Orasis Announces Results of Phase 2b and Phase 3 Results of CSF-1 Trials
Orasis Pharmaceuticals has announced results from its Phase 3 NEAR-1 and NEAR-2 clinical trials of the company’s presbyopia eye drop candidate CSF-1 (pilocarpine hydrochloride 0.4%), a preservative-free ophthalmic solution formulated in a proprietary vehicle, and says data from these trials will be the basis for regulatory submission in the U.S. in the second half of 2022. Both trials met 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. Pooled across the two studies, 40% and 50% of participants demonstrated these gains 1-hour post-dose 1 and 1-hour post-dose 2 respectively. CSF-1 also achieved statistically significant 3-line improvement at all measured time points on Days 1 and 15. In addition, CSF-1 demonstrated an excellent tolerability and safety profile, with comparable redness and comfort versus vehicle. Orasis also announced Phase 2b data that showed CSF-1 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. The trial also 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. CSF-1 demonstrated tolerability with a favorable safety profile. A post hoc analysis of the Phase 2b trial met its primary endpoint of sustained improvement, with 47% of participants showing an improvement of 20/40 visual acuity 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. More information can be found at https://www.prnewswire.com/news-releases/orasis-pharmaceuticals-announces-positive-phase-3-topline-results-of-novel-eye-drop-candidate-csf-1-for-the-treatment-of-presbyopia-301529894.html and https://www.prnewswire.com/news-releases/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-301530823.html.
Visus and Zhaoke Ophthalmology Announce Licensing Agreement
Visus Therapeutics and Zhaoke Ophthalmology Limited have announced an exclusive licensing agreement for the development and commercialization of BRIMOCHOL PF and Carbachol PF in Greater China, South Korea, and select Southeast Asian territories. BRIMOCHOL PF and Carbachol PF are investigational, preservative-free therapeutics designed to be long-acting, once-daily eye drops to correct for the loss of near vision associated with presbyopia. Under the terms of the agreement, Zhaoke will be responsible for clinical development and regulatory approval for BRIMOCHOL PF and Carbachol PF in the specified territories, and subsequently the commercialization activities for the products. Visus will receive an upfront payment of $15 million and will potentially receive up to $115 million in regulatory, commercialization and sales-driven milestones. Additionally, Visus will earn tiered royalties on future sales of these products in the contracted territories. Zhaoke will leverage the considerable clinical development experience and plans that Visus has implemented for its currently enrolling Phase 3 studies to fulfill the requisite clinical requirements and bring the products to market quickly. More information can be found at https://www.businesswire.com/news/home/20220511005170/en/Visus-Therapeutics-Inc.-and-Zhaoke-Ophthalmology-Limited-Announce-Exclusive-Licensing-Agreement-to-Commercialize-BRIMOCHOL%E2%84%A2-PF-and-Carbachol-PF-in-Greater-China-South-Korea-and-Select-Southeast-Asian-Markets-for-the-Treatment-of-Presbyopia.
Ocuphire Appoints Dr. Jay Pepose as Chief Medical Advisor
Ocuphire Pharma has announced the appointment of Jay Pepose, MD, PhD, as its chief medical advisor. Dr. Pepose has served on Ocuphire’s medical advisory board since 2018 and board of directors since 2021. Founder and CEO Mina Sooch, MBA, said Dr. Pepose’s appointment comes at a strategic time for the company, as it approaches important clinical and regulatory milestones including the initiation of the presbyopia Phase 3 program for both Nyxol and Nyxol with low-dose pilocarpine. Dr. Pepose is a specialist in refractive surgery and corneal and external diseases, and is the founder and medical director of the Pepose Vision Institute. He also founded the Midwest Corneal Research Foundation, now the Lifelong Vision Foundation; a non-profit organization focused on supporting research and education efforts in ophthalmology and providing vision treatment to underserved communities. He is a professor of clinical ophthalmology and visual sciences at Washington University School of Medicine in St. Louis and a consultant to the Centers for Disease Control and other large ophthalmic companies. More information can be found at https://www.ocuphire.com/news-media/press-releases/detail/369/ocuphire-appoints-jay-pepose-m-d-ph-d-as-chief-medical.
LENZ Therapeutics and Ji Xing Pharmaceuticals Announce an Exclusive Greater China License Agreement
LENZ Therapeutics has entered into an exclusive license agreement with Ji Xing Pharmaceuticals to develop and commercialize LNZ100 (aceclidine) and LNZ101 (aceclidine + brimonidine) for the treatment of presbyopia in Greater China. Ji Xing is a biotechnology company headquartered in Shanghai and backed by RTW Investments, a leading healthcare investment firm that is focused on advancing innovative medicines for patients with ophthalmic and cardiovascular diseases in China. In addition, RTW will invest $10 million in LENZ Therapeutics. Under the licensing agreement, LENZ will receive $15 million in upfront payments and may receive up to $95 million in additional payments, based on various prescribed development, regulatory and commercial milestones as well as royalty payments based on future net sales. More information can be found at https://www.businesswire.com/news/home/20220413005149/en/LENZ-Therapeutics-and-JIXING-Announce-an-Exclusive-Greater-China-License-Agreement-RTW-to-Invest-in-LENZ-Therapeutics/.
Alcon Reports First Quarter 2022 Results
Alcon has reported its financial results for the first quarter ended March 31, 2022. Worldwide sales for the first quarter 2022 were $2.2 billion, an increase of 14% on a reported basis and 18% on a constant currency basis, compared to the first quarter of 2021. Sales in both Surgical and Vision Care benefited from product innovation, improvements across geographies reflecting continuing recovery from the COVID-19 pandemic and sales from recent acquisitions. Surgical sales also included a one-time benefit related to implantables. Implantables growth reflected ongoing adoption of advanced technology intraocular lenses, led by Vivity. Implantables sales also included a one-time benefit in South Korea ahead of an insurance reimbursement change for presbyopia-correcting intraocular lenses that accounted for approximately 8% (cc) of implantables growth during the quarter. The company reported diluted earnings per share of $0.34 and core diluted earnings per share of $0.68. More information can be found at https://www.businesswire.com/news/home/20220508005067/en/Alcon-Reports-First-Quarter-2022-Results.