Astellas said in a press release that the FDA comments in the CRL relate to proposed labeling language, not safety.

Key findings include reduced lesion growth, retinal tissue preservation, and improved visual function, demonstrating significant potential for the treatment option.

The designations underscore the unmet need in Stargardt disease, a rare and serious pediatric disease for which no treatment exists.

The biosimilar now known by the brand name OPUVIZ was previously known as the biosimilar candidate SB15.

This retrospective cohort study was designed to provide further information on the association between BP parameters and VF progression over time.

Emmecell announced positive Phase 1 extension study results for EO2002, a nonsurgical cell therapy for corneal edema. The therapy improved vision, reduced central corneal thickness, and demonstrated strong safety, offering an alternative to corneal transplants.

Retreatment rates are lower, with few orbit decompression procedures.

This Week in Ophthalmology is a weekly video series highlighting the latest news and articles featured on the Ophthalmology Times website.

A coalition of eye health advocacy groups vocalized support for the legislation

HelpMeSee’s Mazava Project trains general practitioners in Madagascar to perform cataract surgeries, addressing the country’s high rate of avoidable blindness. Trainees gain proficiency through simulation-based learning and live surgeries, improving access to eye care in remote areas.

Livionex, recently announced a successful end-of-Phase 2 meeting with the FDA, supporting the advancement of C-KAD, a 2.6% EDTA ophthalmic solution, to a Phase 3 clinical study. In an interview with Ophthalmology Times, Randall Olson, MD, lead author and a Distinguished Professor at the University of Utah, Chair of the Department of Ophthalmology and Visual Sciences, and CEO of the John A. Moran Eye Center, discusses the ongoing research.

Sumit Sharma, MD, FASRS asks the panel what they are using for first-line AMD treatment and what considerations factor into decision making, such as insurance coverage or risk of inflammation.

In the first case, David Lally, MD presents a patient case of age-related macular degeneration (AMD) highlighting the superior durability of newer treatments.

Afqlir (aflibercept) is a 2 mg vial kit and pre-filled syringe for intravitreal injection.

Prevent Blindness has designated November 18 to 24, 2024, as the 5th annual Thyroid Eye Disease (TED) Awareness Week. The week aims to raise awareness of TED's symptoms, impact on vision and mental health, and new treatment options. Educational resources and expert-led episodes will support patients and healthcare professionals.