FDA Sets Goal Date for Blurry Vision Therapy

The FDA has accepted for review Orasis Pharmaceuticals’ new drug application (NDA) for CSF-1 to treat people with presbyopia, or age-related blurry vision. CSF-1 is a preservative-free formulation of low-dose pilocarpine administered as an eye drop. The agency has assigned a Prescription Drug User Fee Act (PDUFA) goal date of Oct. 22, 2023.

Presbyopia is the loss of ability to focus on near objects as a result of the natural aging process. It occurs mostly after the age of 40 when the crystalline lens of the eye gradually stiffens and loses flexibility. Almost 2 billion people globally and more than 120 million people in the United States live with presbyopia.

Related: Therapy for Blurry Vision Shows Positive Results

The application is based on data from the phase 3 NEAR-1 and NEAR-2 clinical trials, involving more than 600 patients. Both trials met their primary and key secondary endpoints on day 8, achieving statistically significant three-line or more gain in distance-corrected near visual acuity (DCNVA), and no loss of one-line or more in distance visual acuity. Pooled across the two studies, 40% and 50% of participants demonstrated these gains one hour after dose 1 and one hour after dose 2, respectively. It started to work as early as 20 minutes and the benefit lasted up to 8 hours after dose 1.

The most common treatment-related adverse events of headache and instillation site pain occurred in only 6.8% and 5.8% of participants, respectively. Of all CSF-1 participants, only 2.6% reported moderate treatment-related adverse events. All other adverse events were mild.

If approved, CSF-1 will compete with Vuity, which was the first therapy to treat presbyopia approved by the FDA in October 2021. Vuity was developed by Allergan, an AbbVie company. Vuity is a daily, prescription eye drop that works lasts up to 6 hours. Vuity uses a technology allows the therapy to rapidly adjust to the physiologic pH of the tear film. It uses the eye’s own ability to reduce pupil size, improving near vision without affecting distance vision.