2023-05-18 14:49:00 ET
Bausch + Lomb ( NYSE: BLCO ), the eyecare spinoff of Canadian pharma Bausch Health ( BHC ) and its partner Novaliq GmbH announced Thursday the FDA approval of Miebo to treat dry eye disease (DED).
The companies said that Miebo, formerly NOV03, is the first and only FDA-approved eye drop designed to directly target tear evaporation in DED, one of the most common ocular surface disorders among Americans.
The FDA’s decision is backed by data from two 57-day, randomized, saline-controlled trials called GOBI and MOJAVE, which reached the primary endpoints for DED signs and symptoms.
The commonest adverse reactions linked to Miebo were found to be blurred vision (1.3-3%) and eye redness (1-3%).
“MIEBO becomes our first prescription pharmaceutical eye treatment to be approved by the FDA since becoming an independent, publicly traded eye health company,” President of Bausch + Lomb’s ( BLCO ) Ophthalmic Pharmaceuticals Andrew Stewart noted.
More about Bausch + Lomb
- Bausch Health calls Bausch + Lomb an unrestricted subsidiary
- Bausch + Lomb: Shares Remain A Hold, Near Fair Value, Watch For H2 Catalysts
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Bausch + Lomb and Novaliq win FDA nod for dry eye disease therapy