Orasis Pharmaceuticals News
15 articles
Orasis Announces Licensing Agreement With Optus Pharmaceuticals for Commercialization of Qlosi Eye Drops in Korea
Orasis Pharmaceuticals has entered into an exclusive licensing agreement with Optus Pharmaceuticals, allowing the latter to commercialize, import, and sell Orasiss novel eye drop, Qlosi, in Korea. This agreement is part of Orasiss strategy to expand its global reach and follows its recent Series D financing. The deal includes an upfront payment and milestone payments totaling $18 million, along with double-digit royalties on sales. Optus plans to launch Qlosi in Korea by 2026, pending regulatory approvals. This partnership is a significant step for Orasis in offering innovative solutions for presbyopia treatment worldwide.
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Orasis Pharmaceuticals Completes $78 Million Financing to Support Commercial Launch of Qlosi™ (pilocarpine hydrochloride ophthalmic solution) 0.4%
Orasis Pharmaceuticals announced the completion of a $78 million financing round to support the commercial launch of Qlosi, a corrective eye drop for presbyopia treatment. The Series D financing included a $68 million equity component co-led by Arboretum Ventures and Johnson & Johnson Innovation – JJDC, Inc., with participation from several other investors. Additionally, Orasis secured $15 million in structured capital from Catalio Capital Management, with $10 million drawn at closing. This funding will enable Orasis to launch Qlosi, providing a novel solution for presbyopia patients. The investment reflects confidence in Orasiss potential to impact the eye care market positively.
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Orasis Pharmaceuticals Announces FDA Approval of QLOSI™ (pilocarpine hydrochloride ophthalmic solution) 0.4% for the Treatment of Presbyopia
Orasis Pharmaceuticals has received FDA approval for QLOSI, a preservative-free, low-dose eye drop designed to treat presbyopia in adults. This approval is a significant milestone for the company, as QLOSI demonstrated efficacy, safety, and tolerability in two pivotal Phase 3 trials. The eye drop is expected to be commercially available in the U.S. in the first half of 2024. Orasis is backed by several investors, including Visionary Ventures and Sequoia Capital. The approval is based on trials involving over 600 patients, showing significant improvement in near visual acuity. The company aims to provide a flexible treatment option for the millions affected by presbyopia.
Customers
FDA Accepts Orasis Pharmaceuticals' New Drug Application for CSF-1 for the Treatment of Presbyopia
Orasis Pharmaceuticals announced that the FDA has accepted its New Drug Application for CSF-1, an investigational eye drop for treating presbyopia, with a PDUFA goal date set for October 22, 2023. The NDA is supported by Phase 3 clinical trials involving over 600 patients, which demonstrated significant improvements in near visual acuity. The acceptance of the NDA is a positive step towards the potential approval and commercial launch of CSF-1, addressing a significant unmet need for presbyopia treatment. Orasis is backed by several investors, including Visionary Ventures and Sequoia Capital.
Orasis Pharmaceuticals Submits New Drug Application for Investigational Novel Eye Drop Candidate, CSF-1, for the Treatment of Presbyopia
Orasis Pharmaceuticals has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for investigational CSF-1, a unique eye drop to improve near vision for people with presbyopia. The NDA is based on positive data from Phase 3 NEAR-1 and NEAR-2 clinical trials, which met primary and key secondary endpoints. The trials demonstrated statistically significant improvement in near visual acuity and minimal adverse events. With over 120 million people affected by presbyopia in the U.S., Orasis aims to provide an alternative treatment option. The company is funded by a diverse group of investors including Visionary Ventures, Sequoia Capital, and SBI (Japan) Innovation Fund.
Customers
Orasis Pharmaceuticals Appoints Teresa (Tes) Ignacio, M.D. as Vice President, Medical Affairs
Orasis Pharmaceuticals has appointed Teresa Ignacio as Vice President, Medical Affairs. Dr. Ignacio brings extensive experience in research and development, clinical and medical affairs. Orasis is developing CSF-1, a corrective eye drop for the treatment of presbyopia. The company has completed Phase 3 NEAR-1 and NEAR-2 clinical trials and is in the pre-commercialization phase. Orasis is funded by various investors including Visionary Ventures, Sequoia Capital, SBI (Japan) Innovation Fund, Bluestem Capital, LifeSci Venture Partners, Maverick Ventures Israel, and other private investors.
Management Changes
Orasis Raises $30 Million to Advance the Clinical Development of Novel Treatment for Presbyopia
Orasis Pharmaceuticals has closed a $30 million Series C financing round led by Bluestem Capital and Visionary Ventures. The funding will be used to advance Orasis lead eye drop candidate for the treatment of presbyopia symptoms through completion of its Phase 3 clinical trials. The funds will also be used for pre-commercialization activities. Orasis aims to provide a non-invasive solution for people with presbyopia, a condition that affects almost two billion people globally. The companys product candidate has shown promising results in previous clinical studies. The financing round is seen as a positive growth opportunity for Orasis.
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Orasis Pharmaceuticals reports presbyopia treatment trial success
Orasis Pharmaceuticals CSF-1 eye drops have successfully met the primary endpoint in a Phase 2b clinical study for the treatment of presbyopia. The eye drops demonstrated significant improvement in near visual acuity and had an exceptional safety and tolerability profile. The company sees this as a significant milestone and believes that CSF-1 has the potential to improve the quality of life for people with presbyopia. Among the investors in Orasis are Visionary Ventures, Sequoia Capital, SBI (Japan) Innovation Fund, LifeSci Venture Partners, and Maverick Ventures.
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VIDEO: Phase 2b results positive for Orasis presbyopia-correcting drops
Orasis Pharmaceuticals CEO, Elad Kedar, discusses positive results of a phase 2b trial for the companys CSF-1 eye drop formulation for presbyopia correction. The trial demonstrated positive safety, durability, and efficacy results.
Customers
Orasis CEO describes mechanism behind eye drop for presbyopia
Orasis Pharmaceuticals has announced the beginning of a phase 2b U.S. clinical trial for its presbyopia-correcting eye drop, CSF-1. The eye drop aims to restore near vision in people with presbyopia by creating a pinhole effect in the eye through pupil modulation. The company hopes that CSF-1 can provide a convenient and on-demand alternative to reading glasses for people with presbyopia. The eye drop has demonstrated a great safety profile in previous clinical trials. Orasis is currently focused on executing its phase 2b clinical study and will share the results in the near future.
Customers
Orasis Announces Initiation of Phase 2b Clinical Study of CSF-1 for the Treatment of Presbyopia
Orasis Pharmaceuticals has announced the initiation of a Phase 2b clinical study in the U.S. for the treatment of presbyopia. The study aims to evaluate the efficacy and safety of CSF-1, a corrective eye drop developed by Orasis as an alternative to reading glasses. Presbyopia is the inability to focus on near objects and affects more than 1.8 billion people worldwide. The Phase 2b study, which started enrolling patients in February 2019, is expected to provide important results for the development of CSF-1. Orasis Pharmaceuticals is funded by a diverse group of investors including Visionary Ventures, Sequoia Capital, SBI Innovation Fund, LifeSci Venture Partners, Maverick Ventures Israel, and other private investors.
Customers
Upcoming pharmaceutical treatments for presbyopia may prevent, delay surgery
Presbyopia Therapies PRX100 could be the first pharmaceutical approach for presbyopic near vision correction and may be the first new treatment to go through the FDA for presbyopia correction. The phase 2b clinical trial is in its final stages and phase 3 is anticipated to start soon. This treatment may delay or prevent the need for glasses, contact lenses, or surgical intervention.
Customers
Orasis Announces Appointments of Richard L. Lindstrom, Eric D. Donnenfeld, and John Berdahl to its Scientific Advisory Board
Orasis Pharmaceuticals has appointed three leading experts in ophthalmology, Dr. Richard L. Lindstrom, Dr. Eric D. Donnenfeld, and Dr. John Berdahl, to its scientific advisory board. The company is developing a corrective eye drop for the treatment of presbyopia as an alternative to reading glasses. The addition of these experts to the advisory board will accelerate the clinical development of the eye drop and improve the potential success of the product. Presbyopia affects over 1.8 billion people worldwide and there is a significant unmet need for a non-invasive treatment option. Orasis Pharmaceuticals is funded by a diverse group of investors including Visionary Ventures, Sequoia Capital, and SBI Innovation Fund.
Management Changes
Orasis Announces the Appointment of Jeffry Weinhuff as Chairman of the Board of Directors
Orasis Pharmaceuticals has appointed Jeffry Weinhuff as chairman of the board of directors. This appointment comes after the recent Series B financing led by Visionary Ventures, a venture capital fund focused on investing in ophthalmology companies. Orasis is developing a corrective eye drop called CSF-1 as an alternative to reading glasses for the treatment of presbyopia. The appointment of Weinhuff and the financing provide strong validation for Orasis approach. Weinhuff brings a wealth of experience in the field of ophthalmology and is expected to contribute to the companys continued success. Presbyopia affects over 1.8 billion people worldwide and existing treatment options are either cumbersome or invasive. Orasis aims to provide a pharmacological alternative to improve the quality of life for those with presbyopia.
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Orasis Pharmaceuticals Closes $13M Series B Financing - FinSMEs
Orasis Pharmaceuticals has closed a $13M Series B financing round led by Visionary Ventures. The company develops an innovative eye drop for the treatment of presbyopia symptoms and will use the funds to advance its lead product candidate, CSF-1, through clinical trials and pre-commercial activities.
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