Study: Varenicline nasal spray shows positive safety and tolerability profile

Leslie O'Dell, OD, FAAO, medical director of Medical Optometry America, shares new research around OC-01 (varenicline solution) nasal spray, presented during the 2022 American Optometric Association (AOA) Optometry's Meeting.

This transcript has been lightly edited for clarity:

Hi I'm Dr. Leslie O'Dell with Medical Optometry America at AOA to present some exciting new research around OC-01 (varenicline solution) nasal spray.

What the data looked at was integrated data from onset one and onset two, and it was stratified between signs and symptoms. So we looked at data comparing if the Schirmer score was five millimeters or less, so more of a moderate to severe dry patient, compared to those who are greater than five millimeters on Schrimer.

We also looked at eye dryness scores, which was a zero to 100 scale and mapped that out whether it was mild or more moderate to severe with a 60 being the cut off, and we looked at just the overall effect that varenicline nasal spray 0.3 milligrams had on overall improvement in Schirmer scores from baseline to week four in these subgroups, and also what percent of patients were able to achieve a 10 millimeter or more increase in their Schirmer scores baseline to week four.

So the data is pretty exciting. In the overall group for just baseline to week four, we saw a 5.5 millimeter increase in Schirmer scores across the board, whether we're dealing with a more mild or moderate to severe dry eye patient when compared to vehicle.

If you take a look at that percent and how that translates into the percent of patients that were able to achieve a 10 millimeter or war gain on Schirmer scores, the odds ratio shows about a 2.84 times rate for that to happen in the treatment group when compared to vehicle.

What our study also showed was a really great safety and tolerability profile. So the biggest adverse event that was seen in this study was sneezing. And overtime, we were able to show that that sneeze effect that a patient would get when they were administering, actually both the vehicle and the medication, would improve over time. Sometimes there was also some installation site irritation of the nasal passageway, as well as a mild cough that was seen in patients, but overall a really great safety and tolerability profile.

So varenicline nasal spray is now commercially available as TYRVAYA® since October 2021. And we can now prescribe it and it's a great way to actually target basil to your production for your patients. So it's stimulating this trigeminal parasympathetic pathway by acting on a nerve which is right inside the nasal pathway which we can achieve now a non-ocular surface and ocular-sparing treatment for our patients with chronic dry eye disease.