Orasis Pharmaceuticals Announces Phase 2b Trial Efficacy and Safety Results of Novel Presbyopia Eye

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

- Two presentations on the Phase 2b clinical trial show CSF-1 met the 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 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.

PONTE VEDRA, Fla. , 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 novel eye drop candidate, CSF-1, for the treatment of presbyopia at the 2022 American Society for Cataract and Refractive Surgery (ASCRS) Annual Meeting being held April 22-26 in Washington, D.C. The Phase 2b trial served as the foundation for the design and conduct of the Phase 3 NEAR-1 and NEAR-2 clinical trials of CSF-1, for which topline results were recently announced.

In the first Paper Session, which will be presented on Monday, April 25, the Phase 2b trial results showed that CSF-1 (pilocarpine hydrochloride 0.4%) preservative-free ophthalmic solution formulated in a proprietary vehicle met its primary endpoint, with 47% of participants in the CSF-1 group achieving a 3-line or more gain in DCNVA 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 2-line or more gain in DCNVA compared to 43% in the vehicle group (P=0.0001). CSF-1 demonstrated tolerability with a favorable safety profile. The most reported treatment-related adverse events experienced by over 5% of trial participants included instillation site pain (5.5%), headache (9.1%) and vision blur (10.9%) with all adverse events in the study reported as mild, transient and self-resolving.

"In addition to meeting the primary endpoint, achieving the secondary endpoint of a 2-line or more gain is clinically meaningful, especially for early presbyopes whose near vision is not yet severely impacted," said Marjan Farid, M.D., presenting author. "We're also encouraged that there was no negative impact on distance or night vision, which is critical when looking at the potential benefit of an investigative treatment like CSF-1 could bring to patients to help them manage in their day-to-day lives."

Additionally, a post hoc analysis of the Phase 2b trial of CSF-1 will be presented in the second Paper Session on Monday, April 25. The analysis met its primary endpoint of sustained improvement, with 47% of participants showing an improvement of 20/40 visual acuity (VA) level or better consistently over an 8-hour period on Day 15 following one dose of CSF-1. In both monocular and binocular measurements, the proportion of participants who achieved sustained DCNVA improvements was higher in the CSF-1 group vs. vehicle for participants assessed for sustained 20/40 vision across all time points (P<0.05).

"These results, which showed that a greater proportion of participants receiving CSF-1 achieved sustained functional near vision of 20/40 or better compared to vehicle when tested binocularly, demonstrate clinically meaningful improvement that may allow individuals treated with CSF-1 to more easily conduct day-to-day activities requiring near vision," said Preeya K. Gupta, M.D., presenting author.

Binocular summation, or the superiority of binocular performance over monocular performance, is acutely involved with improved visual acuity.^1,2,3 As binocular suppression is observed in a majority of patients with presbyopia,⁴ achieving binocular summation is an important marker for evaluating efficacy of potential treatments for this age-related condition.

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

*ASCRS Disclaimer: All educational content of the ASCRS Annual Meeting is planned by its program committee, and ASCRS does not endorse, promote, approve, or recommend the use of any products, devices, or services.

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.

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.

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 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.  

References

¹ Pineles SL, et al. JAMA. 2013;131(11):1413-1419.

² Blake R, et al. Percep Psychophys. 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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