PL-9643

Advancing differentiated MC4R-based obesity programs into clinical development Melanocortin-based obesity therapies targeting rare MC4R pathway disorders with a primary focus on hypothalamic obesity and Prader-Willi syndrome Oral small-molecule MC4R agonist PL7737 progressing through IND-enabling toxicology studies, with IND submission and clinical trial initiation planned for the first half of 2026 Next-generation selective peptide MC4R agonists d esigned for once-weekly subcutaneous dosing, with IND submission and clinical trial initiation planned for the second half of 2026 Executed sublicensing of MC1R agonist PL9643 in January 2026, sharpening focus on core obesity portfolio while preserving upside Received $3.8 million in upfront consideration Eligible for future milestone payments and royalties Strengthened balance sheet through successful public financing Completed an $18.2 million public offering, including the full exercise of the over-allotment option, on November 12, 2025 Restored NYSE American listing compliance and trading, re-establishing market visibility and liquidity Teleconference and webcast to be held on February 17, 2026 at 11:00 AM ET PRINCETON, N.J. , Feb. 17, 2026 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor (MCR) system, today announced financial results for its fiscal second quarter ended December 31, 2025, and provided a corporate update. "Palatin continues to advance its MC4R-based obesity pipeline, with our oral small-molecule MC4R agonist, PL7737, on track to enter clinical evaluation in the first half of this year, and a long-acting peptide MC4R agonist expected to initiate clinical development in the second half of the year," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin Technologies. "As we progress these programs, we remain focused on delivering differentiated product profiles designed to enhance patient tolerability, including the potential for reduced gastrointestinal side effects, while minimizing off-target effects such as hyperpigmentation. Our preclinical data support the potential applicability of this approach across both rare and select broader obesity indications, with a particular emphasis on neuroendocrine disorders, including hypothalamic obesity and Prader-Willi syndrome. This focus underscores the differentiated nature of our melanocortin platform and our commitment to addressing areas of significant unmet medical need." "We delivered meaningful execution across our core strategic priorities, highlighted by the successful completion of our $18.2 million public offering, the resumption of trading of our common stock on the NYSE American, and the sublicensing of PL9643, an MC1R agonist Phase 3 asset for dry eye disease," continued Dr. Spana. "Entering 2026, Palatin is positioned with a strengthened balance sheet, multiple partnerships supported by defined near-term milestones, and a focused and differentiated obesity pipeline that provides a clear path toward sustainable, long-term value creation." Obesity Program Update The obesity program is focused on developing differentiated MC4R agonists designed to enhance patient tolerability, including the potential for reduced gastrointestinal side effects, while minimizing off-target effects such as hyperpigmentation. Planned clinical studies are expected to enroll and evaluate patients with hypothalamic obesity and Prader-Willi syndrome, addressing populations with significant unmet medical need. PL7737 (oral MC4R agonist): Demonstrated meaningful weight loss, oral bioavailability across relevant preclinical models. IND-enabling toxicology studies are progressing as planned, with an IND submission and initiation of a Phase 1 single- and multiple-ascending dose (SAD/MAD) trial anticipated in the first half of 2026. Next-generation selective peptide MC4R agonists: Designed for once-weekly subcutaneous dosing, with an IND submission and initiation of a Phase 1 SAD/MAD trial targeted for the second half of 2026. Out-Licensing Programs Update Retinal diseases (MCR agonists) – Collaboration with Boehringer Ingelheim, providing near-term non-dilutive capital and substantial downstream value potential. Received an upfront payment of €2.0 million ($2.3 million) in August 2025. Achieved €5.5 million ($6.5 million) research milestone in September 2025, reflecting continued program progress. Eligible to receive up to €12.5 million ($14.5 million) in additional near-term research milestones and up to €260 million ($307.0 million) in development, regulatory, and commercial milestones, in addition to tiered royalties on net sales. PL9643 (MC1R agonist) - Dry Eye Disease – Sublicensing agreement with Altanispac Labs, providing near-term value, while preserving long-term participation. Received $3.8 million in upfront consideration in January 2026, strengthening the Company's balance sheet. Eligible to receive additional future payments under the sublicensing agreement, including asset disposition and commercialization milestones, as well as royalties on net sales. PL8177 (MCR agonist) - Ulcerative Colitis, advancing toward strategic partnering following clinical validation. Delivered positive Phase 2 proof-of-concept results, supporting the therapeutic potential of the program. Active out-licensing discussions are underway, reflecting interest from potential partners in the asset's clinical pro commercial potential. Diabetic nephropathy (MCR agonists) - Building on encouraging clinical data to advance partnering opportunities. Reported positive Phase 2 open-label results, supporting the therapeutic potential of the program. Ongoing out-licensing discussions continue to explore strategic pathways to maximize the value of the asset. Corporate Update Public Offering On November 12, 2025, Palatin announced the closing of its upsized $18.2 million underwritten public offering ("Offering"), including the full exercise of the over-allotment option, consisting of 2,795,384 shares of common stock (or pre-funded warrants in lieu thereof) of the Company, together with Series J warrants to purchase up to 2,795,384 shares of common stock (or pre-funded warrants in lieu thereof), (the "Series J Warrants"), and Series K warrants to purchase up to 2,795,384 shares of common stock (or pre-funded warrants in lieu thereof), (the "Series K Warrants"), at a combined public offering price of $6.50 per share of common stock and accompanying Series J and Series K warrants (the "Offering"). Each Series J Warrant has an exercise price of $6.50 per share and will expire on the earlier of (i) the eighteen-month anniversary of the original issuance date or (ii) on the 31st calendar day following the date that the Company receives the U.S. Food and Drug Administration ("FDA") acceptance of the Company's Investigational New Drug for an in-house obesity treatment compound (oral small molecule or long-acting peptide) (the "FDA Exercise Period"). Each Series K Warrant has an exercise price of $8.125 per share and will expire on the five-year anniversary of the original issuance date, however, if a holder's Series J Warrants have not been terminated in accordance with their terms prior to the expiration of the FDA Exercise Period, such holder's Series K Warrants will automatically terminate. The gross proceeds from the Offering, before deducting the underwriting discounts and commissions and offering expenses, were approximately $18.2 million, with net proceeds amounting to $16.9 million. The Company may receive additional proceeds of up to $18.2 million upon the cash exercise of the milestone related Series J Warrants, however, there is no guarantee that such warrants will be exercised and accordingly that the Company will receive any proceeds from the exercise thereof. The Company intends to use the net proceeds from the Offering to support the development of its obesity program and for working capital and general corporate purposes. NYSE American As a result of the closing of the Offering, the Company regained compliance with NYSE American continued listing standard of the NYSE American Company Guide and all applicable requirements for continued listing on NYSE American. Effective November 12, 2025, the Company's common stock resumed trading on the NYSE American under the symbol "PTN." Fiscal Second Quarter Ended December 31, 2025, Financial Results Revenue For the second quarter ended December 31, 2025, Palatin recognized $116,036 in collaboration and license revenue compared to $0 for the comparable quarter last year. The increase in collaboration and license revenue is related to the Boehringer Ingelheim agreement which consisted of certain cost related reimbursements. Operating Expenses Total operating expenses were $7.4 million for the second quarter ended December 31, 2025, compared to $2.6 million for the comparable quarter last year. The increase in operating expenses was mainly due to the gain on the sale of Vyleesi recorded in the quarter ended December 31, 2024, which resulted in a decrease in net operating expenses, and an increase in operating expenses for the quarter ended December 31, 2025, consisting of an increase in costs on our MCR obesity development programs and higher compensation costs and professional fees. Other Income / (Expense) Total other income (expense), net was $64,687 for the second quarter ended December 31, 2025, compared to $168,841 for the comparable quarter last year. The decrease was a result of a decrease in investment income and foreign currency translation gain, offset by a decrease in interest expense incurred during the second quarter ended December 31, 2025. Cash Flows Palatin's net cash used in operations was $4.8 million for the second quarter ended December 31, 2025, and for comparable quarter last year. Net Loss Palatin reported a net loss for the second quarter ended December 31, 2025, of $7.3 million, or $(2.86) per basic and diluted common share, compared to a net loss of $2.4 million, or $(5.92) per basic and diluted common share, for the comparable quarter last year. Cash Position As of December 31, 2025, Palatin's cash and cash equivalents were $14.5 million, compared to cash and cash equivalents of $1.3 million at September 30, 2025, and $2.6 million as of June 30, 2025. Palatin currently expects a cash runway beyond the quarter ending March 31, 2027. In January 2026, as partial consideration for the rights to PL9643, the sublicensing agreement provided for upfront consideration in the form of non-cash debt cancellation of approximately $3,800,000, which is reflected in the Company's current liabilities as of December 31, 2025. The $3,800,000 million will be recognized as license revenue in the Consolidated Statements of Operations for the quarter ending March 31, 2026. Conference Call / Webcast Palatin will host a conference call and audio webcast on February 17, 2026, at 11:00 a.m. ET to discuss the results of operations in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-888-506-0062 (US) or 1-973-528-0011 (International), Participant Access Code: 967781. The audio webcast and replay can be accessed by logging on to the "Investor-Webcasts" section of Palatin's website at A telephone and audio webcast replay will be available one hour after the completion of the call. To access the telephone replay, dial 1-877-481-4010 (US) or 1-919-882-2331 (International), Replay Passcode 83633. The webcast and telephone replay will be available through March 3, 2026. Melanocortin-4 Receptor Agonists Effect on Obesity Hypothalamic neurons expressing the melanocortin-4 receptor (MC4R) play a central role in regulating stored energy, food intake, and body weight. Genetic mutations that inhibit signaling through the MC4R pathway lead to hyperphagia, decreased energy expenditure and early-onset obesity; such mutations have been identified as the cause of several rare genetic obesity disorders. MC4R agonism represents an attractive target for potential obesity treatments. About Hypothalamic Obesity Hypothalamic obesity is a rare and severe form of obesity caused by dysfunction or damage to the hypothalamus, the region of the brain that regulates appetite, satiety, and energy balance. Hypothalamic obesity can occur as an acquired condition, most commonly after surgery or radiation therapy for brain tumors such as craniopharyngioma, or as a congenital disorder associated with genetic syndromes and developmental abnormalities affecting hypothalamic function. Individuals with hypothalamic obesity typically experience rapid, excessive weight gain, uncontrollable hunger, and profound metabolic disturbances that are resistant to conventional diet, exercise, and behavioral interventions. There are currently no approved pharmacologic treatments specifically indicated for hypothalamic obesity, representing a significant unmet medical need. About Prader-Willi Syndrome Prader-Willi syndrome (PWS) is a rare, complex genetic neurodevelopmental disorder caused by the loss of function of specific genes on chromosome 15. The condition is characterized by hyperphagia, impaired satiety, developmental delays, reduced muscle tone, endocrine abnormalities, and behavioral challenges. Individuals with PWS typically develop an intense and persistent drive to eat, beginning in early childhood, which can lead to severe obesity and related metabolic complications if not strictly managed. Current treatment approaches focus primarily on symptom management, including nutritional supervision, behavioral interventions, and growth hormone therapy, but there are no approved pharmacologic therapies that directly address hyperphagia or the underlying hypothalamic dysfunction associated with PWS. As a result, PWS represents a significant unmet medical need. About Melanocortin Receptor Agonists The melanocortin receptor ("MCR") system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MC1R through MC5R. Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects. About Palatin Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential. For more information, visit the company's website at and follow us on X (formally Twitter) @PalatinTech. Forward-looking Statements Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about Palatin products in development, clinical trial results, potential actions by regulatory agencies, regulatory plans, development programs, proposed indications for product candidates, and market potential for product candidates are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin's actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions by the FDA and other regulatory and the need for regulatory approvals, Palatin's ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin's products, and other factors discussed in Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating events that occur after the date of this press release. Palatin Technologies ® is a registered trademark of Palatin Technologies, Inc. PALATIN TECHNOLOGIES, INC. and Subsidiary Consolidated Statements of Operations (unaudited) Three Months Ended December 31, Six Months Ended December 31, 2025 2024 2025 2024 REVENUES Collaboration and license $ 116,036 $ - $ 8,963,586 $ - OPERATING EXPENSES Research and development 4,319,767 3,429,479 6,845,533 9,173,233 General and administrative 3,124,817 1,681,844 4,785,548 3,702,775 Gain on sale of Vyleesi - (2,500,000) - (2,500,000) Total operating expenses 7,444,584 2,611,323 11,631,081 10,376,008 Loss from operations (7,328,548) (2,611,323) (2,667,495) (10,376,008) OTHER INCOME (EXPENSE) Investment income 65,185 29,044 83,668 107,620 Foreign currency transaction gain - 143,600 - 12,000 Interest expense (498) (3,803) (2,500) (9,743) Total other income (expense), net 64,687 168,841 81,168 109,877 NET LOSS $ (7,263,861) $ (2,442,482) $ (2,586,327) $ (10,266,131) Basic and diluted net loss per common share $ (2.86) $ (5.92) $ (1.47) $ (25.36) Weighted average number of common shares outstanding used in computing basic and diluted net loss per common share 2,539,632 412,697 1,755,641 404,799 PALATIN TECHNOLOGIES, INC . and Subsidiary Consolidated Balance Sheets (unaudited) December 31, 2025 June 30, 2025 ASSETS Current assets: Cash and cash equivalents $ 14,476,162 $ 2,564,265 Accounts Receivable 1,636,325 - Other receivables - 29,468 Prepaid expenses and other current assets 1,354,992 325,695 Total current assets 17,467,479 2,919,428 Property and equipment, net 113,485 129,444 Right-of-use assets - operating leases 346,764 161,166 Other assets - 56,916 Total assets $ 17,927,728 $ 3,266,954 LIABILITIES AND STOCKHOLDERS' DEFICIENCY Current liabilities: Accounts payable $ 5,453,080 $ 6,998,806 Accrued expenses 659,841 881,412 Short-term operating lease liabilities 219,727 129,812 Total current liabilities 6,332,648 8,010,030 Long-term operating lease liabilities 129,061 33,969 Total liabilities 6,461,709 8,043,999 Stockholders' equity (deficiency): Preferred stock of $0.01 par value – authorized 10,000,000 shares: shares issued and outstanding designated as follows: Series A Convertible: authorized 4,030 shares as of December 31, 2025: issued and outstanding 4,030 shares as of December 31, 2025 and June 30, 2025 40 40 Series D Convertible: authorized 3,400 shares as of December 31, 2025: issued and outstanding 3,400 shares as of December 31, 2025 and June 30, 2025 34 34 Common stock of $0.01 par value – authorized 300,000,000 shares: issued and outstanding 1,757,199 shares as of December 31, 2025 and 929,597 shares as of June 30, 2025 17,572 9,296 Additional paid-in capital 473,108,599 454,287,484 Accumulated deficit (461,660,226) (459,073,899) Total stockholders' equity (deficiency) 11,466,019 (4,777,045) Total liabilities and stockholders' equity (deficiency) $ 17,927,728 $ 3,266,954 View original content to download multimedia: SOURCE Palatin Technologies, Inc.

2025年是干眼症研究与治疗领域承前启后、硕果累累的一年。以首个神经调节剂TRYPYR®的获批和新型RASP抑制剂Reproxalap的上市为标志，干眼症治疗正式迈入了靶向多元化和机制创新的新阶段。与此同时，Miebo™、VEVYE™等近年来获批的特色疗法在真实世界中证明了其独特的临床价值，极大地丰富了医生的治疗武器库。 1 干眼症的复杂性与未满足的临床需求 干眼症是一种复杂的、异质性的疾病，其核心病理机制涉及泪膜不稳定、泪液高渗透压、眼表炎症与损伤，以及神经感觉异。传统上，干眼症被分为两大类：水液缺乏型和蒸发过强型。然而，绝大多数患者表现为两种类型的混合型。这种病因的复杂性和临床表现的多样性，给干眼症的诊断和治疗带来了巨大挑战。 尽管市场上已有多种治疗药物，如人工泪液、抗炎药物以及各种物理治疗设备，但临床上仍存在巨大的未满足需求。许多患者对现有疗法反应不佳，或者无法耐受其副作用，如刺痛感、味觉障碍等。此外，现有治疗多为对症处理，难以从根本上解决所有潜在的病理机制，特别是针对神经损伤修复、腺体功能再生等方面的治疗手段尤为缺乏。 2 干眼症治疗新格局：获批的药物与设备 2.1 重磅获批药物：开启神经调节新纪元 2.1.1 TRYPYR® (Acolitremon) 滴眼液：首个TRPM8受体激动剂 Alcon公司的TRYPYR®(acolitremon)滴眼液于5月至6月期间获批，用于治疗干眼症的体征和症状。这是一款同类首创（first-in-class）的药物，其获批标志着干眼症治疗策略从传统的抗炎和润滑，正式扩展到了神经调节领域。 产品名称： TRYPYR® (acolitremon) 滴眼液 活性成分： Acolitremon 作用机制（MOA）： Acolitremon是一种选择性的瞬时受体电位M8（TRPM8）激动剂。TRPM8通道是位于角膜和结膜冷感受器神经末梢的离子通道，在感知眼表冷却和维持基础泪液分泌中起着关键作用。通过激活TRPM8通道，TRYPYR®能够模拟眼表冷却的感觉，从而通过神经反射弧刺激三叉神经传出通路，促进泪腺和杯状细胞分泌内源性的、成分完整的自然泪液。这种“按需”促进自然泪液分泌的机制，与传统的人工泪液替代疗法有着本质区别。 适应症： 用于治疗干眼症的体征与症状。 批准机构： 美国食品药品监督管理局（FDA）。 TRYPYR®的获批是基于其在临床试验中的表现。临床数据显示，该药物能快速、显著地改善患者的眼部干涩症状，并增加泪液分泌量。其独特的神经调节机制为患者提供了全新的选择。 2.1.2 Reproxalap 滴眼液：靶向炎症的“上游开关” 紧随TRYPYR®之后，Aldeyra Therapeutics公司的Reproxalap在2025年底也迎来了其关键的监管节点。FDA对其新药申请（NDA）设定的《处方药使用者付费法案》（PDUFA）目标审查日期为2025年底。如Reproxalap获批后，成为干眼症治疗领域的又一重要突破。 产品名称： Reproxalap 活性成分： Reproxalap 作用机制（MOA）： Reproxalap是一种新型、首创的小分子活性醛类物质（RASP）抑制剂。RASP是一类亲电子的炎症介质，位于炎症级联反应的“上游”，其水平在眼部和全身性炎症性疾病中升高。通过共价结合并抑制RASP，Reproxalap能够降低炎症细胞因子的活性，从而发挥广谱的抗炎作用。与现有抗炎药（如环孢素、利替格拉斯特）靶向免疫细胞（T细胞）的“下游”通路不同，Reproxalap通过抑制更上游的RASP，提供更快速、更广泛的抗炎效果。 适应症： 用于治疗干眼症的体征与症状。 批准机构： 美国食品药品监督管理局（FDA）（待最终确认）。 临床试验数据显示，Reproxalap起效迅速，能够在用药后数分钟内显著改善患者的眼部干涩评分和发红体征。这一特性对于追求快速症状缓解的患者极具吸引力。它的上市将为干眼症的抗炎治疗提供一个作用机制全新的强力工具。 2.2 近期获批产品在2025年的临床应用与地位 一些在2023-2024年获批的创新疗法在2025年得到了更广泛的临床应用，其在真实世界中的疗效和安全性数据也日益丰富。 2.2.1 Miebo™ (Perfluorohexyloctane, 全氟己基辛烷) 滴眼液 于2023年获得FDA批准的Miebo™，是首个专门用于抑制泪液蒸发的药物。 技术原理： Miebo是一种不含水、不含防腐剂的半氟代烷烃。其作用机制非常独特：滴入眼中后，它会在泪膜表面形成一层单分子层，模拟并增强天然泪膜脂质层的功能，从而显著减少泪液的蒸发。这对于占比高达86%的蒸发过强型干眼症（主要是MGD）患者具有直接的治疗意义。 2025年临床定位： 在2025年，Miebo已成为治疗MGD相关干眼症的核心药物之一。它不直接参与抗炎或免疫调节，而是从物理机制上稳定泪膜，因此可以与现有的抗炎药物（如Xiidra®、Cequa®）联合使用，形成“抗炎+抗蒸发”的互补治疗方案。2025年的临床实践和患者反馈显示，对于那些在使用免疫抑制剂后症状仍有残留的MGD患者，联用Miebo可以获得更好的症状控制和泪膜稳定性。 2.2.2 VEVYE™ (CyclASol®, 0.1% 环孢素眼用溶液) 于2023年获批的VEVYE™，虽然其活性成分仍是环孢素，但其创新的药物递送技术使其在众多环孢素产品中脱颖而出。 技术原理： VEVYE™采用了Novaliq公司的EyeSol®无水递送技术。该技术使用一种新颖的辅料，能够在不含水、表面活性剂或防腐剂的情况下，将环孢素高效地递送至眼表。这种无水配方不仅提高了药物的生物利用度和在眼表的停留时间，还极大地改善了患者的用药舒适度，显著减少了传统环孢素制剂常见的刺痛和烧灼感。 2025年临床定位： 凭借其出色的耐受性和高效递送，VEVYE™在2025年成为许多初次使用或无法耐受其他环孢素制剂患者的首选。对于需要长期抗炎治疗的患者，更好的舒适度意味着更高的用药依从性，从而确保了长期的治疗效果。它与Cequa®（同样是0.09%环孢素，但采用纳米胶束技术）共同构成了新一代高效、舒适的环孢素治疗选择。 2.2.3 LACRIFILL® 泪道凝胶 于2024年获批的LACRIFILL®是一种创新的泪道栓塞装置，为水液缺乏型干眼症提供了长效的解决方案。 技术原理： LACRIFILL®是一种由羟丙甲纤维素和甘油制成的、可吸收的临时性泪道凝胶。通过注射器将其注入泪小管后，它会形成一个柔软、有弹性的凝胶状栓子，阻塞泪液的排出通道。这可以显著增加眼表的泪液存留量和存留时间。与传统的固体硅胶泪道栓不同，LACRIFILL®在6个月左右会逐渐被吸收溶解，避免了永久性栓塞可能带来的并发症，如栓子脱落、感染或肉芽肿形成。 2025年临床定位： 作为一种微创、长效的治疗手段，LACRIFILL®在2025年被广泛应用于中重度水液缺乏型干眼症患者。特别是对于那些频繁使用人工泪液但效果不佳，或希望减少滴眼次数的患者，它提供了一个便捷且高效的选择。 2.3 设备类疗法：稳步发展与技术迭代 干眼症的物理治疗设备在2025年虽然没有颠覆性的全新平台获批，但现有技术在临床应用、方案优化和设备迭代方面取得了稳步进展。这些设备主要针对MGD，通过物理能量疏通堵塞的睑板腺，恢复其正常的脂质分泌功能。 强脉冲光（IPL）： IPL技术在2025年成为MGD治疗的主流选择之一。Lumenis等公司的IPL设备在2022年左右获得了FDA针对干眼症适应症的批准。2025年的发展重点在于治疗方案的精细化。临床医生也更多地将IPL与其他疗法结合，形成综合治疗方案。 热脉动系统： 以LipiFlow®、TearCare®、iLux®等为代表的热脉动系统，通过对眼睑内外同时加热和按摩，高效地融化并排出堵塞的睑酯。2025年，这些设备的更新换代主要体现在提升患者舒适度、缩短治疗时间以及更智能化的能量控制上。例如，Systane® iLux2®系统提供了更便携和可视化的操作体验。 低强度光疗（LLLT）： 作为一种较新的物理疗法，LLLT通过特定波长的光照射眼睑周围皮肤，利用光生物调节作用减轻炎症、促进细胞修复和改善腺体功能。虽然其在美国的应用仍在起步阶段，但在其他地区，LLLT已获得批准并被纳入临床实践，显示出良好的应用前景。 热致焕肤技术（TMA）： 如Novoxel公司的Tixel i设备，于2024年底获得应用许可，用于治疗蒸发性干眼。它通过纯热能对眼睑皮肤进行非烧蚀性处理，刺激胶原蛋白新生和改善皮肤质地，从而间接改善睑板腺功能。这是2025年值得关注的一项新兴设备技术。 总而言之，2025年的干眼症治疗工具箱得到了极大的丰富。 3 临床反馈与真实世界证据：新疗法的实践检验 随机对照试验（RCT）是评估药物疗效和安全性的金标准，但其严格的入组/排除标准和高度受控的环境，有时无法完全反映药物在复杂多样的真实临床环境中的表现。因此，真实世界证据（RWE）对于全面理解新疗法的价值至关重要。2025年，随着多款新疗法进入市场，关于它们的真实世界研究和临床反馈也陆续涌现。 3.1 LACRIFILL® 泪道凝胶：高患者满意度与便捷性 作为一种在2024年获批的微创治疗手段，LACRIFILL®在2025年获得了大量积极的患者反馈。 极高的患者满意度： 2025年2月发布的一项患者体验调查显示，LACRIFILL®的整体满意度非常高。在一项调查中，高达98%的患者表示他们会再次使用该疗法。另一项调查显示，92.72%的患者是基于医生或验光师的推荐选择了LACRIFILL®治疗，这反映了临床医生对其疗效和安全性的高度认可。 治疗过程的高度易用性： 患者普遍反映，LACRIFILL®的植入过程“非常容易”或“容易”，几乎没有不适感。这种无痛、快速的诊室内操作体验，大大降低了患者接受治疗的门槛。 显著的症状缓解： 患者积极评价其在减少人工泪液使用频率、缓解眼部干涩、烧灼感等方面的效果。这些积极的真实世界反馈，巩固了LACRIFILL®作为中重度水液缺乏型干眼症一线或二线治疗选择的地位。 3.2 新一代抗炎药：耐受性与依从性的改善 Lifitegrast (Xiidra®) 的真实世界经验： 虽然Xiidra®已上市多年，但2025年发表的真实世界研究为了解其在长期使用中的表现提供了新视角。一项研究评估了患者对其症状缓解的满意度，结果显示，患者对Xiidra®在改善瘙痒、干涩和烧灼感等方面的满意度为中等到高。研究还发现，Xiidra®在伴有隐形眼镜佩戴不适的干眼患者中应用广泛。然而，味觉障碍仍然是影响部分患者依从性的主要不良反应。这些数据为新上市的抗炎药Reproxalap提供了参照基准。 VEVYE™ (CyclASol®) 的临床优势： VEVYE™凭借其无水配方，在真实世界中展现了其在耐受性方面的巨大优势。2025年的临床反馈普遍指出，与传统的环孢素乳剂相比，使用VEVYE™的患者报告的刺痛、烧灼感等用药部位不适发生率显著降低。这种“舒适的抗炎治疗”体验，使得患者，尤其是那些对药物刺激敏感的患者，能够更好地坚持长期治疗，从而确保了抗炎效果的稳定发挥。 3.3 Miebo™ (Perfluorohexyloctane)：抗蒸发治疗的真实价值 Miebo™作为首个抗蒸发药物，其在真实世界中的应用数据备受关注。2025年的一些研究开始评估其治疗满意度。例如，一项研究使用视觉模拟量表（VAS）来评估患者的治疗满意度，结果显示，使用Miebo™的患者报告了较高的满意度评分。临床医生反馈，对于MGD患者，尤其是在接受了IPL或热脉动治疗后，每日使用Miebo™作为长期维持治疗，能够有效稳定泪膜，减少症状的复发。此外，由于其不含防腐剂且作用机制独特，与其他药物的相互作用风险低，使其成为联合治疗方案中的理想“搭档”。 3.4 TRYPTYR® (Acolitremon)：神经调节疗法的初步反馈 作为2025年年中才获批的药物，关于TRYPTYR®的大规模真实世界数据尚在积累中。然而，基于其临床试验数据和早期的市场反馈，可以总结出以下几点： 安全性与耐受性： 临床试验显示其安全性良好，最常见的副作用是轻微的用药部位不适或疼痛，这在滴眼液中较为常见，且通常是暂时的。与免疫抑制剂可能带来的全身性影响或Xiidra®的味觉障碍相比，其安全性特征具有一定优势。 快速起效的潜力 临床定位探索： 在2025年底，临床医生正在积极探索TRYPTYR®的最佳应用场景。它可能特别适用于：（1）对传统抗炎药反应不佳的患者；（2）以神经感觉异常为主要特征的干眼患者；（3）需要快速、间歇性缓解症状的患者。 3.5 物理治疗的患者报告结果 2025年的数据继续证实物理治疗在改善患者生活质量方面的价值。这些数据强调了针对MGD这一核心病因进行物理干预的重要性。 3.6 真实世界证据的重要性与未来 2025年的趋势清晰地表明，RWE在药物和疗法的整个生命周期中扮演着越来越重要的角色。监管机构、支付方和临床医生都愈发重视RWE在验证临床试验结果、发现罕见不良事件、评估长期疗效和成本效益方面的重要价值。 4 研发管线与未来希望：2025年在研项目深度剖析 干眼症领域的研发管线在2025年依然异常活跃，众多处于不同临床阶段的候选药物预示着未来几年治疗选择将更加丰富和多样化。据统计，截至2025年3月，全球有大约80项针对干眼症的临床试验正在进行中，涵盖了从I期到III期的各个阶段。这些在研项目不仅包括对现有机制的改进，更涌现出大量针对全新靶点和通路的前沿疗法。 4.1 免疫调节与抗炎新靶点 抗炎仍然是干眼症药物研发的主流方向，但研究者们正在探索比现有T细胞抑制剂更精准、更多样化的靶点。 4.1.1 SHR8058 滴眼液 (恒瑞医药) 研发进展： 2025年，恒瑞医药的SHR8058滴眼液的上市许可申请已获得中国国家药品监督管理局（NMPA）药品审评中心（CDE）的受理，用于治疗MGD相关的干眼病。这预示着中国本土研发的干眼症创新药即将进入市场，对于满足中国庞大的患者需求具有重要意义。 4.1.2 HBM9036 (Tanfanercept, 和铂医药) 研发进展： HBM9036目前正处于III期临床试验阶段，用于治疗中重度干眼症。局部给药的HBM9036旨在提供靶向性的眼表抗炎效果，同时避免全身性副作用。OCS-02（Oculis公司）是另一款处于研发后期的局部抗TNF-α疗法。 4.1.3 GRF312 (Grifols) 研发进展： 2025年第三季度，Grifols公司启动了GRF312的II期临床试验。这代表了一种全新的治疗思路，即利用血浆衍生产品的天然免疫调节能力来治疗干眼症。 4.2 神经生长与修复 神经感觉异常，特别是角膜神经的损伤和功能障碍，被认为是干眼症，尤其是疼痛性干眼症的核心机制之一。因此，促进神经再生和修复的疗法备受期待。 4.2.1 SMR001 (山东衍渡生物) 作用机制： 一种重组人神经生长因子（rhNGF）滴眼液。NGF是一种神经营养因子，对于角膜神经的存活、生长和功能维持至关重要。通过外源性补充NGF，SMR001旨在修复受损的角膜神经，恢复角膜知觉，并可能通过改善神经营养来促进眼表上皮的愈合。 研发进展： 2025年，由ST未名旗下山东衍渡生物研发的SMR001已获得在中国进行III期临床试验的批准。 4.3 促进泪膜稳态与腺体功能 针对泪膜的各个组成部分——脂质层、水液层和黏蛋白层——进行修复和增强，是另一个重要的研发方向。 4.3.1 AZR-MD-001 (Azura Ophthalmics) 作用机制： 一种角蛋白溶解剂。其创新之处在于，它旨在通过溶解堵塞在睑板腺开口处的过度角化的上皮和角蛋白，从根本上疏通腺体管道，恢复睑酯的正常排出。 研发进展： 该药物正处于临床开发后期，用于治疗MGD。 4.3.2 PL9643 (Bremelanotide, Palatin Technologies) 作用机制： 一种黑皮质素激动剂，通过激活眼表的黑皮质素受体，发挥多重有益作用，包括抗炎、促进上皮愈合和调节泪液分泌。 研发进展： 2025年5月，Palatin公司公布了其关键性III期临床试验（MELODY-1）的积极顶线结果。数据显示PL9643在多个干眼症体征和症状终点上均显示出统计学意义的改善。 4.3.3 Lacripep (TearSolutions) 作用机制： Lacripep是人泪腺蛋白Lacritin的一种合成肽段片段。天然的Lacritin能够促进基础泪液分泌、维持眼表细胞健康和促进上皮修复。干眼症患者泪液中Lacritin水平下降，而Lacripep旨在通过外源性补充这种关键的功能性蛋白，恢复眼表的自然稳态。 研发进展： Lacripep已完成II期临床试验，显示出改善眼表体征和症状的潜力。它代表了“修复与再生”的治疗理念，即补充内源性缺失的关键生物分子来恢复眼表健康。 4.4 新兴机制与前沿探索 除了上述主流方向，一些更具前瞻性的疗法也在2025年崭露头角。 4.4.1 ST-100 (Stuart Therapeutics) 作用机制： 一种胶原蛋白模拟肽。它能靶向并结合到受损的细胞外基质，从而促进组织修复和愈合，可能对角膜上皮损伤和基底膜修复有益。 研发进展： ST-100正处于早期临床开发阶段。其独特的“靶向修复”机制为治疗与眼表损伤相关的干眼症提供了新思路。 4.5 临床试验终点的演变 值得注意的是，2025年的干眼症临床试验在终点选择上也呈现出新的趋势。除了传统的客观体征（如角膜荧光素染色评分、Schirmer测试、TBUT）和主观症状（如OSDI评分）外，越来越多的试验开始纳入更能反映患者真实感受和生活质量的终点，如视觉功能、阅读速度、减少使用人工泪液的频率等。FDA在2025年发布的干眼症药物开发行业指导草案也鼓励开发者探索和验证新的、更有意义的临床终点。 5 局限与挑战：2025年干眼症诊疗的未解难题 从诊断到长期管理的整个链条上，干眼症治疗依然存在着诸多根深蒂固的挑战和局限性。 5.1 诊断困境：生物标志物的缺失与“症”“体”分离 干眼症诊断是目前临床实践中的最大痛点之一。 缺乏可靠的生物标志物： 这是业内公认的核心挑战。截至2025年，仍然没有一个被广泛接受和验证的、能够用于干眼症诊断、分型或预后判断的生物标志物，这极大地限制了精准诊断和个性化治疗的发展。 症状与体征的不一致性： 干眼症临床上一个常见的棘手问题是“症”“体”分离。这种现象的背后可能涉及复杂的神经病理性疼痛机制、心理因素以及中枢敏化等，使得仅依赖传统体征或症状问卷进行诊断和疗效评估变得不可靠。 诊断标准的异质性： 全球范围内，对于干眼症的诊断标准尚未完全统一。不同的临床中心或研究可能采用不同的诊断流程和阈值，这不仅给临床实践带来困惑，也使得不同研究结果之间的横向比较变得困难。 5.2 治疗瓶颈：患者依从性、成本与疗效天花板 患者依从性差：  2025年的临床实践依然面临这一难题。导致依从性差的原因是多方面的： A. 药物副作用 B. 治疗方案复杂 C. 起效缓慢 D. 治疗成本高昂 现有疗法的“天花板”效应： 尽管新药层出不穷，但对于部分难治性干眼症患者，现有所有疗法（包括药物和物理治疗）的效果都有限。这表明我们对这些患者的核心病理机制可能仍未完全理解，或者需要全新的治疗策略，如再生医学或基因疗法。 临床医生的治疗信心与知识差距： 一些调查显示，部分眼科医生对治疗干眼症的信心并不高，可能因为对新疗法的认知不足，或受限于保险报销政策，而不愿或无法为患者提供最合适的治疗方案。加强对临床医生的继续教育至关重要。 5.3 研发与监管挑战：高昂的失败风险 复杂的监管路径： 由于疾病的异质性和缺乏金标准终点，监管机构（如FDA）通常要求提供来自至少两个独立的、设计良好的大型临床试验的稳健证据，才能批准上市。这大大增加了研发的成本和时间。 临床试验中的高安慰剂效应： 干眼症临床试验中，安慰剂组的症状和体征也常常出现显著改善，即所谓的“高安慰剂效应”。这使得证明候选药物优于安慰剂的统计学差异变得非常困难，是导致许多有潜力的药物在后期临床试验中失败的主要原因之一。 从基础研究到临床转化的鸿沟 6 前沿展望：未来技术与发展趋势 6.1 再生医学：从“管理”到“治愈”的希望 再生医学旨在修复或替换受损的组织和器官，为从根本上治愈干眼症带来了希望。 干细胞疗法： 利用干细胞（的旁分泌作用或其分化潜能，来修复受损的泪腺、睑板腺或角膜上皮，是极具潜力的前沿方向。 功能性生物制剂： 除了补充NGF和Lacritin，利用富血小板血浆（PRP）或纤维蛋白原耗尽的人血小板裂解物制备的生物滴眼液，因其富含多种生长因子和抗炎因子，显示出促进眼表修复的强大潜力。 组织工程： 远期来看，利用组织工程技术在体外构建功能性的泪腺或睑板腺组织，并进行自体移植，可能为终末期干眼症患者提供终极解决方案。 6.2 创新药物递送系统（DDS） 如何将药物高效、长效、舒适地递送到眼表，是决定治疗成败的关键一环。未来DDS的发展将集中于： 6.3 人工智能（AI）的全方位赋能 AI技术将渗透到干眼症诊疗的每一个环节，带来革命性的变化。 AI辅助诊断： AI驱动的药物研发 AI赋能的临床试验与RWE分析 巨大的进步之下，挑战依然严峻。 需要共同努力。 免责声明：本文内容整理、编译自互联网公开内容渠道和报告。本公众号文中所有内容仅供学习参考，不能替代专业的医疗建议、诊断或治疗。如有关于健康状况的任何疑问，请务必咨询专业的医生和医疗机构。 图片源自网络，版权归原作者所有，如有侵权请联系。