Glaucoma is a progressive optic neuropathy associated with increased intraocular pressure (IOP; normal range 8-22 mm Hg), which is the only disease-related factor that can be modified. Topical drugs that lower IOP are the first line of treatment for open-angle glaucoma.
CHOICE OF TOPICAL DRUGS — For initial treatment, topical prostaglandin analog (PGA) monotherapy is preferred. If the PGA lowers IOP into the target range, no additional treatment is necessary. If it substantially decreases IOP but falls short of achieving the target range, another topical drug, such as a beta blocker or a carbonic anhydrase...
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RELEASE
Omlyclo (omalizumab-igec; Celltrion), a biosimilar product interchangeable with the recombinant anti-IgE monoclonal antibody Xolair, has been approved by the FDA for same indications as Xolair (see Table 1). Omlyclo is the first Xolair biosimilar to be approved in the US.
REGULATORY STATUS — A biosimilar is a biologic product that is highly similar in composition and strength and has no clinically meaningful differences in safety, purity, and potency to the FDA-approved reference product. For a biosimilar to be approved as an interchangeable product, the manufacturer generally conducts clinical trials to prove that the results will be the same if the patient switches between the reference product and the biosimilar. In clinical studies, there were no clinically significant differences in efficacy, …