Nasal spray treatment increases Schirmer’s scores in phase 3 trial
The OC-01 nasal spray uses neurostimulation to produce natural tears.
A nasal spray with a unique mode of action could serve patients with dry eye disease who cannot effectively use or who may not want to use eye drops, according to Francis S. Mah, MD.
Oyster Point Pharma’s OC-01 nasal spray is a selective nicotinic acetylcholine receptor agonist, which met its primary endpoint of increased Schirmer’s score in the ONSET-2 phase 3 trial.
“It is novel in terms of its mechanisms. It’s not an anti-inflammatory or something that is immunomodulatory in general. It’s stimulating nerve fibers. It’s activating real tears, which is a very unique aspect. You could theoretically use this in concert with other medications that are FDA approved for dry eyes,” Mah said.
Top-line phase 3 results
The ONSET-2 multicenter, double-masked, randomized, controlled study evaluated the safety and efficacy of OC-01 (varenicline) at two doses compared with vehicle in 758 patients. Researchers evaluated the percentage of patients gaining 10 mm or greater on Schirmer’s score in both doses compared with controls.
Participants with diagnosed dry eye disease were randomly assigned 1:1:1 to receive 1.2 mg/mL of OC-01, 0.6 mg/mL of OC-01 or vehicle for twice-daily dosing.
According to a company press release, 47% of patients receiving 1.2 mg/mL of OC-01, 44% of patients receiving 0.6 mg/mL of OC-01 and 26% of control participants experienced at least a 10 mm change in Schirmer’s score at week 4, which was a statistically significant difference between both spray groups and control (P < .0001).
The OC-01 spray is similar to the TrueTear device, in that both use neurostimulation to produce a normal, optimal human tear, Mah said. Allergan has stopped production of the TrueTear device.
“With the TrueTear device, you had to place it almost perfectly in the nose,” Mah said. “Some people never found the perfect spot to stimulate the nerve fibers, but almost everyone has used a nasal spray. There isn’t much education needed for a nasal spray.”
The average increases in Schirmer’s scores were 11 mm in the 0.6 mg/mL group, 11.2 mm in the 1.2 mg/mL group and 5.9 mm in the control group. The study met its secondary endpoint of improvement in eye dryness score in the 1.2 mg/mL group at week 2 (P = .009) and week 4 (P = .002).
No serious adverse events were observed, and 99.9% of adverse events were mild. Participants reported no ocular burning or stinging with the spray.
The company reported it will submit a new drug application to the FDA this year.
“This could potentially be more readily accepted by patients who don’t want to go on a medication. It remains to be seen if this will be perceived in the same boat as the eye drop medications, but the more solutions we have to ocular surface disease and dry eyes, the better,” Mah said.
- Oyster Point Pharma ONSET-2 phase 3 study results and first quarter 2020 earnings conference call. investors.oysterpointrx.com/events/event-details/oyster-point-pharma-first-quarter-2020-earnings-conference-call. Published May 11, 2020. Accessed Aug. 11, 2020.
- Oyster Point Pharma meets primary endpoint in dry eye nasal spray study. www.healio.com/news/ophthalmology/20200512/oyster-point-pharma-meets-primary-endpoint-in-dry-eye-nasal-spray-study. Published May 12, 2020. Accessed Aug. 11, 2020.
- TrueTear. www.truetear.com. Accessed Aug. 20, 2020.
For more information:
- Francis S. Mah, MD, can be reached at Scripps Clinic, 10666 N. Torrey Pines Road, MS 214, La Jolla, CA 92037; email: email@example.com.