Sheppard J, Bergmann M, Schechter BA, et al. - Researchers present a phase 3 worse-eye efficacy analysis and a 1-year open-label extension assessing the long-term safety of OTX101 0.09% in keratoconjunctivitis sicca (KCS), also known as dry eye disease. Patients with bilateral KCS were randomized 1:1 to 12 weeks OTX-101 or vehicle 1 drop per eye twice daily during the double-masked treatment phase. All individuals who finished the treatment phase were eligible for registration in the open-label extension and received 1 drop OTX-101 twice daily for up to 52 weeks. Overall, 745 and 258 patients registered in the treatment and safety extension phases, respectively. The efficacy of OTX-101 in the eye was confirmed with a lower Schirmer baseline score. In the long term, OTX-101 was well tolerated.