Ophthalmology

The firms recently announced they will operate as combined company LXE Hearing marketing Eargo’s namesake line and hearX’s Lexie brands. Eargo majority owner Patient Square Capital added $100m to its investment.

The firms recently announced they will operate as combined company LXE Hearing marketing Eargo’s namesake line and hearX’s Lexie brands. Eargo majority owner Patient Square Capital added $100m to its investment.

Henlius has reported progress in its development of a bevacizumab product for treating ophthalmic diseases, with its Essex-partnered HLX04-O candidate meeting its primary endpoint in a Phase III trial. Meanwhile, Outlook Therapeutics has taken another shot at getting its own ophthalmic bevacizumab approved in the US after resubmitting its filing.

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.