Ophthalmology

Cipla has bolstered its ophthalmology portfolio and increased its global offering after chalking up an agreement to add Formosa Pharmaceuticals’ USFDA-approved clobetasol propionate 0.05% ophthalmic suspension.

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.

Alvotech has followed its European filing for a biosimilar to Regeneron’s Eylea (aflibercept) 2mg with acceptance for review from the US Food and Drug Administration for its AVT06 candidate.

Beyond the cost savings of biosimilars, the true evolution in wet AMD treatment is happening by companies developing next-generation therapies that aim to reduce injection burden, introduce novel mechanisms, and potentially alter disease progression.

GSK’s depemokimab, if approved, could become the first ultra-long-acting drug for treating asthma and chronic rhinosinusitis with nasal polyps. Meanwhile, Sanofi’s teplizumab, which the US approved as the first disease-modifying therapy for type 1 diabetes in 2022, has now been filed for review by the European Medicines Agency.

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

The Swiss-headquartered, NASDAQ-listed group has posted a Phase II win for OCS-05 in acute optic neuritis, which opens up its potential in additional, and much larger, neuro-ophthalmic indications, CEO Riad Sherif tells Scrip.

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.