– Presbyopia is the loss of ability to focus on near objects as a result of the natural aging
process and affects more than 120 million people in the U.S.
– Phase 3 NEAR-1 and NEAR-2 clinical trials, involving over 600 patients, met primary
and key secondary endpoints and serve as the basis for the submission.
Ponte Vedra, FL, January 3, 2023 – Orasis Pharmaceuticals, an emerging ophthalmic
pharmaceutical company focused on developing a unique eye drop to improve near
vision for people with presbyopia, today announced that it has submitted a New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA) for investigational
CSF-1 (low dose pilocarpine hydrochloride 0.4%).
“This NDA submission is a significant milestone for Orasis as we advance CSF-1
towards commercialization and achieving our goal of reshaping vision possibilities for
patients,” said Elad Kedar, Chief Executive Officer of Orasis Pharmaceuticals. “With
more than 120 million people in the U.S. 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.”
The NDA is based on data from the Phase 3 NEAR-1 and NEAR-2 clinical trials,
involving more than 600 patients, which evaluated the efficacy and safety of CSF-1.
Both trials met their primary and key secondary endpoints on Day 8, achieving
statistically significant 3-line or more gain in distance-corrected near visual acuity
(DCNVA), and no loss of 1-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.
The Phase 3 NEAR-1 and NEAR-2 top-line results were previously announced earlier
this year, and additional details of these studies will be presented at future medical
meetings.
About CSF-1
CSF-1 is a novel corrective eye drop candidate being investigated for the treatment of
presbyopia. CSF-1 is a proprietary, preservative-free formulation of low-dose
pilocarpine and multi-faceted vehicle designed to achieve an optimal balance between
efficacy, safety and comfort. CSF-1 improves near visual acuity by pupil modulation,
resulting in a “pinhole effect” and an increase in the depth of field, thus increasing the
ability to focus on near objects.
About Presbyopia
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. There are almost two billion people globally and
more than 120 million people in the U.S. living with presbyopia. People with presbyopia
experience blurred vision when performing daily tasks that require near visual acuity,
such as reading a book, a restaurant menu, or messages on a smartphone. Presbyopia
cannot be prevented or reversed, and it continues to progress gradually. Many existing
treatment options can be either cumbersome or invasive, presenting a significant unmet
need for quality-of-life improvement for people with presbyopia.
About Orasis Pharmaceuticals
Orasis Pharmaceuticals is developing CSF-1, a corrective eye drop for the treatment of
presbyopia. Orasis is led by a collaborative team of industry executives and eye care
specialists with a broad range of experiences in research, development, and
commercialization of pharmaceutical drugs, as well as finance and business
development. Orasis is funded by a diverse group of sophisticated and experienced life
science and healthcare investors including the ophthalmology focused venture capital
fund Visionary Ventures, Sequoia Capital, SBI (Japan) Innovation Fund, Bluestem
Capital, LifeSci Venture Partners, Maverick Ventures Israel, and other private investors.
Orasis has offices in the U.S. and Israel. For more information, visit www.orasis-pharma.com and connect with us on LinkedIn.
Media Contact:
Amy Phillips
aphillips@greenroompr.com
412-327-9499