OTX-TKI (AXPAXLI, axitinib intravitreal implant). The trial is expected to close randomization in early December 2024. This is the first registrational clinical trial of OTX-TKI in wet age-related macular degeneration (wet AMD) and is on track to report topline data in the fourth quarter of 2025.1Pravin U.
