Signs, symptoms and quality of life improve with dry eye treatment in phase 2b study


August 31, 2022

1 minute read


Disclosures: Wirta declares to be a consultant for Aerie, Allergan, Eyenovia, Novartis, Oyster Point Pharma and Santen and to receive 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.

We have not been able to process your request. Please try again later. If you continue to have this problem, please contact

AR-15512, a potent transient melastatin 8 receptor agonist, demonstrated significant improvement in dry eye signs and symptoms and associated quality of life in a phase 2b study.

The potential benefits of targeting neural pathways as an alternative treatment option for dry eye have been demonstrated in a previous Phase 1/2a study which showed AR-15512 at a concentration of 0.0014% to be safe and well tolerated and resulted in improved tear production, tear stability and dry eye. symptoms of eye disease (EDD).


The randomized, vehicle-controlled, multicenter Phase 2b 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 period. Three hundred sixty-nine subjects were randomized 1:1:1 to receive two different concentrations of topical AR-15512 (0.0014% or 0.003%) or vehicle twice daily for 12 weeks in both eyes ; 72% of the 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 the signs and symptoms of DED. Tear production, measured by Schirmer’s test, was significantly increased with both concentrations after a single drop on day 1, and the effect was maintained over time with consistent dosing. A statistically significant increase in the height of the tear meniscus was observed on OCT with the concentration of 0.003%. A significant reduction in DED symptoms was reported by patients in questionnaires, showing progressive vehicle differentiation from day 14 to day 84 with 0.003% AR-15512. Symptom relief resulted in a significant improvement in quality of life. Most ocular side effects were classified as mild in severity.

“These results support the continued clinical development of 0.003% AR-15512 as a novel treatment for the signs and symptoms of DED,” the authors wrote.

Source link

Comments are closed.