Setback for Genentech

Article

The FDA has denied Genentech's request to fast-track the application for its age-related macular degeneration (AMD) agent, Lucentis (ranibizumab). In response, Genentech announced it plans to file a complete Biologics License Application (BLA) for Lucentis for the treatment of neovascular AMD in December 2005, in a bid to speed up the process. Although the FDA rejected Genentech's request for fast-track designation, this should not affect the timing for BLA submission or the potential to obtain priority review.

Recent Videos
Anat Loewenstein, MD, speaks about the 22nd Annual Angiogenesis, Exudation, and Degeneration Meeting in February 2025 and shares her global forecast for AI-driven home OCT
Sarah M. Thomasy, DVM, PhD, DACVO, a veterinary ophthalmologist at UC Davis, talks about how her research at the Glaucoma 360 symposium
I. Paul Singh, MD, an anterior segment and glaucoma specialist, discusses the Glaucoma 360 conference, where he participated in a panel discussion on the use of artificial intelligence (AI) in glaucoma care.
Charles Wykoff, MD, PhD, discusses his Floretina ICOOR presentation topic, retinal non-perfusion in diabetic retinopathy, with David Hutton, editor of Ophthalmology Times
Elizabeth Cohen, MD, discusses the Zoster Eye Disease study at the 2024 AAO meeting
Victoria L Tseng, MD, PhD, professor of ophthalmology and glaucoma specialist, UCLA
Brent Kramer, MD, of Vance Thompson Vision speaks at the 2024 AAO meeting
Related Content
Five graphics: an eye, a checklist, a target/arrow, a brain, and a heart being held in two hands.

Why education must extend beyond patients to make a difference in diabetic eye disease

Hattie Hayes
February 24th 2025
Article

Francesco Bandello, MD, FEBO, discusses the Diabetic Eye Conditions Coalition and a five-point call to action

Higher molar dose and its translation into clinical practice. Led by John Kitchens, MD; Joined by Peter Kaiser, MD

Higher Molar Dose and Its Translation into Clinical Practice

John Kitchens, MD;Peter Kaiser, MD
July 22nd 2024
Podcast
The Voyager Direct Selective Laser Trabeculoplasty device. Image courtesy of Alcon.

Alcon launches Voyager direct selective laser trabeculoplasty device in the US

Sheryl Stevenson
February 21st 2025
Article

Voyager DSLT is already available in select markets in the EU and the UK, and reduces the specialised training required with manual selective laser trabeculoplasty

A patient undergoes eye surgery, surrounded by doctors in protective surgical gear. Image credit: ©st.kolesnikov – stock.adobe.com

Postoperative considerations for retinal detachments following keratoprosthesis implantation

Lynda Charters
February 21st 2025
Article

Risk factors vary in both short-term and long-term periods following Boston Type 1 keratoprosthesis surgery

An illustration of kidneys, in black-and-white, with color over some sections to indicate disease. Image credit: ©Crystal light – stock.adobe.com

EMA validates indication extension application of pegcetacoplan for treatment of kidney disease

Hattie Hayes
February 20th 2025
Article

According to Apellis and Sobi, pegcetacoplan (Aspaveli) first received marketing authorisation for treatment of paroxysmal nocturnal hemoglobinuria

A sick child in bed holds her stuffed teddy bear. An adult takes the sick child's temperature on a digital thermometer. Image credit: ©Alexis Scholtz/peopleimages.com – stock.adobe.com

Hyperacute outer retinal dysfunction may be an underrecognised paediatric disorder

Lynda Charters
February 20th 2025
Article

Children experienced sudden vision loss, visual field constriction, nyctalopia and dyschromatopsia following febrile illness

© 2025 MJH Life Sciences

All rights reserved.