Positive results were announced from two phase 3 trials evaluating the efficacy and safety of CSF-1, a novel corrective eye drop candidate, for the treatment of presbyopia in adults.
CSF-1 is a preservative-free solution that contains a proprietary combination of low-dose pilocarpine hydrochloride 0.4% and multifaceted vehicle. The investigational drug is designed to improve near vision in patients with presbyopia without compromising distance or night vision.
The multicenter, double-masked, vehicle-controlled NEAR-1 (ClinicalTrials.gov Identifier: NCT04599933) and NEAR-2 (ClinicalTrials.gov Identifier: NCT04599972) trials included 613 patients aged 45 to 64 years with presbyopia. Patients were randomly assigned 1:1 to receive 1 drop bilaterally twice daily of either CSF-1 or placebo for approximately 2 weeks.
Findings from both trials showed that treatment with CSF-1 met the primary and key secondary endpoints demonstrating a statistically significant 3-line or more gain in distance-corrected near visual acuity (DNCVA) on day 8, and no loss of 1-line or more in distance visual acuity. Pooled data showed that 40% and 50% of patients treated with CSF-1 had these gains 1 hour post dose 1 and 1 hour post dose 2, respectively (P <.0001).
Additionally, a statistically significant 3-line improvement was observed in patients treated with CSF-1 at all measured time points on days 1 and 15. On day 15, a statistically significant 3-line improvement in DCNVA was observed as early as 20 minutes and up to 8 hours post dose 1. The most common treatment-related adverse events for CSF-1 were headache (6.8%) and instillation sight pain (5.8%).
The Company expects to submit a New Drug Application to the Food and Drug Administration in the second half of 2022.