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Latest From Novaliq GmbH

Pharma Looks To America First: US FDA Holds Overwhelming Lead Over EMA In Novel Approvals

A Pink Sheet analysis finds US approval preceded European Union clearance for 80% of products approved in both areas, but when EU approval came first, it beat the FDA by a median of 13 months. US-first approvals came close to six months before the EU.

Regional Comparisons Approvals

OKYO Hits Multiple Dry Eye Endpoints, Plans Move Into Phase III

OKYO’s eye drop OK-101 has hit endpoints for ocular pain, tear film breakup time and conjunctival staining in Phase II, while demonstrating a placebo-like tolerability profile.

Clinical Trials Drug Approval Standards

Bausch + Lomb Dry Eye Franchise Ahead Of Growth Targets

Having acquired Xiidra from Novartis and getting US approval of Miebo in 2023, B+L’s two-product dry eye franchise delivered 66% year-over-year growth during Q4 2023.

Sales & Earnings Business Strategies

Sylentis Piles On Another Failure In Dry Eye

The PharmaMar subsidiary is the latest group to crash in a notoriously hard-to-treat disease, leaving Bausch + Lomb more firmly in command of the field.

Clinical Trials Ophthalmic
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