A Study of the Response to AG-86893 in Patients With Pterygium Hyperemia
Summary
A pterygium is a wing-shaped, benign tissue growth which forms on the surface of the conjunctiva and grows towards the cornea. It can eventually lead to vision impairment. The precise cause of pterygium formation is unknown but new blood vessel growth and fibroblastic structures are characteristics of the disease. AG-86893 is an eye drop being developed to treat hyperemia (redness) and growth of the pterygium. Hypothesis 1. AG-86893 dosed three times daily for 28 consecutive days has an acceptable safety profile as measured by the incidence and severity of adverse events (AEs) compared with vehicle 2. At least 1 concentration of AG-86893 is effective, as measured by the mean change from baseline in conjunctival hyperemia (redness), compared with vehicle
Timeline
- Start
- 2018-10-11
- Primary completion
- 2019-09-05
- Completion
- 2019-10-25
Outcome
Missed primary endpoint
registry analysis (superiority test); Vehicle Eye Drops vs 0.3% AG-86893 Eye Drops; p = 0.218; Mixed Models Analysis reads as missed primary endpoint NCT03533244 ↗
release “early topline results showed promising safety, tolerability, and signs of efficacy from its ongoing SURPH Phase 2a Study of AG-86893 in patients with Pterygium.” reads as unknown allgenesis.com ↗
release “final data analysis from its POC Phase 2a study of AG-86893 in patients with Pterygium reaffirmed the safety, tolerability, and signs of efficacy” reads as unknown allgenesis.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AG-86893 | Unknown | 0.1 % | Topical |
| Subject | AG-86893 | Unknown | 0.3 % | Topical |