---
title: Orasis Pharmaceuticals Submits New Drug Application for Investigational Novel Eye Drop Candidate, CSF-1, for the Treatment of Presbyopia
description: 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
---

[Press Releases | Orasis Pharmaceuticals ](https://orasis-pharma.com/press-releases)

# [Orasis Pharmaceuticals Submits New Drug Application for Investigational Novel Eye Drop Candidate, CSF-1, for the Treatment of Presbyopia](https://orasis-pharma.com/press-releases/orasis-pharmaceuticals-submits-new-drug-application-for-investigational-novel-eye-drop-candidate-csf-1-for-the-treatment-of-presbyopia)

 Written by [Orasis Pharmaceuticals](https://orasis-pharma.com/press-releases/author/orasis-pharmaceuticals) | Jan 3, 2023 5:49:28 AM

– 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](https://www.orasis-pharma.com/orasis-pharmaceuticals-announces-positive-phase-3-topline-results-of-novel-eye-drop-candidate-csf-1-for-the-treatment-of-presbyopia/) 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](https://www.orasis-pharma.com/)                          and connect with us on [LinkedIn](https://www.linkedin.com/company/orasis-pharmaceuticals/).

**Media Contact:**

Amy Phillips  
 aphillips@greenroompr.com  
 412-327-9499

[View full post](https://orasis-pharma.com/press-releases/orasis-pharmaceuticals-submits-new-drug-application-for-investigational-novel-eye-drop-candidate-csf-1-for-the-treatment-of-presbyopia)

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