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.

Related Videos
Penny A Asbell, MD, FACS speaks at the 2023 AAO meeting
Dr Mary Elizabeth Hartnett speaks with David Hutton of Ophthalmology Times
Esen K. Akpek, MD, Professor at the Wilmer Eye Institute, Johns Hopkins University School of Medicine, converses via zoom with David Hutton of Ophthalmology Times
Dr Ali Erginay discusses his EURETINA presentation
Related Content
Rob Thornhill, CEO, Centricity Vision, at AAO 2023

AAO 2023: Company updates from Centricity Vision CEO Rob Thornhill

November 28th 2023
Article

At this year's American Academy of Ophthalmology meeting in San Francisco, California, Rob Thornhill, CEO of Centricity Vision, spoke with the Ophthalmology Times team about developments in the company's ZEPTOLink IOL positioning systems.

A person holds a phone in their hand. Above the phone, icons such as a cross, a pill, a wheelchair and a syringe indicate they are looking at health information. Image credit: ©Monster Ztudio – stock.adobe.com

Harnessing digital media for enhanced patient engagement and outcomes

November 27th 2023
Article

Patients who received digital education demonstrated a better understanding of their disease and its management

Marco A. Zarbin, MD, PhD, Professor of Ophthalmology, Rutgers New Jersey Medical School

AAO 2023: Marco A. Zarbin, MD, PhD, provides analysis of the YOSEMITE and RHINE clinical trials

November 24th 2023
Article

At this year's American Academy of Ophthalmology meeting in San Francisco, California, Marco A. Zarbin, MD, spoke with Ophthalmology Times about his team's post-hoc analysis of the YOSEMITE and RHINE clinical trials

Image credit: ©arcyto – stock.adobe.com

The next frontier in cell therapy: An ethically responsible management model

November 20th 2023
Article

Infrastructure across Europe needs a major overhaul to optimise education and patient access in groundbreaking treatments

A photo of a hospital hallway. Image credit: ©By ANDREW NORRIS – stock.adobe.com

Former NHS secretary found guilty of illegally accessing medical records

November 17th 2023
Article

A patient filed a complaint in June 2019 claiming their medical records had been accessed by an NHS employee

An illustration of a punctal plug. A caption says the tapered tip is 0.25 mm wide and the bulk of the plug is 0.6 mm wide, which results in the ability to insert the plug into most punctal openings.

New shape for an old device: A punctal plug that better fits into the punctum

November 17th 2023
Article

Larger 0.6-mm temporary plug features a tapered edge

© 2023 MJH Life Sciences

All rights reserved.