Orasis Pharmaceuticals Announces CSF-1 Meets Primary and Key Secondary Endpoints in Two Phase 3 Trials for Presbyopia

Today, Orasis Pharmaceuticals announced that its investigational eye drop therapy CSF-1 for improving near vision in patients with presbyopia met the primary endpoint and key secondary endpoints in two Phase 3 clinical trials. These trial results will form the basis for the company’s submission of a New Drug Application (NDA) to the U.S. FDA in the second half of this year.

Presbyopia Affects Nearly 2 Billion People Worldwide, Most Patients Can Only Choose to Wear Reading Glasses, But It Is Inconvenient for Patients. Last October, Vuity (Pilocarpine 1.25% Ophthalmic Solution) From Allergan, a Subsidiary of AbbVie, Was Approved by the U.S. FDA, Becoming the First Eye Drop Therapy Approved for the Treatment of Presbyopia.

Orasis Pharmaceuticals' CSF-1 is a preservative-free ophthalmic solution formulation composed of low-dose pilocarpine and multiple excipients, with a pilocarpine concentration of 0.4%. Its primary mechanism of action is pupil constriction, which enhances depth of field and improves near and intermediate vision.

In these two Phase 3 clinical trials, patients with presbyopia received CSF-1 treatment twice daily. The trial results showed that CSF-1 reached the primary and key secondary endpoints on Day 8 of the trial. The proportion of patients who could read three additional lines on the eye chart significantly increased. Within one hour after receiving the first dose, 40% of patients could read three additional lines, and this proportion reached 50% after the second dose (p<0.0001).

Moreover, CSF-1 significantly increased the proportion of patients who could read three additional lines on the eye chart on both Day 1 and Day 15 of treatment. Subjects experienced vision improvement as early as 20 minutes after receiving the treatment, with effects lasting up to 8 hours.

CSF-1 Demonstrates Good Tolerability and Safety Profile with Similar Redness and Comfort Metrics Compared to Vehicle. The most common adverse events were headache and instillation site pain, occurring in 6.8% and 5.8% of participants, respectively. Among all treated participants, only 2.6% reported moderate treatment-related adverse events, with the remainder being mild.

References:

[1] ORASIS PHARMACEUTICALS ANNOUNCES POSITIVE PHASE 3 TOPLINE RESULTS OF NOVEL EYE DROP CANDIDATE, CSF-1, FOR THE TREATMENT OF PRESBYOPIA. Retrieved April 21, 2022, from https://www.orasis-pharma.com/orasis-pharmaceuticals-announces-positive-phase-3-topline-results-of-novel-eye-drop-candidate-csf-1-for-the-treatment-of-presbyopia/

(The original text has been abridged)

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