Pilocarpine Hydrochloride

Submission of New Drug Application (NDA) in Australia by Aspen Pharmacare Australia (Aspen Australia) marks the first ex-U.S. regulatory submission (known as QLOSI® in the U.S.) PONTE VEDRA, Fla., July 15, 2026 /PRNewswire/ -- Orasis Pharmaceuticals and Aspen Australia announced that Aspen has submitted a New Drug Application in Australia to the Therapeutic Goods Administration (TGA) for the review and approval of BESKA (pilocarpine hydrochloride ophthalmic solution) 0.4% for the treatment of presbyopia in adults (known as QLOSI in the US market). Aspen will be responsible for the distribution and marketing of BESKA in Australia. The NDA submission was supported by positive data from two pivotal, Phase 3 clinical trials, NEAR-1 and NEAR-2, which evaluated the efficacy, safety and tolerability in more than 600 adult patients with presbyopia. Both trials met their 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. All adverse events reported were in the single digits, with headache (6.8%) and instillation site pain (5.8%) being the most commonly reported treatment-related adverse events (TRAEs).1 "We are excited about this important milestone as we work with trusted partners to expand the availability of our treatment for presbyopia in additional markets around the world," said Elad Kedar, Chief Executive Officer of Orasis Pharmaceuticals. "We know Aspen's highly experienced team is well-positioned to work with local regulators to gain approval and ultimately to commercialize Qlosi, with the trademark BESKA in Australia, bringing to eye care providers a flexible option for their presbyopia patients seeking an alternative to reading glasses." "Aspen is proud to have completed the submission for Beska in Australia. This product is a great enhancement to our existing portfolio as we seek to improve the visual health and quality of life in the communities we serve. We look forward to the continued collaboration with Orasis Pharmaceuticals as we prepare for the approval and launch next year," said Trevor Ziman, Regional Chief Executive Asia Pacific. About Presbyopia 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.2 There are almost two billion people globally and more than 128 million people in the U.S. living with presbyopia.2,3 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 presbyopia patients. Presbyopia can be diagnosed during an eye exam conducted by an eye care professional.4 About Qlosi/Beska Qlosi/Beska (pilocarpine hydrochloride ophthalmic solution) 0.4% is a novel, prescription eye drop approved in the U.S. for the treatment of presbyopia in adults. Beska is not approved in Australia yet, but an NDA has been submitted and accepted for review and approval by the TGA. Qlosi's EyeQ Formulation™ delivers the lowest effective concentration of pilocarpine approved in a preservative-free eye drop, with a near-neutral pH and dual lubricating agents to provide enhanced safety and patient comfort without compromising on efficacy.1,5,6 Qlosi 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 without negatively impacting distance vision. In clinical trials, the most commonly reported treatment-related adverse events (TRAEs) were headache and instillation site pain, at rates of 6.8% and 5.8%, respectively. For more information, visit and follow us on LinkedIn, Facebook and Instagram. About Orasis Pharmaceuticals Orasis Pharmaceuticals is an ophthalmic pharmaceutical company delivering solutions to reshape vision possibilities. Orasis has developed Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4%, a novel, corrective prescription eye drop for the treatment of presbyopia, or age-related blurry near vision, in adults. Orasis is led by a collaborative team of industry executives and eye care professionals working to transform the standard of care for near vision correction. Orasis is funded by a diverse group of sophisticated and experienced life science and healthcare investors. Orasis has offices in the United States and Israel. For more information, visit and follow us on LinkedIn. About Aspen Pharmacare Australia Pharmaceuticals Aspen Pharmacare Australia is one of Australia's leading pharmaceutical companies, dedicated to improving health and quality of life in the communities it serves, through a diverse portfolio of over 150 prescription and over the counter (OTC) medicine brands. Since commencing operations in Australia in 2001, the company has grown rapidly through strategic acquisitions and partnerships, serving both Australia and New Zealand with high-quality, accessible medicines. Qlosi U.S. Indication and Important Safety Information Indication and Usage Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4%, for topical ophthalmic use is a cholinergic agonist indicated for the treatment of presbyopia in adults. Important Safety Information CONTRAINDICATIONS Hypersensitivity WARNINGS AND PRECAUTIONS Advise patients to not drive or operate machinery if vision is not clear (e.g., blurred vision). Exercise caution in night driving and other hazardous occupations in poor illumination. Rare cases of retinal detachment have been reported with miotics. Examination of the retina is advised in all patients prior to initiation of therapy. Advise patients to seek immediate medical care with sudden onset of flashes of lights, floaters or vision loss. Qlosi is not recommended to be used when iritis is present. Qlosi should not be administered while wearing contact lenses. Remove lenses prior to the installation of Qlosi and wait 10 minutes before reinsertion. Avoid touching the tip of the vial to the eye or any other surface. ADVERSE REACTIONS The most common adverse reactions (5% to 8%) are instillation site pain and headaches. Please see full Prescribing Information here: qlosi.com/prescribing-information You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Media Contact: [email protected] ©2026 Orasis Pharmaceuticals, Inc. All Rights Reserved. | QLO.00750 | 07/2026 SOURCE ORASIS PHARMACEUTICALS 21% more press release views with Request a Demo

Shanghai, China – June 8, 2026 – Everest Medicines (HKEX 1952.HK, “Everest”, or the “Company”), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced that it has entered into an Asset Purchase Agreement with Corxel Pharmaceuticals Limited (“CORXEL”). Under the agreement, the Company has acquired the rights to develop, manufacture, and commercialize LNZ100 (1.44% aceclidine, U.S. brand name VIZZ) in Greater China, including Chinese mainland, Hong Kong SAR, Macao SAR, and Taiwan region. Everest will pay an upfront payment and potential development milestone payments. As part of this agreement, Everest will be assigned and transferred the rights and obligations under the LENZ License Agreement entered into by CORXEL in April 2022 and certain related ancillary agreements. This transaction is expected to further expand the Company’s innovative product portfolio, strengthen its presence in ophthalmology, and enhance overall strategic synergies across its business. LNZ100 is a once-daily prescription eye drop indicated for the treatment of presbyopia. Its active ingredient, aceclidine, is a small molecule acetylcholine receptor agonist that causes pupil contraction, or miosis, creating a pinhole effect that improves near vision. Studies have shown that aceclidine's mechanism of action (MOA) is well positioned to create a pinhole pupil effect while avoiding the impairment of distance vision called myopic shift. Aceclidine's unique pupil selective MOA, in which miosis is decoupled from myopic shift, is expected to allow it to target a broad patient population. LNZ100 received approval in the United States in July 2025 and was commercially launched in October of the same year. In China, the New Drug Application (NDA) for LNZ100 was submitted in September 2025, with approval expected in the first quarter of 2027. The therapy has the potential to address a significant unmet medical need in China and position itself as a best-in-class, non-invasive treatment option for presbyopia. "The acquisition of LNZ100 represents an important step in advancing Everest’s strategic focus in ophthalmology. LNZ100 is a differentiated asset with meaningful clinical value and strong commercial potential in the treatment of presbyopia,” said Yifang Wu, Chairman of the Board of Everest Medicines. “As the presbyopia patient population continues to grow, significant unmet needs remain in non-invasive treatment options. We believe LNZ100 has the potential to offer patients a novel, non-invasive therapeutic option and to further broaden the landscape of innovative ophthalmic treatments. The product has already been approved in the United States and is currently under regulatory review in China. We will continue to advance its development and commercialization to make this therapy accessible to presbyopia patients." Ms. Sandy Mou, Board Executive Director and Chief Executive Officer of CORXEL, said: “We are confident that Everest Medicines’ strong commercialization capabilities will accelerate LNZ100’s market access and bring this innovative treatment to more presbyopia patients in China. Presbyopia is a physiological phenomenon associated with aging that results in a progressively worsening ability to see nearby objects clearly. It is caused by the gradual hardening of the lens. This results in a decline of the eye’s adjustment function, and the inability to focus the image of nearby objects on the retina, leading to a decline in near vision. Studies have shown that the onset of presbyopia typically occurs around the age of 38, reaching a prevalence rate of nearly 100 percent at the age of 52 in China. Currently, the treatment options for presbyopia are very limited. Wearing glasses requires frequent removal and insertion, causing many inconveniences in work and life. Surgery, as an irreversible and invasive operation, has very limited acceptance. There are no approved drugs for the treatment of presbyopia in China and the medical need for non-invasive, safe, efficient and reversible treatments for presbyopia remains unsolved.  The NDA acceptance of LNZ100 by the National Medical Products Administration (NMPA) of the People’s Republic of China is based on the data from China Phase 3 Trial. The study was a Phase 3, multicenter, randomized, double-blind, vehicle-controlled study, including a 4-week efficacy study followed by a 6-month extension safety study, designed to evaluate the efficacy and safety of LNZ100 (an aceclidine-based ophthalmic solution) in participants with presbyopia. The objectives were to assess the potential of LNZ100 to improve near vision among Chinese presbyopia patients and to evaluate the efficacy and safety profiles.  The trial has enrolled 300 participants. The results showed that LNZ100 achieved the primary endpoint and key secondary endpoints, with statistically significant three-lines or greater improvement in Best Corrected Distance Visual Acuity (BCDVA) at near, and maintaining their optimal distance visual acuity (i.e., not losing 5 or more letters). Results also showed (all p<0.0001): • Rapid onset: 84% and 69% achieved two-lines and three-lines or greater improvement at 30 minutes, respectively. • 3 hours post treatment: 88% and 74% achieved two-lines and three-lines or greater improvement respectively,and maintained their optimal distance visual acuity (i.e., not losing 5 or more letters). • Long duration: 61% and 30% achieved two-lines and three-lines or greater improvement at 10 hours, respectively. • LNZ100 was well-tolerated with no serious treatment-related adverse events observed in the trial. About LNZ100 Developed by LENZ Therapeutics (Nasdaq: LENZ), LNZ100 eye drops received U.S. FDA approval in July 2025 under the brand name VIZZ. CORXEL acquired the Greater China rights for its development and commercialization in April 2022. LNZ100 is formulated with aceclidine, a miotic, and designed to achieve optimal pupil diameter without impacting distance vision, a key limitation of other miotics. Miotics are compounds that cause pupil constriction, or miosis, creating a pinhole effect that enables better focus of incoming light from near objects onto the retina. Research has shown that a pupil diameter below two millimeters (2 mm) is optimal for presbyopia treatment and results in clinically meaningful improvement in near vision. Unlike other miotics such as pilocarpine and carbachol, aceclidine’s mechanism of action is pupil-selective, meaning it can activate the iris sphincter muscle and cause miosis of the pupil to a diameter below 2 mm without overstimulating the ciliary muscles that can cause a myopic shift and impair distance vision. As a result, aceclidine does not require any remaining accommodation to improve near vision, broadening its benefits to older presbyopes whose lens has lost this capacity. Therefore, we expect that users may be able to benefit from treatment even as they age from mid-40s to well into their mid-70s and across a broad range of refractive errors, as demonstrated in clinical testing to date.   About Everest Medicines Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative pharmaceutical products that address critical unmet medical needs for patients in global markets. The management team of Everest Medicines has deep expertise and an extensive track record both in China and with leading global pharmaceutical companies. The Company’s therapeutic areas of focus include CKM (cardiovascular, kidney, and metabolic), autoimmune, ophthalmology and critical care. Everest Medicines has developed a fully integrated commercialization platform that combines omnichannel commercial capabilities with end-to-end product lifecycle management. Leveraging its proprietary mRNA platform, the Company is advancing its existing pipeline, including mRNA in vivo CAR-T and mRNA cancer vaccines, while selectively expanding into additional high-value therapeutic areas with blockbuster potential, and accelerating its global expansion. For more information, please visit the Company’s website: www.everestmedicines.com. About CORXEL CORXEL is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for patients with cardiometabolic conditions around the world. CORXEL is led by an experienced management team that has a strong track record of identifying, in-licensing and developing attractive clinical product candidates directed at validated targets with proven mechanisms of action (MoAs). CORXEL’s diverse portfolio of clinical-stage product candidates has the potential to redefine treatment standards and address key limitations of current therapies for multiple cardiometabolic indications. CORXEL is developing selective small molecule compounds across the cardiometabolic spectrum with the lead product candidate CX11, an oral small molecule GLP-1 RA under clinical development for obesity and overweight conditions and T2DM, JX10, a thrombolytic and anti-inflammatory agent for acute ischemic stroke and CX12, an oral small molecule amylin RA under pre-clinical development. CORXEL also has additional small molecule programs in development targeting validated obesity targets. For further information about CORXEL, please visit www.corxelbio.com.   Forward-Looking Statements This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident” and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.