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.
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.