November 19, 2024 1 min read Adverum Biotechnologies reported positive 52-week data from the phase 2 LUNA trial as well as long-term follow-up results from the OPTIC trial of Ixo-vec in patients with wet age-related macular degeneration. “Today’s clinical updates underscore Ixo-vec’s potential best-in-class product profile in wet AMD and highlight that we have … [Read more...] about Adverum reports positive 52-week, 4-year data for wet AMD gene therapy
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FDA issues CRL to Astellas’ Supplemental New Drug Application for avacincaptad pegol intravitreal solution (IZERVAY)
Astellas Pharma Inc. announced the United States Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for avacincaptad pegol intravitreal solution (IZERVAY). In the November 15 CRL, the FDA stated it cannot approve a supplemental New Drug Application in its present form. IZERVAY had an expected Prescription Drug User Fee Act (PDUFA) date of November … [Read more...] about FDA issues CRL to Astellas’ Supplemental New Drug Application for avacincaptad pegol intravitreal solution (IZERVAY)
Ocugen announces positive preliminary data from OCU410 Phase 1 clinical trial for geographic atrophy
Ocugen Inc. today announced positive preliminary efficacy and safety data from the Phase 1 dose-escalation segment of the Phase 1/2 OCU410 ArMaDa clinical trial for geographic atrophy (GA) secondary to dry age-related macular degeneration (dAMD).Key findings include:No drug-related serious adverse eventsReduced lesion growthPreservation of retinal tissueImprovement in … [Read more...] about Ocugen announces positive preliminary data from OCU410 Phase 1 clinical trial for geographic atrophy
Binocular amblyopia home treatment: The next step after patching
Reviewed by Tamara Wygnanski-Jaffe, MD; and Nicholas Sala, DOA binocular, eye tracking–based amblyopia home treatment (CureSight; NovaSight) has been shown to be at least as effective as patching, according to the study's lead author Tamara Wygnanski-Jaffe, MD, of the Goldschleger Eye Institute; head of the Pediatric Ophthalmology and Strabismus Clinic, Sheba Medical Center, … [Read more...] about Binocular amblyopia home treatment: The next step after patching
The macular microvascular changes in children with a history of retinopathy of prematurity treated with intravitreal Bevacizumab injection using optical coherence tomography angiography: a retrospective cohort
Our study aims to evaluate and compare the macular microvascular condition of the intravitreal Bevacizumab (IVB)-treated retinopathy of prematurity (ROP) cases to the preterm cases without ROP and spontaneousl... … [Read more...] about The macular microvascular changes in children with a history of retinopathy of prematurity treated with intravitreal Bevacizumab injection using optical coherence tomography angiography: a retrospective cohort
VIDEO: Cataract surgery planning tools streamline lens calculations, minimize errors
November 18, 2024 3 min watch NEW YORK — In this Healio Video Perspective from OSN New York, John A. Hovanesian, MD, FACS, of Harvard Eye Associates discusses three tools to improve cataract surgery planning. The Veracity surgery planner from Zeiss, the SMARTCataract planner from Alcon and the Eyetelligence platform from Bausch + Lomb are … [Read more...] about VIDEO: Cataract surgery planning tools streamline lens calculations, minimize errors
Ultra-widefield, 7-field imaging show concordance for diabetic retinopathy grading
November 18, 2024 3 min read Key takeaways:Ultra-widefield and 7-field imaging were correlated for all diabetic retinopathy outcomes.Concordance was especially high for severe outcomes.Evaluations of diabetic retinopathy severity appeared comparable with ultra-widefield and 7-field imaging, suggesting ultra-widefield imaging can be used in … [Read more...] about Ultra-widefield, 7-field imaging show concordance for diabetic retinopathy grading
Alkeus Pharmaceuticals receives FDA Rare Pediatric Disease and Fast Track designations for gildeuretinol as treatment for Stargardt disease
Alkeus Pharmaceuticals today announced that gildeuretinol (ALK-001), an investigational oral therapy, has received Rare Pediatric Disease and Fast Track designations from the FDA for the treatment of Stargardt disease.Oral gildeuretinol acetate (ALK-001) is a new chemical entity designed to reduce the dimerization of vitamin A without modulating the visual cycle. In preclinical … [Read more...] about Alkeus Pharmaceuticals receives FDA Rare Pediatric Disease and Fast Track designations for gildeuretinol as treatment for Stargardt disease
Biosimilar referencing aflibercept from Samsung Bioepis approved by European Commission
The European Commission (EC) has approved OPUVIZ 40 mg/mL solution for injection in a vial. OPUVIZ is a biosimilar referencing Eylea (aflibercept). The biosimilar has been developed and registered by Samsung Bioepis.The biosimilar now known by the brand name OPUVIZ was previously known as the biosimilar candidate SB15. It has been approved for use in adult patients for the … [Read more...] about Biosimilar referencing aflibercept from Samsung Bioepis approved by European Commission
VIDEO: Pros, cons of complement inhibitors debated at AAO meeting
November 18, 2024 2 min watch CHICAGO — In this video, Joan W. Miller, MD, chair of ophthalmology at Mass Eye and Ear, discusses controversies surrounding the use of complement inhibitors for the treatment of geographic atrophy. “Complement inhibitors that were approved are still somewhat controversial, and it still generates a pretty lively discussion,” Miller … [Read more...] about VIDEO: Pros, cons of complement inhibitors debated at AAO meeting