August 31, 2022
1 min read
Wirta reports consulting for Aerie, Allergan, Eyenovia, Novartis, Oyster Point Pharma and Santen and receiving financial support from AbbVie, Aerie, Allergan, Allysta, Bausch + Lomb, Eyenovia, Jenivision, Nicox, Novaliq, Novartis, Ocuphire, Ora, Orasis, Osmotica, Oyster Point Pharma, Qlaris, Santen, Tarsus, TearCare and Visus.
AR-15512, a transient receptor potential melastatin 8 agonist, demonstrated significant improvement of dry eye disease signs, symptoms and related quality of life in a phase 2b study.
The potential benefits of targeting neuronal pathways as an alternative treatment option for dry eye were demonstrated in a previous phase 1/2a study that showed AR-15512 at 0.0014% concentration was safe and well tolerated and resulted in improved tear production, tear stability and dry eye disease (DED) symptoms.
The phase 2b randomized, vehicle-controlled, multicenter clinical study was designed to better characterize the safety and efficacy of AR-15512 in DED at a higher concentration and over a longer follow-up time. Three hundred sixty-nine subjects were randomly assigned 1:1:1 to receive two different topical AR-15512 concentrations (0.0014% or 0.003%) or vehicle twice a day for 12 weeks in both eyes; 72% of subjects were women, and the mean age of the subjects was 63.7 years.
AR-15512 0.003% consistently demonstrated superior efficacy to vehicle in DED signs and symptoms. Tear production, measured by Schirmer test, was significantly increased with both concentrations after a single drop on day 1, and the effect was sustained over time with regular dosing. A statistically significant increase in tear meniscus height was observed on OCT with the 0.003% concentration. Significant reduction of DED symptoms was reported by patients in questionnaires, showing progressive differentiation from vehicle from day 14 to day 84 with 0.003% AR-15512. Relief from symptoms resulted in significant quality of life improvement. Most ocular side effects were rated as mild in severity.
“These results support further clinical development of 0.003% AR-15512 as a novel treatment for signs and symptoms of DED,” the authors wrote.