Oyster Point's nasal spray meets in Phase IIb for dry eye

Oyster Point Pharma Inc. (Princeton, N.J.) said its OC-02 nasal spray met the primary endpoints in the U.S. Phase IIb PEARL trial to treat dry eye disease. CEO Jeffrey Nau told BioCentury Oyster Point plans to begin a Phase III trial in 3Q19, with an NDA submission slated for 2020.

A potential first-in-class treatment, OC-02 is a nicotinic acetylcholine receptor (nAChR) agonist that stimulates the trigeminal nerve, accessible within the nose, to promote natural tear film production.

In the 165-patient trial, all three doses of OC-02 significantly improved tear production compared with vehicle control as evidenced by mean changes in Schirmer’s score of 8.6 mm (p=0.0018) at the 0.2% OC-02 dose, 17.1 mm (p<0.0001) at the 1% OC-02 dose and 19.3 mm (p<0.0001) at the 2% OC-02 dose vs. 2.6 mm for vehicle.

Mid- and high-dose OC-02 also significantly reduced symptoms as evidenced by mean reductions in Eye Dryness Scale (EDS) score of 16.5 mm (p=0.0067) and 19 mm (p=0.0006), respectively, vs. 6.8 mm for vehicle. Low-dose OC-02 missed that endpoint (mean reduction of 10.2 mm, p=0.46).

There were no reports of ocular adverse events or treatment-related serious adverse events.

Data are to be presented on July 15 at the American-European Congress of Ophthalmic Surgery in Deer Valley, Utah.

Oyster Point also has another nAChR agonist nasal spray in Phase II testing for dry eye disease, OC-01, which Nau said has a slightly different binding profile than OC-02. Nau said the company expects to report Phase II data for OC-01 in the next 12 months.

In November, Oyster Point raised $22 million in a series A led by Enterprise Associates and Versant Ventures (see “NEA, Versant Back Ophthalmic Play Oyster Point with 22M A Round”).