Phase 2b trials of Orasis Pharmaceuticals’ presbyopia treatment, CSF-1 (0.4% pilocarpine HCl) showed 80% patients achieved a two-line improvement in near vision, comparable to achieving 20/40 or better Snellen functional near visual acuity.
Presenting the results at the American Society of Cataract and Refractive Surgery conference, Dr Preeya Gupta, from Triangle Eye Consultants in North Carolina, US, said CSF-1 maintained this near vision improvement from 20 minutes to eight hours after instillation. The study also achieved its primary endpoint, with 47% of participants in the CSF-1 group achieving a three-line or more gain in distance-corrected near visual acuity one-hour post-treatment on day 15, compared with 16% in the control group (p=0.0002). CSF-1 also demonstrated tolerability with a favourable safety profile, she reported.
“In addition to meeting the primary endpoint, achieving the secondary endpoint of a two-line or more gain is clinically meaningful, especially for early presbyopes whose near vision is not yet severely impacted,” said co-author Professor Marjan Farid from the University of California. “We’re also encouraged that there was no negative impact on distance or night vision, which is critical when looking at the potential benefit an investigative treatment like CSF-1 could bring to patients to help them manage in their day-to-day lives.”
