Orasis Pharmaceuticals Announces CSF-1 Eye Drop Successfully Met Primary Endpoint in Phase 2b Clinical Study in Presbyopia
10/10/2019 | 09:31am EDT
HERZLIYA, Israel, Oct. 10, 2019 (GLOBE NEWSWIRE) -- Orasis Pharmaceuticals LTD., a clinical stage pharmaceutical company developing a corrective eye drop for the treatment of presbyopia as an alternative to reading glasses, today announced its CSF-1 eye drop has successfully met the primary endpoint in a Phase 2b clinical study in individuals with presbyopia.
CSF-1 successfully demonstrated statistically significant improvement in distance-corrected near visual acuity of a 3-line or greater gain. In addition, CSF-1 demonstrated an exceptional safety and tolerability profile. Full results from the study will be submitted for presentation at an upcoming medical meeting.
“The successful completion of the Phase 2b study is a significant milestone for Orasis. We are encouraged by these results and CSF-1’s potential to improve the quality of life for people with presbyopia,” said Elad Kedar, chief executive officer of Orasis. “CSF-1 can potentially alleviate the burden of reading glasses and offer a meaningful solution for billions of people living with age-related farsightedness worldwide.”
“We are pleased with CSF-1’s clinical performance in our Phase 2b study, as demonstrated by the positive efficacy, safety and tolerability results,” said Ron Neumann, M.D., chief medical officer of Orasis, “We look forward to presenting additional details at an upcoming ophthalmology meeting. In the meantime, we are moving forward as quickly as possible with our preparation for Phase 3.”
The Phase 2b study (NCT03885011) was a multi-center, double-masked clinical trial that evaluated the efficacy and safety of CSF-1 in 166 participants across several research centers in the U.S. For more details about the study, please visit ClinicalTrial.gov.
Presbyopia is the inability to focus on near objects. It commonly occurs after the age of 40 and affects more than 1.8 billion people worldwide. 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 occurs as a result of the natural aging process when the crystalline lens of the eye gradually stiffens and loses flexibility. Presbyopia cannot be prevented or reversed, and it continues to progress gradually. All existing treatment options are 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 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 executives and ophthalmologists with a diverse set 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, LifeSci Venture Partners, Maverick Ventures Israel, and other private investors. Orasis is based in Herzliya, Israel. For more information, visit www.orasis-pharma.com.