Tyrvaya shows consistent outcomes regardless of menopause status
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MONTEREY, Calif. — Women treated with Tyrvaya had consistent outcomes regardless of their menopause status, according to a study presented at the Women in Ophthalmology Summer Symposium.
Dagny Zhu, MD, and colleagues wrote in a poster presentation that post-menopausal women are at greater risk for dry eye disease (DED) due to hormonal dysregulation of ocular secretory glands.
“By activating the trigeminal parasympathetic pathway, OC-01 (varenicline solution nasal spray 0.03 mg, Oyster Point Pharma), a cholinergic agonist, is believed to increase endogenous tear production,” they wrote.
The efficacy of OC-01, which is now known as Tyrvaya, compared with vehicle control on DED signs and symptoms was evaluated in post-menopausal and not post-menopausal women from the ONSET-1 and ONSET-2 clinical trials.
The post hoc analysis included data from 449 participants who received either OC-01 or vehicle control. The primary outcomes included Schirmer’s test score and change in eye dryness score from baseline to week 4.
There was no interaction between treatment effect and menopausal status. The odds of achieving at least 10 mm improvement in Schirmer’s test score were 3.45 in the treatment arm and 3.25 in the vehicle control arm.
“OC-01-treated subjects showed similar [Schirmer’s test score] and [eye dryness score] outcomes compared to [vehicle control] regardless of menopausal status,” Zhu and colleagues wrote. “Although hormonal changes may contribute to worsening DED post-menopause, OC-01 demonstrated consistency of treatment effect compared to vehicle control regardless of [baseline] menopausal status.”
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Zhu D, et al. Evaluation of OC-01 (varenicline solution) nasal spray 0.03 mg effectiveness based on menopausal status: Post-hoc analysis of ONSET-1 and ONSET-2 clinical trials. Presented at: Women in Ophthalmology Summer Symposium; Aug. 25-28, 2022; Monterey, California (hybrid meeting).
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