Orasis Pharmaceuticals Announces Phase 2b Efficacy and Safety Trial Results of Novel Eye Drop Candidate for Presbyopia, CSF-1, at the 2022 Annual Meeting of the American Society of Cataract and Refractive Surgery (ASCRS) )

– Two presentations on the Phase 2b Clinical Trial Shows CSF-1 Met Primary Endpoints and Achieved Statistically Significant and Clinically Meaningful Improvements in Distance Corrected Near Visual Acuity (DCNVA) for Participants with Presbyopia

– 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

BRIDGE VEDRAFlorida. , April 23, 2022 /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 Phase 2b data demonstrating the efficacy and safety of its new eye drop candidate, CSF-1, for the treatment of presbyopia at the 2022 American Society for Cataract and Refractive Surgery (ASCRS) Annual Meeting taking place from May 22 to April 26 in Washington, D.C. 2b served as the basis for the design and conduct of the NEAR-1 and NEAR-2 Phase 3 clinical trials of CSF-1, for which initial results have been recently announced.

During the first communication session, which will be presented on Monday April 25the sentence 2b trial results showed that CSF-1 preservative-free ophthalmic solution (0.4% pilocarpine hydrochloride) formulated in a proprietary vehicle met its primary endpoint, 47% of participants in the CSF-1 group achieving a gain of 3 or more lines in DCNVA 1 1-hour post-treatment on day 15, compared to 16% in the vehicle group (P=0.0002). Additionally, the trial met its secondary endpoint, with 80% of participants in the CSF-1 group achieving a gain of 2 or more DCNVA lines, compared to 43% in the vehicle group (P=0.0001). CSF-1 demonstrated tolerance with a favorable safety profile. The most reported treatment-related adverse events experienced by more than 5% of trial participants included instillation site pain (5.5%), headache (9.1%), and vision (10.9%). All study adverse events were reported as mild, transient, and self-resolving.

“In addition to achieving the primary endpoint, achieving the secondary endpoint of a gain of 2 or more lines is clinically significant, particularly for early presbyopes whose near vision is not still badly affected,” said Marjan Farid, MD, Presenting Author. “We are also encouraged that there was no negative impact on distance or night vision, which is critical when considering the potential benefit of an investigational treatment like CSF. -1 could bring to patients to help them manage their daily lives.”

In addition, a post hoc analysis of Phase 2b trial of CSF-1 will be presented during the second communication session on Monday April 25. The scan met its primary endpoint of sustained improvement, with 47% of participants showing improvement in visual acuity (VA) level of 20/40 or better consistently over an 8-hour daytime period 15 after one dose of CSF-1. In monocular and binocular measures, the proportion of participants who achieved sustained improvements in DCNVA was higher in the CSF-1 group compared to vehicle for participants assessed for sustained 20/40 vision at all time points (P

“These results, which showed that a greater proportion of participants receiving CSF-1 achieved sustained functional near vision of 20/40 or better versus vehicle when tested binocularly, demonstrate a clinically meaningful improvement. which may make it easier for people treated with CSF-1 to carry out daily activities that require near vision,” said Preeya K. GuptaMD, presenting author.

Binocular summation, or the superiority of binocular performance over monocular performance, is strongly implicated in improving visual acuity.1,2,3 As binocular suppression is seen in a majority of presbyopic patients,4 achieving binocular summation is an important marker for assessing the effectiveness of potential treatments for this age-related condition.

“We are pleased with the favorable safety and efficacy results of this study, as well as the rapid onset and sustained duration of action,” said Elad Kedar, Chairman and CEO of Orasis Pharmaceuticals. “The sentence 2b provided strong data and critical direction to inform the NEAR-1 and NEAR-2 Phase 3 clinical trials, for which we recently reported similar positive efficacy and safety results. The consistency of these results, which had nearly identical designs, reinforces the efficacy, safety and comfort of CSF-1, and its potential to provide a first-line treatment option for people living with presbyopia. »

* ASCRS Disclaimer: All educational content for the ASCRS Annual Meeting is planned by its program committee, and ASCRS does not endorse, promote, endorse or recommend the use of any product, device or service.

About CSF-1

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 by modulation of the pupil, resulting in a “pinhole effect” and increased depth of field, thereby increasing the ability to focus on near objects.

About presbyopia

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.

References


1 Pineles SL, et al. JAMA. 2013;131(11):1413-1419.
2 Blake R, et al. Perception Psychophysis. 1981;30(3):266-276.
3 Cagenello R, et al. J Opt Soc Am A Opt Image Sci Vis. 1993. 10(8):1841-1848.
4 Rozanova O, et al. Eye and Vision. 2018;5:1. DOI 10.1186/s40662-018-0095-0.

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SOURCEOrasis Pharmaceuticals

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