Safety, adherence and discontinuation in varenicline solution nasal spray clinical trials for dry eye disease

Abstract

Aim: Herein, we report safety outcomes for varenicline solution nasal spray (VNS) within the context of clinical trial discontinuation, contrasting those with discontinuation outcomes from topical cyclosporine and lifitegrast clinical trials. Materials & methods: 1061 subjects were randomized across three clinical trials to receive either VNS 0.06 mg, VNS 0.03 mg, VNS 0.006 mg or vehicle control. Subjects who discontinued from treatment were noted and assigned to their appropriate categories. Results: Despite treatment emergent adverse events, 93.5% of subjects receiving VNS completed the treatment period. By comparison, only 80% of subjects in the integrated clinical trials for cyclosporine ophthalmic emulsion and 91% of subjects in the integrated trials for lifitegrast ophthalmic solution completed the full treatment period, respectively. Conclusion: In clinical trials, VNS demonstrated improvements in dry eye disease signs and symptoms, was well-tolerated, and had an overall completion rate >93%. Conventional dry eye treatments (e.g., cyclosporine and lifitegrast) noted considerably higher discontinuation rates in their clinical trials. Plain language summary What is this article about? Varenicline solution nasal spray (TYRVAYAR®; Oyster Point Pharmaceuticals, Princeton, NJ) is FDA approved for the treatment of signs and symptoms of dry eye disease. It is the first and only nasal spray specifically approved for the treatment of any ocular disorder. What were the results? In clinical trials, OC-01 VNS was well tolerated, with over 93% of subjects completing the studies. Ocular adverse events were seen in <5%. Other pharmaceuticals for dry eye disease showed poorer tolerability and higher discontinuation rates in their respective clinical trials. What do the results of the study mean? Products with better tolerability may allow for greater treatment adherence, and potentially better outcomes. Tweetable abstract: Varenicline solution nasal spray displayed excellent safety in clinical trials as well as greater tolerability and lower discontinuation rates than dry eye disease competitors in their respective clinical trials.