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If both of these therapies go on to win FDAapprovals, Novaliq and Bausch + Lomb will likely be in a strong position to compete against the current market players. TRPM8 receptors are associated with the detection of ocular surface dryness and are activated by evaporative cooling and hyperosmolarity, which can lead to tear production.
Pharmaceutical companies – and the FDA – are embracing FDCs. From 1990 through 2013, the FDAapproved 131 FDC products, on average 5.7 Companies can save valuable time and resources as well by taking advantage of the FDA’s 505(b)(2) approval pathway. More FDC products flowing into pharma pipelines.
Furthermore, the bioavailability of the active pharmaceutical ingredient (API) into the cornea is up to four times stronger with EyeSol technology. One such approved medication is Miebo , an ophthalmic solution developed by Bausch + Lomb and Novaliq.
It was engineered to have high potency, bioavailability and kinase selectivity that led to improved efficacy and safety in B-cell malignancies. Zanubrutinib has five US Food and Drug Administration (FDA)-approved indications and the broadest label in its class.
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