Partners Bausch + Lomb and Germany-based Novaliq announced that the U.S. regulator has approved their eye drop solution for the treatment of dry eye disease (DED), making it the first and only FDA-approved treatment for DED that directly targets tear evaporation.
A leading cause of DED is excessive tear evaporation, which due to an altered tear lipid layer, is often associated with the clinical signs of Meibomian gland dysfunction (MGD). The new drug, branded as Miebo, is designed to reduce tear evaporation at the ocular surface.
The approval was supported by two phase 3 pivotal clinical trials which enrolled more than 1,200 patients with a history of DED and clinical signs of MGD. Miebo consistently met its primary clinical sign and patient-reported symptom endpoint.
Back in 2019, Bausch Health signed a deal with Novaliq to acquire the exclusive license for the commercialization and development of the treatment in the U.S. and Canada. The financial terms of the deal were not disclosed.
Novaliq is also waiting on its own DED approval. CyclASol, a first-of-its-kind anti-inflammatory product for the treatment of DED, has a PDUFA target action date of June 8, 2023.
