Oyster Point Pharma’s dry eye disease treatment met both sign and symptom primary endpoints in a phase 2b clinical trial, the company announced in a press release.
OC-02, a nicotinic acetylcholine receptor agonist, is delivered as a nasal spray and stimulates the trigeminal parasympathetic pathway to activate the glands that produce the eye’s natural tear film, the release said.
A total of 165 patients with dry eye disease were evaluated in the dose-ranging, randomized, double-masked, vehicle-controlled PEARL study.
Patients who received the 2% dose had a mean change in Schirmer’s score of 19.3 mm, whereas those who received the 1% dose had a mean change of 17.1 mm and those in the 0.2% dose group had a mean change of 8.6 mm, according to the release. All of these changes were statistically significant when compared with the control arm, which had a mean change of 2.6 mm.
In addition, OC-02 showed a statistically significant reduction in symptoms — measured by a reduction in Eye Dryness Scale (EDS) score — in the two highest dose groups. The 2% group had an EDS score change of –19 mm and the 1% group had a mean change of –16.5 mm. The 0.2% group had a mean change of –10.2 mm, while the control arm had a mean change of –6.8 mm.
“Showing a statistically significant improvement in both the signs and symptoms of dry eye within the same clinical trial validates the potential of stimulating the trigeminal parasympathetic pathway with this class of compound to increase natural tear film production,” Oyster Point CEO Jeffrey Nau, PhD, said in the release. “These results indicate a clear dose-response to OC-02 and suggests that this novel approach can stimulate tear production in dry eye patients with a broad range of baseline severity.”