EU approval for use of Lucentis to treat DME

Article

Novartis has received the eagerly anticipated approval from the European Commission for Lucentis (ranibizumab) to treat visual impairment due to diabetic macular oedema (DME).

Novartis has received the eagerly anticipated approval from the European Commission for Lucentis (ranibizumab) to treat visual impairment due to diabetic macular oedema (DME).

The drug is now being introduced to countries across the EU, including the UK, for the treatment of DME.

Two clinical studies, RESOLVE and RESTORE, were carried out to assess the performance of Lucentis in this patient group, versus sham or laser therapy.

In the RESTORE study patients achieved, on average, 6.8 letters in visual acuity when treated with Lucentis and 6.4 letters when treated with a combination of Lucentis and laser therapy at 12 months. Laser treatment patients only improved by 0.9 letters when measured on a standard ETDRS eye chart.

The RESOLVE study demonstrated that patients gained an average of 10.3 letters in visual acuity versus the sham-treated patients who lost 1.4 letters.

Both studies indicated the occurrence of arterial thromboembolic events (

It was concluded that Lucentis restores patient's independence and provides continuous visual acuity in the treatment of both DME and wet AMD.

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
© 2025 MJH Life Sciences

All rights reserved.