If the spray is spread on the noses, the patients ’eyes will water. It also makes them sneeze, but it doesn’t irritate their eyes like many eye drops do, said Michael Raizman, MD, an associate professor of ophthalmology at Tufts University School of Medicine in Boston, Massachusetts.
This is because Oyster Point’s OC-01 works by simulating the trigeminal nerve through the nasal passage, causing the eyes to break. In contrast, most current treatments are anti-inflammatory or artificial tears which do not include all the components of the natural ones.
OC-01 also improves symptoms relatively quickly, in as little as 14 days, instead of the 3-6 months needed for other dry eye treatments, Raizman said. Medscape Medical News by mail.
Raizman presented the results of the ONSET-2 phase 3 trial at the 2021 annual meeting of the Virtual Association for Research in Vision and Ophthalmology (ARVO).
Marketed as an oral drug Chantix, from Pfizer, varenicline is prescribed to reduce cigarette cravings. Administered as a nasal spray for dry eye, much less ends up in the bloodstream, Raizman said.
To test their effectiveness, the researchers recruited people with dry eye disease as measured by a Schirmer score of 10 mm or less and an eye surface disease index score of 23 or less. They randomly assigned 246 patients to take 1.2 mg / ml, 260 patients to take 0.6 mg / ml, and 252 patients to take the vehicle as a placebo, twice a day.
Patients were allowed to use artificial tears and sprays. After 4 weeks, approximately half of the subjects in the two varenicline groups had improvements of at least 10 mm in the Schirmer test compared with approximately a quarter of those in the placebo group, a difference that was statistically significant (Pg <.0001).
The mean difference in improved Schirmer score was also significantly greater in the two groups of patients who received OC-01 than in the control group.
And the mean change in dry eye score (EDS), according to which patients rated their symptoms on a scale of 1 to 100, was slightly better for those who received OC-01 than those who received OC-01. placebo.
Average changes from baseline to week 4
|Schirmer score, mm||Dry eye score (0-100)|
|OC-01 0.6 mg / mL, n = 255||11.3||-19.8|
|OC-01 1.2 mg / mL, n = 242||11.5||-22.2|
|Placebo, n = 248||6.3||-15.4|
The difference between the 0.6 mg / ml group and placebo barely reached statistical significance (Pg = 0.038), but was stronger for the highest dose (Pg = 0.001). Some data had to be imputed because the restrictions imposed by COVID-19 prevented it from being collected.
Almost everyone who suffered from OC-01 sneezed, but only 12% had some ocular adverse event, similar to the placebo group. No one reported burns or eye bites.
Some patients coughed or felt irritation in the throat or nose. Eight people discontinued the drug due to adverse reactions in the 1.2 mg / ml group, compared with 5 in the 0.6 mg / ml group and 4 in the placebo group.
Combining ONSET 2 data with ONSET 1 phase 2 trial data to create a larger sample size, the researchers separated patients with mild to moderate symptoms from those with severe symptoms. The mild to moderate group experienced only a slight improvement in symptoms. People with severe symptoms achieved a 31.4-point improvement in EDS (regardless of dose), which was slightly better than the 23.6-point improvement provided by placebo.
Oyster Point has applied for approval from the U.S. Food and Drug Administration (FDA) and hopes to meet again on October 17, 2021.
Anat Galor, MD, MSPH, clinical spokesperson for the American Academy of Ophthalmology and associate professor of ophthalmology at the University of Miami School of Medicine in Florida, said he hopes to have another alternative to treat eye disease secs.
He said it is difficult to correlate an EDS improvement of about 20 points with what his patients experience Medscape Medical News. “No one questions whether nasal spray increases tearing, because that’s the biology of spray,” he said. “The question is: how does this translate into patient symptoms and function?”
Some tips come TrueTear, a device manufactured by Allergan that electrically stimulates the anterior ethmoidal nerve through the nasal passage to cause tears. It benefited some patients who had not obtained medication relief. But the gadget was expensive and Allergan withdrew it in 2020. “One of the things that posed a bit of a challenge was getting those wings up,” Galor said.
A new device, the iTear100, from Olympic Ophthalmology, which stimulates the anterior ethmoidal nerve by the side of the nose, received FDA approval last year.
“I’m excited to have more products that are targeted at different aspects of the disease,” Galor said. “The idea that we’re thinking beyond inflammation is what excites me the most.”
Oyster Point funded the study. Galor did not report any relevant financial reports. Raizman is a consultant for Oyster Point.
Laird Harrison writes about science, health, and culture. His work has appeared in national magazines and newspapers, on public radio and on websites. He is working on a novel about alternative realities in physics. Harrison teaches writing at the Writers Grotto. Visit it at www.lairdharrison.com or follow him Twitter: @LairdH.