Ophthalmology

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

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

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.

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

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.

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 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.

With the US FDA approval in its pocket, Celltrion now has to wait for the outcome of litigation with originator Regeneron to launch its Eydenzelt aflibercept biosimilar.

Another biosimilar sponsor has put pen to paper on a settlement agreement allowing for launch of a US Eylea (aflibercept) rival in the second half of 2026.

Boehringer Ingelheim's collaboration with Re-Vana Therapeutics is the most recent step in the German pharma’s paradigm shift toward earlier intervention in retinal diseases.