Orasis Submits NDA for Blurry Vision Treatment

Orasis Pharmaceuticals has submitted a new drug application (NDA) to the FDA for investigational 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.

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.

If approved, this would be the second therapy to treat patients with presbyopia. The first FDA- approved therapy is Vuity, which 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. The wholesale acquisition cost (WAC), for one bottle of Vuity is $73.49

Elad Kedar

“With more than 120 million people in the United States affected, we look forward to working with the FDA during its review process to ultimately provide an alternative treatment option for patients seeking flexibility in managing their presbyopia,” Elad Kedar, chief executive officer of Orasis Pharmaceuticals, said in a press release.

Related: Therapy for Blurry Vision Shows Positive Results

The NDA 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.

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.