SEP 28, 2018
Comprehensive Ophthalmology, Retina/Vitreous
A weekly roundup of ophthalmic news from around the web.
Luxturna is poised to become the first and only gene therapy available in Europe to treat inherited retinal diseases. The European Medicines Agency's Committee for Medicinal Products for Human Use has announced their support for single doses of voretigene neparvovec to treat patients with mutations in both copies of the RPE65 gene. The approval paves the way for Novartis to commercialize Luxturna in markets outside the U.S. Novartis
Novartis’ new anti-VEGF agent outperformed aflibercept in phase 3 trials of people with neovascular AMD, the company reported last week. Investigators unveiled interim findings from the HAWK and HARRIER trials at EURETINA 2018, noting that brolucizumab (6 mg) was superior to aflibercept (2 mg) in resolving retinal fluid between weeks 36 to 48. Novartis
The GS-1 gonioscope is the first automated device to perform 360° color iridocorneal angle imaging, according to NIDEK. “Different from classic gonioscopy, patient diagnosis can occur after image acquisition rather than at the time of assessment. Images can be easily shared with referring physicians and used for patient education.” NIDEK
PRIMA, a miniature wireless subretinal implant, has restored perception of bars, letters, numbers and light to 5 patients with advanced dry AMD. Pixium Vision reported the preliminary findings of their feasibility trial earlier this week. The company plans to embark on a large European clinical trial required for the CE mark in 2019. Pixium Vision
The U.K.’s National Health Service has declared victory in a legal fight against Novartis and Bayer, who opposed the off-label use of Roche’s Avastin (bevacizumab) for the treatment of wet AMD. High Court Mrs. Justice Whipple called the pharma giants’ argument an “absurd proposition” and ruled against them. A series of investigations by The BMJ previously found that doctors had been deterred from prescribing off-label bevacizumab through a combination of legal threats, misinformation, anticompetitive behavior and lobbying. The British Medical Journal