Ophthalmic

Harrow is taking aim at launching new partner Samsung Bioepis’ Byooviz biosimilar to Lucentis in 2026.

PCH lowers full-year guidance even after reaching $100m deal to acquire Canadian sterile ophthalmic manufacturer for its Clears Eyes line troubled by supply slumps for several years. Its $47.5m reported net sales for April-June period were down 6% from a year ago.

Jason Menzo, CEO of the Foundation Fighting Blindness, says the organization is adapting its funding strategy, navigating regulatory challenges and accelerating the translation of academic discoveries into industry-led clinical development.

CEO Len Schleifer said during the company’s first quarter earnings call that most of the complete response letters the company has received related to third-party suppliers, not efficacy or safety.

CEO Len Schleifer explained on the company’s Q1 earnings call that most of the complete response letters the company has received related to third-party suppliers, not efficacy or safety.

The company closed a $150m series C funding round shortly after opening the second part of its Phase I/II study of ATSN-201 and partnering with a Nippon Shinyaku on ATSN-101.

Several new drugs that are yet to be approved anywhere in the world are now under review by the European Medicines Agency for potential pan-EU marketing authorization.

Aurion Biotech is developing a cell therapy for corneal diseases that is cheap enough to produce and can be scaled that it should reach the masses in a way that other cell therapies cannot.

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.

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.