Ophthalmology

Patients in the ICU continue to die from SARS-CoV-2-induced acute respiratory distress syndrome, says InflaRx, which is one of companies whose product the European Medicines Agency today announced should be approved for marketing in the EU.

The European Medicines Agency’s human medicines committee is meeting this week due to decide whether or not to back pan-EU marketing approval for a number of new drugs.

Up to 40,000 people could be set to access Outlook Therapeutics’ Lytenava in England, according to health technology assessment institute NICE, which found the drug for wet age-related macular degeneration had similar health benefits to aflibercept and ranibizumab, and similar costs to aflibercept.

All eyes are on Eylea, after Amgen said last week that it would launch the first US biosimilar in the face of ongoing litigation. The California-based player has spoken of its prospects in the wet-AMD space, including a desire to chart its own path amid supply shortages for Avastin.

Medtech Insight spoke with Vicky Demas, CEO of Identifeye, about plans for bringing the company’s AI-powered retinal screening system for early detection of diabetic retinopathy to primary care facilities. More than 50% of the roughly 38 million Americans who have diabetes skip retinal screenings at present, increasing risk of developing the leading cause of blindness in adults.

The sponsors of medicines that are nearing the end of the regulatory review cycle in the EU could this week be asked to explain why the European Medicines Agency should recommend approving their products.

The US FDA released six more device classifications in early September, including products from Edwards, Interscope, and Baxter Healthcare.

The program, which brings together innovators and device industry stakeholders, helps ease the path to market for novel devices. 

Notal Vision, a Virginia-based patient-centric ophthalmic remote monitoring services provider, has won de novo marketing authorization from the US FDA for a product that allows patients to keep tabs on their age-related macular degeneration while at home.

The Belgian start-up is developing a scleral contact lens with an inbuilt LCD screen capable of filtering light – offering a non-surgical solution to a variety of ophthalmic conditions.