Aerie Pharmaceuticals announced significant increases in tear production in the phase 2b study of its dry-eye disease (DED) drops AR-15512, which it says also create a cooling sensation on the eye.
Speaking to Modern Retina, Aerie vice president of clinical development and medical affairs, Dr Michelle Senchyna said the study’s 369 patients were randomised to two concentrations of the TRPM8 agonist, plus vehicle alone. The higher dose, 0.003%, demonstrated upwards of 20mm of wetting on an uninitialised Schirmer's test and showed significant quality of life improvements at 14 days, with statistically significant improvements in ocular discomfort and eye dryness at day 84. All formulations were safe and well-tolerated, said Dr Senchyna, with 95% of the ‘normal’ adverse effects being reported as mild by the subjects.
AR-15512 is an agonist molecule of transient receptor potential melastatin 8 (TRPM8), a cold receptor located in the eyelid and cornea. Aerie’s report on its phase 1/2a study of the drops said that TRPM8 nerve terminals detect drops in corneal temperature associated with evaporation from the ocular surface, with their dysfunction possibly playing a role in DED.
