A new study—published in Optometry and Vision Science and sponsored by Oyster Point Pharma—has found that varenicline solution nasal spray (VNS) is effective against signs and symptoms of dry eye disease (DED) in a range of patients, regardless of disease severity. (via)
Tell me about the study.
Investigators performed an analysis of the integrated data from the ONSET-1 and ONSET-2 clinical trials of varenicline, which tracked the improvement over four weeks of the study eye using the change in Schirmer’s Test Scores and Eye Dryness Scores from baseline.
The analysis in the study identified severity subgroups for mild-moderate and severe DED using baseline ocular assessments from the clinical trial data.
What did they find?
VNS was found to improve the signs and symptoms of DED, regardless of severity. Compared with the vehicle control, patients with both mild-moderate and severe DED were likely to report decreased symptoms and improved Schirmer’s Test Scores of greater than or equal to 10 mm.
Take home.
For a variety of reasons, many clinical trials of treatments for DED focus on severe DED. However, most patients describe their symptoms as mild or moderate.
According to the authors, this means that—in practice—a clinician writing a prescription medication for a patient with mild to moderate DED may have difficulty interpreting the outcomes. The ONSET-1 and ONSET–2 clinical studies enrolled a wider range of patients, demonstrating the importance of reflecting a real-world patient population.