Bausch + Lomb and Novaliq Receives the US FDA’s Approval of Miebo for Signs and Symptoms of Dry Eye Disease
Shots:
- The US FDA has approved Miebo (perfluorohexyloctane ophthalmic solution) for the treatment of the signs and symptoms of dry eye disease (DED). The therapy is expected to be commercially available in H2’23
- The approval was based on the P-III (GOBI) & (MOJAVE) trials evaluating Miebo in a ratio (1:1) in 1200 patients with a history of DED and clinical signs of Meibomian gland dysfunction, showed that Miebo met both primary sign and symptom efficacy EPs. The two 1EPs were change from baseline at 8wk. in total corneal fluorescein staining (tCFS) and eye dryness Visual Analog Scale (VAS) score
- Patients experienced relief of symptoms as early as 15Day and through Day 57 with reduction in VAS eye dryness score & tCFS favoring MIEBO
Ref: Businesswire | Image: Novaliq
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