Aerie Pharmaceuticals, Inc. (AERI) stock plummeted 17.83% in the after-hours trading session at the price of $12.90 after the announcement of positive topline findings of its Phase 2b clinical study, named COMET-1, for AR-15512. AERI is an ophthalmic pharmaceutical company. It discovers, develops, and commercializes therapies to treat eye diseases related to open-angle glaucoma and other retinal diseases.
Statistical Significance of Novel Dry Eye Product Candidate, AR-15512 (TRPM8 Agonist)
On 15th September 2021, AERI published positive results of its Phase 2b clinical study for AR-15512 ophthalmic solution to treat patients with dry eye disease. The conference call will host by the management to discuss the relevant results at 5:00 p.m. ET. This Phase 2b clinical study evaluated the efficacy and safety of AR-15512. The randomized, double-masked, vehicle-controlled study was conducted at 15 sites in the United States. About 369 patients randomized across three arms, AR-15512, AR-15512, and AR-15512 vehicle. The patients of each category dosed twice daily for about 84 days and evaluated on days 1, 14, 28, and 84.
CEO of AERI, Vicente Anido, remarked that they are excited to achieve significant improvements on multiple FDA-recognized symptoms in their COMET-1 Phase 2b clinical study. The number of symptom endpoints demonstrated the importance of this drug for patients with dry eye diseases. The company believes that they have a clear path toward approval of their AR-15512. They expect to end the Phase 2 meeting with the Food and Drug Administration by the first quarter of 2022. They are also working to conduct two additional three-month Phase 3 efficacy studies and an additional safety study, he added.
Appointment of Carolyn McAuliffe as Senior Director of Communications
On 13th September 2021, AERI announced that the company had appointed Carolyn McAuliffe as their Senior Director of Communications. Ms. McAuliffe will develop and execute activities related to Aerie’s marketing and medical communications. She most recently worked in the relevant position at Masimo Corporation. Additionally, she will acquire awards totaling 16,900 stock options that will vest over four years.
AERI Appointed Michael Bradley as Senior Director of Manufacturing
On 7th September 2021, AERI published the appointment of Michael Bradley as their Senior Director of Manufacturing. Mr. Bradley will report to the Site Director at Athlone. His duties include manufacturing and supply chain operations at Aerie’s manufacturing facility in Athlone. He will get awards totaling 16,900 stock options that will vest over four years.
