Latanoprost

Publication in the Journal of Ocular Pharmacology and Therapeutics highlights the ability of the Optejet to achieve a therapeutic dose of medication with far less exposure to harmful preservatives Additional presentation at the American Academy of Optometry summarizes a Phase 4 study of Mydcombi demonstrating that clinically relevant mydriasis can be achieved with a half-dose per eye NEW YORK, Oct. 23, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company, today announced a publication in the Journal of Ocular Pharmacology and Therapeutics as well as an upcoming presentation at the American Academy of Optometry’s “Academy 2024 Indianapolis” Annual Meeting. Publication in the Journal of Ocular Pharmacology and Therapeutics The peer-reviewed paper highlights the ability of Eyenovia’s proprietary Optejet dispenser to deliver a therapeutic dose of latanoprost with far less exposure to the preservative benzalkonium chloride (BAK) than traditional eye drops. BAK, in larger volumes, can cause unwanted side effects, including cytotoxicity, cytoplasmic shrinkage, and loss of cell-cell contact, and expression of chemokine (C-C motif) ligand 2 and interleukin-6 (markers of inflammation). In contrast, this in-vitro study of latanoprost plus BAK delivered in the same amount by the Optejet dispenser (8 microliters) avoided the cytotoxicity associated with larger volumes found in eye drops and was similar to no treatment controls and BAK-free latanoprost drops. “We have shown in prior studies the ability of the Optejet dispenser to achieve a therapeutic dose of medication with approximately 80% less volume and exposure to harmful preservatives than traditional eye drops,” stated Michael Rowe, Chief Executive Officer of Eyenovia. “The implication here is that preserved medications may not need to be reformulated to get many of the benefits of non-preserved products if delivered with the Optejet. We believe this creates potential opportunities for the Optejet to improve the administration of topical ocular therapeutics well beyond our own development pipeline.” Presentation at the American Academy of Optometry’s “Academy 2024” Eyenovia also announced today an upcoming presentation at the American Academy of Optometry’s “Academy 2024 Indianapolis,” which is being held November 6-9, in Indianapolis, IN. The presentation details the results of an open-label Phase 4 study of 1% tropicamide and 2.5% phenylephrine ophthalmic metered spray, similar to Mydcombi, Eyenovia’s commercially available product for inducing mydriasis. Twenty-nine subjects completed the study and administered one spray. Baseline pupil diameter (PD) for all eyes was 2.74±0.48 mm. Mean change in PD from baseline to 30 minutes was 3.69±1.25 mm. At 30 minutes post-dosing, mean PD was 6.42±1.25 mm, with 67% and 43% of eyes dilated to ≥ 6mm and 7mm, respectively. The majority of patients returned to functional vision (PD ≤ 5 mm) as early as 3.5 hours post-instillation, with 93% reaching that point by six hours. Safety outcomes were favorable, as only mild adverse events were reported (dry eye and mild instillation site pain) all of which resolved without intervention. “We conducted this study to address questions from doctors about modulating dosing for patients who may benefit from a lower dose of tropicamide or phenylephrine,” stated Dr. Julie Whitcomb, Senior Director of Medical Affairs at Eyenovia. “What we found in this study was that a half dose may also provide clinically relevant pupil dilation, was well-tolerated, and had a desirable shorter duration of effect.” Presentation details: Title:An Open Label, Phase 4 Study of the Safety and Efficacy of Fixed Combination Tropicamide 1% and Phenylephrine 2.5% Ophthalmic Spray (MydCombi®)Poster:#109, Exhibit Hall HPresenter:Dr. Josianne Manasse, OD, SUNY College of OptometryDate/time:Friday, November 8th, 1:00-3:00pm For additional information on the Expo: https://aaopt.org/meetings/academy-2024-indianapolis/ About Eyenovia, Inc. Eyenovia, Inc. (NASDAQ: EYEN) is an ophthalmic technology company developing a pipeline of advanced products based on its Optejet platform. Eyenovia is currently focused on the commercialization of Mydcombi® for mydriasis, clobetasol propionate ophthalmic suspension, 0.05% for post-surgical pain and inflammation, as well as the ongoing late-stage development of medications in the Optejet device for pediatric progressive myopia as well as out-licensing for additional indications. For more information, visit Eyenovia.com. The Eyenovia Corporate Information slide deck may be found at ir.eyenovia.com/events-and-presentations. PLEASE GO TO MYDCOMBI.COM FOR IMPORTANT SAFETY INFORMATION for MYDCOMBI™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% PLEASE GO TO CLOBETASOLBID.COM FOR IMPORTANT SAFETY INFORMATION for Clobetasol Propionate Ophthalmic Suspension 0.05% Forward-Looking StatementsExcept for historical information, all the statements, expectations and assumptions contained in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions, including the timing and scale of acceptance and use of our approved products. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and in some cases are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors discussed from time to time in documents which we file with the U.S. Securities and Exchange Commission. In addition, such statements could be affected by risks and uncertainties related to, among other things: risks of our clinical trials, including, but not limited to, the costs, design, initiation and enrollment, timing, progress and results of such trials; the timing of, and our ability to submit applications for, obtaining and maintaining regulatory approvals for our products and product candidates; the potential advantages of our products, product candidates and platform technology; the rate and degree of market acceptance and clinical utility of our products and product candidates; our estimates regarding the potential market opportunity for our products and product candidates; reliance on third parties to develop and commercialize our products and product candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for our products and product candidates; intellectual property risks; changes in legal, regulatory, legislative and geopolitical environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products and product candidates; and our competitive position. Any forward-looking statements speak only as of the date on which they are made, and except as may be required under applicable securities laws, Eyenovia does not undertake any obligation to update any forward-looking statements. Eyenovia Contact:Eyenovia, Inc.Andy Jones Chief Financial Officerajones@eyenovia.comEyenovia Investor Contact:Eric RibnerLifeSci Advisors, LLCeric@lifesciadvisors.com(646) 751-4363Eyenovia Media Contact:Eyenovia, Inc.Norbert LoweVice President, Commercial Operationsnlowe@eyenovia.com

SHANGHAI, Aug. 12, 2024 /PRNewswire/ -- On August 12, Ocumension Therapeutics (Shanghai) Co., Ltd. (01477.HK, hereinafter referred to as "Ocumension" or the "Company") released its 2024 Interim Results Report. During the reporting period, the company achieved operating revenue of RMB 168 million, representing a year-on-year increase of 61.6%. The gross margin was 59.2%, and the adjusted loss amounted to RMB 101 million, narrowing by 20.0% year-on-year. This significant growth in performance is attributed to the accelerated advancement of the company's commercialization process and the steady increase in market penetration. Additionally, the company's operational efficiency improved markedly, and its cost control capabilities were further optimized. Rapid Expansion of Core Products Leads to New Growth in the Ophthalmic Drug Market During the reporting period, the company's core products expanded rapidly, with ongoing efforts to build commercialization capabilities and continuously enhance core competitiveness. In the first half of the year, the company's commercialized products generated revenue of RMB 168 million, reflecting a year-on-year growth of 61.6%. Several products, including OT-204, OT-1004, and OT-306, all saw steady increases in market share, contributing to the strong market position of Ocumension in the ophthalmic drug market. Notably, one of the company's commercialized products, Yusheying® (for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye), was included in the National Medical Insurance Directory at the beginning of the year. The demand for this medication has rapidly increased over the past six months. Since the implementation of the new insurance directory, Yusheying® has completed nearly 2,000 injections in the first half of the year, showcasing its market potential and the high level of patient recognition. Furthermore, during the reporting period, Ocumension remained committed to broadening product accessibility to benefit a wider patient population. The company pursued a dual strategy: on one hand, it actively expanded hospital coverage and accelerated product hospitalizations to fully tap into the commercial potential of its mature products; on the other hand, it promoted new products through academic outreach, driving a leap in sales revenue. Nationally, the company has covered 10,970 hospitals, including 1,652 tertiary hospitals, supported by a professional commercial team of over 250 people. This extensive commercial network lays a solid foundation for the future market entry of Ocumension's ophthalmic product portfolio. In response to the increasing commercialization demand, Ocumension's Suzhou factory successfully initiated the first batch of commercial production of 0.3% Sodium Hyaluronate Eye Drops (0.4ml: 1.2mg) in July this year. Leveraging advanced manufacturing processes, efficient supply chain management, and a commitment to excellence, the first batch of "Ocumension-made" Sodium Hyaluronate Eye Drops will be produced at the fastest speed, bringing relief to patients suffering from dry eye syndrome. Strong R&D Capabilities, Comprehensive Development of Ophthalmic Drug Pipeline On July 5, a national plan supporting the development of innovative drugs throughout the entire chain was introduced. The central government has provided multi-dimensional support for the development of innovative drugs, which has greatly boosted market confidence. According to industry experts, the current surge in domestic R&D enthusiasm means that the strength of a company's R&D capabilities will be a key factor in determining its ability to stand out and succeed in this "marathon" race. According to the announcement, R&D expenses in the first half of 2024 reached RMB 59 million. Since its listing, Ocumension has prioritized investment in R&D, which, supported by its outstanding R&D capabilities and forward-looking strategic planning, has established its leading position in the field of ophthalmic drugs. This also provides the necessary ammunition for the company to rapidly capture the market in the future. Sustained and stable R&D investment ensures that Ocumension can steadily advance various R&D projects around its core product lines. During the reporting period, the allergic conjunctivitis drug OT-1001 (Cetirizine Hydrochloride Eye Drops) is expected to receive marketing approval soon; OT-101 (0.01% Atropine Sulfate Eye Drops) is progressing rapidly, with the first global patient in the Phase III MRCT having completed three years of treatment; OT-502 (Dexamethasone Implant) completed Phase III clinical trials and will soon submit an NDA; and the self-developed Class 1 new drug OT-202 (Spleen Tyrosine Kinase Inhibitor) for the treatment of dry eye syndrome completed Phase II clinical trials, achieving primary endpoints. In addition, OT-702 (Aflibercept Biosimilar) has completed Phase III clinical trials with positive results, and the NDA has been submitted to and accepted by the CDE. As an important component of Ocumension's commercialization strategy, OT-702 will effectively fill the gap in the company's portfolio for anti-VEGF drugs targeting retinal diseases. Leveraging the company's strong ophthalmic platform and extensive commercialization channels, this high-quality drug will be made available to more patients with retinal diseases. It is understood that the outstanding performance of anti-VEGF drugs in the treatment of retinal diseases has opened up a billion-dollar ophthalmic market. As more new ophthalmic drugs are developed in the future, the potential for market growth remains enormous. Currently, the company owns 25 drug assets targeting the anterior and posterior segments of the eye, including three products in Phase III clinical trials and three products in the registration phase for marketing approval. Ocumension remains one of the innovative pharmaceutical companies with the most products in Phase III clinical trials and the registration phase for marketing approval in the Chinese ophthalmic drug market. According to industry professionals, the company's continuous increase in R&D investment is a strong indicator of its profitability and demonstrates the company's strategic determination to drive development through innovation. By actively laying out product pipelines in niche areas and developing innovative drugs, the company is establishing a solid foundation for product line expansion and core product cultivation, contributing to its long-term sustainable development. Booming Ophthalmic Market Continues to Unleash Potential In recent years, the ophthalmic sector, as a representative of non-oncological fields, has attracted increasing interest from various companies. Pharmaceutical giants have been entering the ophthalmic sector one after another. In December 2023, Johnson & Johnson acquired a gene therapy for X-linked retinitis pigmentosa (XLRP) from MeiraGTx in a transaction valued at $415 million; in November 2023, AbbVie reached an agreement with Aldeyra, acquiring exclusive rights to the new dry eye disease drug Reproxalap for $401 million; in April 2023, Astellas invested $5.9 billion to acquire Iveric Bio, gaining access to a new drug for geographic atrophy, avacincaptad pegol; and at the end of 2022, Amgen acquired Horizon, securing Tepezza, a new drug for thyroid eye disease... Pharmaceutical giants have recognized the current transformation in the ophthalmic market's scale and structure, driven by the emergence of innovative technologies. As the aging population and widespread use of electronic devices increase the incidence of various eye diseases, Frost & Sullivan predicts that the global ophthalmic drug market will reach $46.4 billion by 2025 and $73.9 billion by 2030. In the future, as more clinical needs for ophthalmic diseases are explored and met, the market is poised for further explosive growth in various sub-segments. SOURCE OcuMension