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Ophthalmology

Alvotech Secures Immediate Launch Of Eylea Biosimilar In The UK And Canada

Alvotech has ticked off all of the remaining patent-related matters for its aflibercept biosimilar, with multiple market entries expected in 2026.

Five Chinese Biotechs Tap IPOs To Study First-In-Class Candidates Overseas

Multiple Chinese biotechs are seeking to raise new funds through IPOs on the Hong Kong and Beijing stock exchanges to support international clinical trials for their first-in-class molecules.

Ocugen’s ArMaDa Trial Sails With Positive Data For OCU410

The company announced positive preliminary results from its Phase II study of the gene therapy in geographic atrophy secondary to dry age-related macular degeneration.

Amneal Scores Dual FDA Wins In High-Value Complex Generics

Back-to-back FDA nods for generic Restasis and ProAir highlight Amneal’s growing strength in complex sterile and inhalation manufacturing.

Celltrion’s Eydenzelt Becomes Third Aflibercept Biosimilar Approved In Canada

Korean firm’s Eydenzelt biosimilar win full label alignment with Eylea, including all approved ophthalmic indications.

Formycon Expands European Aflibercept Footprint With NTC Deal In Italy

Deal gives NTC exclusive rights to commercialize Formycon and Klinge’s Baiama aflibercept biosimilar in Italy, expanding Formycon’s growing network of European ophthalmology partners.

‘Never In Doubt’: Alvotech Dodges UK Injunction To Prepare For EU Aflibercept

UK ruling clears the way for Alvotech to stockpile its aflibercept biosimilar ahead of Eylea’s SPC expiry later this month, positioning the firm for a day-one launch across Europe and the UK.

Outlook Therapeutics Takes Another Shot At US Approval For Ophthalmic Bevacizumab

Outlook Therapeutics believes its revised filing addresses the FDA’s sole remaining concern from an August complete response letter, setting up a potential mid-2026 decision on its wet AMD therapy.

Pharma BD Leaders Navigate Uncertainty And Opportunity

Pharma business development teams are adapting M&A and licensing strategies amid market volatility and looming patent cliffs.

NovaBridge To Move Vabysmo Follower Into Phase III Head-To-Head Trial

On the back of long-term durability data expected from a Phase II study in the fourth quarter, NovaBridge plans to advance VIS-101 into a Phase III head-to-head trial against Roche’s Vabysmo.

Epioxa’s FDA Approval Marks New Era In Corneal Cross-Linking, Says Glaukos

Glaukos’ FDA approval for Epioxa (riboflavin 5'-phosphate) under the 505(b)(2) pathway marks a major advance in keratoconus care, offering a less invasive, epithelium-on alternative that is set to launch in early 2026 with patient access programs.

Xbrane’s US Approval Bid For Ranibizumab Biosimilar Stalls Again After FDA Review

Xbrane Biopharma has suffered yet more frustration in its attempt to win US approval for its proposed Lucamzi biosimilar to Lucentis, receiving another knockback from the FDA that has forced it to reorganize its finances.