FDA Approvals, Highlights, and Summaries: Ophthalmology 

February 17, 2022

Tyrvaya (varenicline intranasal)

Varenicline intranasal is indicated for treatment of signs and symptoms of dry eye disease. Varenicline binds to highly selective heteromeric subtype(s) of the nicotinic acetylcholine receptor, which produces agonist activity and activates the trigeminal parasympathetic pathway resulting in increased production of basal tear film. The parasympathetic nervous system controls tear film homeostasis, partially via the trigeminal nerve, which is accessible within the nose.

Approval was supported by the ONSET-2 phase 3 trial (n = 758). A statistically significantly greater percentage of patients achieved a 10-mm improvement or more in Schirmer’s test score at Week 4 in both varenicline intranasal treatment groups compared to vehicle (0.6 mg/mL, 47.3%; 1.2 mg/mL, 49.2%; vs. vehicle, 27.8%; P<0.0001 for both doses). Ophthalmology. 2021 Nov 9

Other ophthalmology approvals

Vuity (pilocarpine ophthalmic) - New strength and indication approved for presbyopia in adults.

Dextenza (dexamethasone ophthalmic insert ) - New indication for ocular itching associated with allergic conjunctivitis.

Susvimo (ranibizumab intravitreal implant) - Indicated for treatment of neovascular (wet) age-related macular degeneration (ARMD) in adults who have previously responded to at least 2 intravitreal injections of a vascular endothelial growth factor (VEGF) inhibitor.

Byooviz (ranibizumab intravitreal injection) - First biosimilar to Lucentis approved for ARMD.

Verkazia (cyclosporine ophthalmic) - Indicated for vernal keratoconjunctivitis in adults and children aged 4 years and older.


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