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The launch of emerging therapies, such as LNZ100 by Lenz Therapeutics, Phentolamine Ophthalmic Solution 0.75% by Viatris and Ocuphire Pharma, BRIMOCHOL PF (VT-1011) by Visus Therapeutics, among others will significantly impact the presbyopia market during the forecast period (2024–2034). LAS VEGAS, Nov. 14, 2024 /PRNewswire/ -- Presbyopia is an age-related refractive condition marked by a gradual decline in near vision, typically emerging between ages 40 and 60. It results from the lens losing elasticity and becoming thicker, harder, and less flexible due to structural protein changes. This impairs the lens's ability to adjust for near vision, reducing accommodative amplitude. Presbyopia can be classified into incipient, functional, absolute, premature, and nocturnal types, each representing different stages and manifestations of the condition. As per DelveInsight's assessment, the total prevalent cases of presbyopia in the 7MM were ~325 million in 2023. These cases are expected to increase at a significant CAGR of 1.1% during the forecast period i.e., 2024–2034. Based on severity, presbyopia was bifurcated into mild and moderate to severe presbyopia, in EU4 and the UK, moderate to severe presbyopia accounted for the maximum number of cases, which was approximately 95 million. Treatment options for presbyopia mainly consist of corrective lenses and surgical procedures. Non-invasive methods, such as reading glasses, bifocals, and progressive lenses, enhance vision at different distances. Contact lenses, including multifocal and monovision types, present another option. Surgical treatments like LASIK, conductive keratoplasty, and corneal inlays modify the eye's focusing capabilities. Recently, eye drops like pilocarpine hydrochloride have gained attention as a promising treatment, as they temporarily enhance near vision by constricting the pupil to improve depth of field. For non-drug treatments, reading glasses enable clear vision for tasks up close, while bifocals combine two prescriptions in a single lens to correct both distance and near vision. Progressive lenses provide a smooth transition between different vision zones with no visible lines. Contact lenses designed for presbyopia, like multifocal or accommodating lenses, offer greater convenience and a broader field of vision compared to glasses. For those looking for a more lasting solution, LASIK surgery can correct presbyopia by reshaping the cornea, although it tends to be more effective for younger individuals with stable vision needs. Conductive keratoplasty uses radiofrequency energy to enhance near vision by creating small spots on the cornea, serving as a non-invasive option. Corneal inlays involve inserting a tiny device into the cornea to enhance near vision while maintaining distance vision. Two FDA-approved treatments, VUITY and QLOSI, represent significant advancements in ophthalmology. Learn more about the FDA-approved presbyopia drugs @ Drugs for Presbyopia Treatment VUITY (1.25% pilocarpine HCl ophthalmic solution), developed by Allergan, is a groundbreaking treatment for presbyopia that received FDA approval in October 2021. This prescription eye drop functions by constricting the pupil, which improves near and intermediate vision while minimally impacting distance vision. Utilizing the miotic effects of pilocarpine, VUITY enhances focus for close-range activities, presenting a non-invasive alternative to reading glasses. Its approval represents a significant step forward in managing presbyopia, offering patients a convenient and effective solution to relieve the symptoms associated with the condition. QLOSI (0.4% pilocarpine hydrochloride ophthalmic solution), developed by Orasis Pharmaceuticals, is a new treatment for presbyopia that received approval from the US FDA in October 2023. This formulation utilizes pilocarpine, a cholinergic muscarinic agonist, to enhance the eye's ability to focus on nearby objects. The launch of QLOSI is expected in the latter half of 2024, providing patients with a non-surgical option for addressing age-related vision deterioration. To know more about presbyopia treatment options, visit @ New Treatment for Presbyopia The dynamics of the presbyopia treatment market are anticipated to change during the forecast period as companies across the 7MM are diligently working towards the development of novel treatment options to combat the existing treatment-based unmet needs. Key players, such as Viatris and Ocuphire Pharma (Phentolamine Ophthalmic Solution 0.75%), Visus Therapeutics (BRIMOCHOL PF), Lenz Therapeutics (LNZ100), and others are involved actively in developing potential treatment scopes. Discover which therapies are expected to grab major presbyopia market share @ Presbyopia Market Report LNZ100, developed by Lenz Therapeutics, is an experimental treatment for presbyopia that is currently progressing through Phase III clinical trials. This medication works by targeting and modulating the intraocular muscles to restore the eye's ability to focus on nearby objects, which is a common problem associated with aging. LNZ100 utilizes a unique mechanism of action that selectively modulates specific receptors in the eye to improve accommodation. Administered as eye drops, LNZ100 provides a non-invasive alternative to surgical treatments. The company intends to submit a New Drug Application (NDA) to the FDA in mid-2024, with plans for a market launch in the second half of 2025, establishing it as a significant therapeutic option for presbyopia management. BRIMOCHOL PF (VT-1011) is a drug under development by Visus Therapeutics aimed at treating presbyopia. This combination therapy includes carbachol and brimonidine tartrate and is designed to enhance near vision by utilizing its pharmacodynamic properties. Currently, BRIMOCHOL PF is in Phase III of clinical development. Following promising results from Phase II trials, it has advanced to this crucial stage, where the primary focus is to validate its therapeutic effects and detect any possible side effects before pursuing regulatory approval for market launch. The company plans to submit its New Drug Application (NDA) in the latter half of 2024, intending to provide a new treatment option for presbyopia. Phentolamine Ophthalmic Solution 0.75%, being developed by Viatris and Ocuphire Pharma, aims to treat presbyopia. This solution enhances near vision temporarily while maintaining distance vision, providing a non-surgical option to reading glasses or contact lenses. The development of Phentolamine Ophthalmic Solution 0.75% is in the final phases of clinical trials. It has successfully finished Phase II studies, which showed its efficacy and safety for the intended purpose. The product is currently in Phase III clinical trials to further verify its effectiveness and safety before pursuing regulatory approval. Discover more about drugs for presbyopia in development @ Presbyopia Clinical Trials The anticipated launch of these emerging therapies for presbyopia are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the presbyopia market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for presbyopia is expected to grow from USD ~17 billion in 2023 with a CAGR of 3.2% by 2034. The anticipated increase in market size is driven by advancements in treatment options, greater healthcare access, and a rising incidence of the condition, which together foster a higher demand for innovative and effective therapies. DelveInsight's latest published market report titled as Presbyopia Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the presbyopia country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The presbyopia market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Prevalent Cases of Presbyopia Total Diagnosed Prevalent Cases of Presbyopia Gender-specific Diagnosed Prevalent Cases of Presbyopia Age-specific Diagnosed Prevalent Cases of Presbyopia Severity-specific Diagnosed Prevalent Cases of Presbyopia The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM presbyopia market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this presbyopia market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the presbyopia market. Also, stay abreast of the mitigating factors to improve your market position in the presbyopia therapeutic space. Related Reports Presbyopia Pipeline Presbyopia Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key presbyopia companies, including Orasis Pharmaceuticals, Novartis, Cellix Bio, Visus Therapeutics, AbbVie, Vyluma, Lenz Therapeutics, Ocuphire Pharma, JIXING Pharmaceuticals, Eyenovia, among others. Myopia Market Myopia Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key myopia companies such as Vyluma, Inc., Sydnexis, Inc., Ocumension limited, Santen Pharmaceutical, Cloudbreak therapeutics, Nevakar, Inc., Eyenovia, Stuart Therapeutics, Cellix Bio, JeniVision, Zhaoke Ophthalmology, among others. Myopia Pipeline Myopia Pipeline Insight – 2024 report provides comprehensive insights into pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key myopia companies involved, such as Vyluma, Inc., Sydnexis, Inc., Ocumension limited, Santen Pharmaceutical, Cloudbreak therapeutics, Nevakar, Inc., Eyenovia, Stuart Therapeutics, Cellix Bio, JeniVision, Zhaoke Ophthalmology, among others. Myopia Progression Market Myopia Progression Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key myopia progression companies such as Johnson & Johnson Vision Care Inc, Beijing Airdoc Technology Co., Ltd, Essilor International, Menicon Co., Ltd., SightGlass Vision Inc, Indizen Optical Technologies, S.L.U., Bausch & Lomb Incorporated, Coopervision Inc, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Primary endpoint was met with 74% of participants dosed with LNZ100 achieving three-lines or greater improvement at 3 hours post treatment，and maintaining their optimal distance visual acuity (i.e., not losing 5 or more letters). The difference in efficacy was statistically significant in the LNZ100 treatment group compared to the vehicle group (p<0.0001) Rapid onset and long duration shown with 69% of participants achieving three-lines or greater improvement at 30 minutes and 30% at 10 hours 91% of participants indicated they noticed an improvement in their near vision LNZ100 could potentially be the best-in-class non-invasive treatment for presbyopia SHANGHAI, China and SAN DIEGO, Oct. 27, 2024 (GLOBE NEWSWIRE) -- Corxel Pharmaceuticals (CORXEL) and LENZ Therapeutics (Nasdaq: LENZ) today announced positive topline data from the Phase 3 JX07001 clinical trial of LNZ100 in patients with presbyopia in China. CORXEL is a leading biotech company committed to bringing innovative science and medicines to underserved patients with serious and life-threatening diseases. LENZ Therapeutics is a pre-commercial biopharmaceutical company focused on developing the first and only aceclidine-based eye drop to improve near vision in people with presbyopia. In this China Phase 3 safety and efficacy trial, LNZ100 (1.75% aceclidine HCl) 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). More results 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 at 3 hours 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. The study was a Phase 3, multicenter, randomized, double-blind, vehicle-controlled study, including a 4-week efficacy study followed by a 5-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, with a broad enrollment criteria of between 45 and 75 years of age with a refractive range of -4.0D SE to +1.0D SE, including those who had undergone laser-assisted cornea refractive surgery/monofocal IOL implantation. Professor Jia Qu, Principal Investigator and Co-Principal Investigator，Vice Chairman of Ophthalmology Branch, Chinese Medical Association, Director of optometry department, Wenzhou Medical University said: “we are very pleased with the results of the LNZ100 trial, particularly the significant efficacy and favorable safety profile of LNZ100 in patients with presbyopia, demonstrating an important advance in the field of presbyopia treatment in China. Currently, patients mainly rely on wearing eyeglasses as treatment for presbyopia. There is a large unmet need for non-invasive and reversible treatments. We expect that LNZ100 will fill this vacuum and become an innovative force in the treatment of presbyopia in China, providing more patients with the hope of clear vision." Professor Fan Lyu, Principal Investigator and Co-Principal Investigator，Head of optometry working-group under Ophthalmology Branch, Chinese Medical Association, Director of National Clinical Medical Research Centre for Eye Diseases said: "The main active ingredient of LNZ100, aceclidine, causes temporary pupil constriction, resulting in an optical effect that significantly extends the depth of focus and improves the quality of vision. The statistically significant data and clinically meaningful outcomes observed in the trials provide strong support for the efficacy and safety of LNZ100. We anticipate that LNZ100 will be a practical treatment option for a wide spectrum of patients and will have a favorable impact on paradigm shift of helping improve near-vision in the Chinese presbyopia population. “We are especially grateful to all the hard-working and dedicated researchers, partner organizations and all the volunteers who participated in the study,” Sandy Mou, Board Executive Director and Chief Executive Officer of CORXEL, said. “The common goal is to benefit hundreds of millions of people around the world, to set an international leading research benchmark, and to introduce novel treatment concepts and potentially optimal products to China first, providing a safe and convenient treatment option for the vast number of presbyopia patients. Looking ahead, we will actively communicate and cooperate with drug regulatory authorities to expedite the submission and approval of LNZ100. We believe that LNZ100 will not only significantly improve patients' vision and quality of life, but will also have a profound impact on the field of presbyopia treatment and research in China.” “We would like to first congratulate the team at CORXEL for their effort in their Phase 3 clinical study in China. We are pleased with the impressive and consistent performance demonstrated by LNZ100 in our collective studies, further validating the vision of targeting an ‘all eyes, all day’ solution,” said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics. “With this data, we believe LNZ100 has further enhanced its potential as a global therapy and is further on its path towards providing access to the estimated 400 million people with presbyopia in China. This data signifies a tremendous joint effort between the CORXEL and LENZ teams and comes in rapid succession to the recent FDA acceptance of our New Drug Application for LNZ100 in the United States.” About PresbyopiaPresbyopia 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. It is estimated that more than 400 million people in China suffer from presbyopia.  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 invasive operation, has a 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.  About LNZ100LNZ100 (aceclidine) eye drops are being developed by LENZ Therapeutics and CORXEL acquired the Greater China rights for the 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 CORXELCORXEL, formerly named Ji Xing Pharmaceuticals, is a leading biotech company headquartered in US and China committed to bringing innovative science and medicines to underserved patients with serious and life-threatening cardiometabolic diseases. Backed by RTW Investments, CORXEL was founded in 2019 to develop and commercialize novel, innovative therapeutics to treat unmet medical needs in diseases. With a strong and further developing asset pipeline, industry leading talent, and patient-centric focus, CORXEL is dedicated to deliver a meaningful and lasting impact on patients. The full portfolio of CORXEL consists of 2 assets with global rights and 4 assets with Greater China rights in late-stage clinical development. The portfolio with global rights are JX09 for hypertension and JX10 for acute ischemic stroke (AIS), while the portfolio with Greater China rights include aficamten, etripamil, varenicline solution nasal spray/US brand name TYRVAYA®, and LNZ100. For further information about CORXEL, please visit www.corxelbio.com.   About LENZ TherapeuticsLENZ Therapeutics is a pre-commercial biopharmaceutical company focused on the development and commercialization of the first and only aceclidine-based eye drop to improve near vision in patients with presbyopia. LENZ’s product candidate, LNZ100 is a preservative-free, single-use, once-daily eye drop containing aceclidine. LNZ100 was evaluated in the registration-enabling Phase 3 CLARITY study as a potential therapy for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States. The U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025 for LNZ100. LENZ is committed to commercializing an ideal pharmaceutical presbyopia solution that enhances vision for “all eyes, all day”. LENZ is headquartered in San Diego, California. For more information, visit: LENZ-Tx.com. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of United States federal securities laws. You can identify forward-looking statements by words such as “may,” “will,” “could,” “can,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “poised,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, but not all forward-looking statements will contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the potential of LNZ100 to have best-in-class performance and LNZ100 as a global therapy; the size of the addressable population for LNZ100; expectations regarding the commercial opportunity and beneficial characteristics of LNZ100; and plans and expectations regarding commercialization of LNZ100, if approved. These statements are based on numerous assumptions concerning the development of LENZ’s products and target markets and involve substantial risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievement to be materially different from the information expressed or implied by these forward-looking statements, including those risk factors described in the section titled “Risk Factors” in LENZ’s Quarterly Report on Form 10-Q filed for the quarter ended June 30, 2024 and in LENZ’s subsequent filings with the SEC. LENZ cannot assure you that the forward-looking statements in this press release or the assumptions upon which they are based will prove to be accurate. The forward-looking statements in this press release are as of the date of this press release. Except as otherwise required by applicable law, LENZ disclaims any duty to update any forward-looking statements. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. LENZ Therapeutics Contact: Dan Chevallard IR@LENZ-Tx.com