FDA Accepts Orasis Pharmaceuticals' New Drug Application for CSF-1 for the Treatment of Presbyopia

- Investigational, novel eye drop candidate was assigned PDUFA goal date of October 22, 2023

PONTE VEDRA, Fla., Feb. 21, 2023 /PRNewswire/ -- 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 the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for investigational CSF-1 (low dose pilocarpine hydrochloride 0.4%). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 22, 2023.

"We are encouraged by the acceptance of our NDA filing as we progress towards our mission of reshaping vision possibilities for the millions of people in the U.S. living with presbyopia, or blurry near vision," said Elad Kedar, Chief Executive Officer of Orasis Pharmaceuticals. "We look forward to working with the FDA towards approval and commercial launch of CSF-1."

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.

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. 

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SOURCE Orasis Pharmaceuticals