If approved, Orasis’ low-dose pilocarpine would be the second product that improves presbyopia, which is the age-related loss of clear up-close vision. The company plans to submit an NDA in the second half of the year.
Allergan’s Vuity (pilocarpine) eye drops for blurry vision may have soon have a competitor.
Orasis Pharmaceuticals expects to submit a new drug application to the FDA in the second half of 2022 for a lower dose version of pilocarpine that has shown in trials to last two hours longer. The company has released top-line data from two phase 3 studies showing that the therapy, for now called CSF-1, met both primary and secondary endpoints for improving presbyopia, age-related blurry vision.
Before Vuity’s approval last year, blurry vision was treated with glasses or surgery.
Pooled across the two studies of CSF-1, 40% and 50% of patients had improvement in their vision one hour after dose 1 and one hour after dose 2. CSF-1 started to work as early as 20 minutes and the benefit lasted up to 8 hours after dose 1.
The most common side effects were head headache and site pain. Of all CSF-1 participants, only 2.6% reported moderate side effects. All others were mild.
These results were achieved with a dose of pilocarpine that is one-third the concentration of Vuity. CSF-1 works by improving near visual acuity through pupil modulation, resulting in a “pinhole effect” and an increase in the depth of field, increasing the ability to focus on near objects.
The phase 3 data will form the basis of the company’s new drug application. Full results of these trials are expected to be released closer to the annual meeting of the American Academy of Ophthalmology, Sept. 30, 2022, to Oct. 3, 2022, according to a company spokesperson.
Phase 2b data were presented at the annual meeting of the 2022 American Society for Cataract and Refractive Surgery held in Washington, D.C., April 22, 2022, to April 26, 2022.
Two presentations showed that CSF-1 met the primary endpoints and achieved statistically significant improvements in distance-corrected near visual acuity (DCNVA) for participants with presbyopia. In the first presentation, 47% of participants in the CSF-1 group achieved a three-line or more gain in DCNVA one hour after treatment on day 15. The most common reported treatment-related adverse events experienced by more than 5% of trial participants included instillation site pain, headache, and vision blur.
“We’re also encouraged that there waso negative impact on distance or night vision, which is critical when looking at the potential benefit of an investigative treatment like CSF-1 could bring to patients to help them manage in their day-to-day lives,” Marjan Farid, M.D., an ophthalmologist with UCI Health in Orange, Calif., and presenting author, said in a press release.
In the second presentation, a post hoc analysis of the phase 2b trial were presented. The analysis met its primary endpoint of sustained improvement, with 47% of participants showing an improvement of 20/40 visual acuity level or better consistently over an eight-hour period on day 15 following one dose of CSF-1.
Presbyopia is the loss of ability to focus on near objects as a result of age. It occurs mostly after the age of 40 when the crystalline lens of the eye gradually stiffens and loses flexibility. There are almost two billion people globally and more than 120 million people in the United States living with presbyopia.
The first therapy to treat presbyopia was approved by the FDA in October 2021. Vuity (pilocarpine) is the only FDA-approved eye drop to treat this blurry age-related blurry vision, nearly half of the U.S. adult population. Vuity was developed by Allergan, an AbbVie company.
Vuity is a daily, prescription eye drop that works that lasts up to six hours. It uses the eye’s own ability to reduce pupil size, improving near vision without affecting distance vision.
The FDA approval is based on data from two pivotal phase 3 clinical studies, GEMINI 1 and GEMINI 2. In both studies, Vuity met the primary endpoint of improvement in near vision in low light conditions without a loss of distance vision on day 30 at hour three. There were no serious adverse events in either study. The most common adverse events occurring were headache and eye redness.