Orasis Pharmaceuticals Announces First Positive Phase 3 Results of Novel Eye Drop Candidate, CSF-1, for the Treatment of Presbyopia
– NEAR-1 and NEAR-2 Phase 3 clinical trials met key primary and secondary endpoints
– Presbyopia is the loss of the ability to focus on near objects due to the natural aging process and affects more than 120 million people in the United States
– Data from these trials (N=613) will serve as the basis for regulatory submission in the United States in the second half of 2022
PONTE VEDRA, Florida., April 21, 2022 /PRNewswire/ — Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on developing a unique eye drop to improve near vision in people with presbyopia, today announced that Phase 3 clinical trials of NEAR-1 and NEAR-2, which evaluated the efficacy and safety of CSF-1, its new eye drop candidate, met its primary and secondary endpoints. Additional details of these trials will be presented at future medical meetings and will form the basis for the submission of the New Drug Application to the United States Food and Drug Administration (FDA) in the second half of 2022.
In both trials, CSF-1 met its primary and secondary endpoints on Day 8, achieving a statistically significant gain of at least 3 lines of distance-corrected near visual acuity (DCNAV) and no loss of at least 1 line of distance visual acuity. acuity. Combined in the two studies, 40% and 50% of participants demonstrated these gains 1 hour after dose 1 and 1 hour after dose 2 respectively (P
These results were obtained with a minimum effective dose of 0.4% pilocarpine hydrochloride, which is less than one-third the concentration of the commercially available treatment. With a proprietary vehicle, CSF-1 is formulated without preservatives and offers dosing flexibility with a comfort and safety profile that does not compromise distance or night vision.
“Currently, optometry provides 85% of all comprehensive eye care exams, making a difference in the vision of so many patients,” said Paul Karpecki, OD, FAAO. “New and existing presbyopic patients will enter an optometry practice which now offers presbyopic drops, as well as contact lenses and glasses – all playing a part in managing patients looking for options.”
“These statistically significant and clinically meaningful results are promising as eye care providers are eager to find other treatment options to improve the quality of life of their patients with presbyopia, many of whom rely solely on reading glasses, which can be cumbersome,” said Edward HollandMD, professor of ophthalmology, University of Cincinnati and Director of Cornea, Cincinnati Eye Institute. “Based on demonstrated efficacy and excellent tolerability with such a minimal effective dose, I would consider CSF-1 a clear place to start for many presbyopic patients.”
“We are extremely pleased with these positive results, which mark an important milestone for CSF-1 and Orasis, and position us well to be the next product to launch in this exciting category,” said Elad Kedar, CEO of Orasis Pharmaceuticals. “The potential for CSF-1 to provide a first-line treatment option for people with presbyopia is promising and we look forward to working with regulatory authorities to advance CSF-1 towards commercialization.”
In order to provide strategic options for CSF-1, Orasis plans to initiate a safety study with the possibility of a long-term extension.
The Phase 3, multi-center, double-blind, parallel-group clinical studies NEAR-1 and NEAR-2 enrolled 613 participants aged 45 to 64 in the United States with presbyopia to further evaluate the efficacy and safety of CSF-1. Participants were randomized in a one-to-one ratio between vehicle (placebo) and CSF-1 (0.4% pilocarpine hydrochloride). CSF-1 was administered twice daily for two weeks with four study visits: screening, days 1 (baseline), 8, and 15. Primary endpoints were defined as the percentage of participants with a gain of 3 or more lines in mesopic, distance-corrected near visual acuity (DCNVA), 1 hour after dose 1 on day 8. Primary secondary endpoints were defined as the percentage of participants with a gain of 3 lines or more in DCNVA and no loss of 1 line or more in distance visual acuity at 2 hours after dose 1, 1 hour after dose 2 and 2 hours after dose 2 on day 8.
CSF-1 is a new corrective eye drop candidate under study for the treatment of presbyopia. CSF-1 is a proprietary, preservative-free formulation of low-dose pilocarpine and a multi-faceted vehicle designed to achieve an optimal balance of efficacy, safety and comfort. CSF-1 improves near visual acuity through pupil modulation, resulting in a “pinhole effect” and increased depth of field, increasing the ability to focus on nearby objects.
Presbyopia is the loss of ability to focus on near objects due to the natural aging process. It mainly occurs after the age of 40 when the lens of the eye gradually stiffens and loses its flexibility. Nearly two billion people worldwide and more than 120 million people in the United States live with presbyopia. People with presbyopia have blurred vision when performing everyday tasks that require near visual acuity, such as reading a book, a restaurant menu, or texting on a smartphone. Presbyopia cannot be prevented or reversed, and it continues to progress gradually. Many existing treatment options can be cumbersome or invasive, presenting a significant unmet need to improve the quality of life for people with presbyopia.
About Orasis Pharmaceuticals
Orasis Pharmaceuticals is developing CSF-1, a corrective eye drop for the treatment of presbyopia as an alternative to reading glasses. By repurposing existing and well-studied molecules, CSF-1 is designed to be effective, safe, comfortable and easy to use. Orasis is led by a collaborative team of industry leaders and eye care specialists with a wide range of experience in pharmaceutical drug research, development and commercialization, as well as finance and business development. Orasis is funded by a diverse group of sophisticated and experienced life sciences and healthcare investors, including visionary ventures ophthalmology-focused venture capital fund Sequoia Capital, SBI (Japan) Innovation Fund, Bluestem Capital, LifeSci Venture Partners, Maverick Ventures Israel and other private investors. Orasis has offices in the United States and Israel. For more information, visit www.orasis-pharma.com and join us on LinkedIn: LinkedIn.