Vision Disorders

Topical melanocortin therapy shows promise for treating glaucoma PL9588 lowers intraocular pressure (IOP) by increasing aqueous outflow Demonstrates neuroprotection independent of IOP reduction Supports continued development of PL9588 as a novel, dual-action glaucoma therapy CRANBURY, N.J., May 5, 2025 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company advancing innovative treatments targeting the melanocortin receptor system, today announced new preclinical data for PL9588, a novel melanocortin receptor agonist, presented at the 2025 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting. The findings support the potential of PL9588 as a topical treatment for glaucoma, combining both IOP-lowering and neuroprotective effects. The poster, titled "Activation of the Melanocortin System Increases Aqueous Outflow, Reduces Intraocular Pressure (IOP), and Protects Neurons in Glaucoma Models," was presented on May 4 by Dr. Alison Obr of Palatin. The full poster is available at . "Palatin is leading innovation in melanocortin science," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "Unlike current treatments that only lower intraocular pressure, PL9588 both reduces IOP and provides direct neuroprotection. This dual-action profile positions it as a potentially transformative therapy for glaucoma, and we are excited to move it forward into clinical development." Key Preclinical Findings for PL9588: Reduces intraocular pressure via aqueous outflow mechanism Increased fluid movement through the trabecular meshwork (TM) (p<0.05) Provides retinal neuroprotection independent of IOP lowering Reduced retinal cell stress/death by ~25% in damaged retinas (p<0.05) Decreased retinal ganglion cell (RGC) death in an ischemia/reperfusion (I/R) model (p<0.0001) Supports dual-action in Glaucoma Combines pressure reduction and neuronal protection Clear mechanism of action supports further development "Most current glaucoma therapies focus solely on lowering intraocular pressure," said Michael Raizman, M.D., Chief Medical Officer at Palatin. "Yet many patients still experience vision loss despite treatment. There remains a significant unmet need for therapies that go beyond pressure reduction — particularly those that can protect retinal neurons. PL9588 has the potential to address this critical gap." These findings position PL9588 as a potential next-generation candidate in the evolving landscape of glaucoma therapeutics. About Glaucoma Glaucoma is a progressive, often pressure-related disease that damages the optic nerve, leading to irreversible blindness. It affects approximately 79.6 million people worldwide (2020) and is a leading cause of preventable vision loss. Most therapies today reduce IOP but lack neuroprotective effects. According to Polaris Market Research, the global glaucoma market was valued at $5.71 billion in 2021 and is projected to reach $9.77 billion by 2030. This growth is driven by increasing prevalence and demand for innovative therapies. About PL9588 PL9588 is a synthetic peptide that activates melanocortin receptors 1 and 5 (MC1R and MC5R). It is being developed as a topical treatment for glaucoma, targeting both IOP reduction and retinal cell protection. About Melanocortin Receptor System The melanocortin receptor (MCR) system plays a critical role in regulating inflammation, immune response, and tissue repair. MCR agonists have shown promise in restoring tissue homeostasis in ocular, gastrointestinal, and renal diseases. By activating natural resolution pathways, PL9588 and other melanocortin agonists represent a new class of anti-inflammatory, neuroprotective therapeutics. 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 to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin's website at and follow Palatin on Twitter at @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. References: 1. Schuster AK, et al. Dtsch Arztebl Int. 2020;117(13):225-234. 2. Khatib TZ, Martin KR. Eye. 2017;31(2):218-224. 3. Spana C, et al. Front Pharmacol. 2019;9:1535. 4. Ahmed TJ, et al. Int J Inflam. 2013;2013:985815. 5. Wang W, et al. Front Endocrinol (Lausanne). 2019;10:683. 6. Cai S, et al. Cell Physiol Biochem. 2018;45(2):505-522. 7. Ng TF, et al. Biomolecules. 2024;14(5). 8. Kayne P, et al. Invest Ophthalmol Vis Sci. 2023;64(8):1399-1399. SOURCE Palatin Technologies, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

iSTAR Medical’s MINIject® demonstrates significant sustained 5-year efficacy in treating glaucoma in STAR-GLOBAL trial Five-year safety profile including corneal health confirmed and 38% IOP reduction sustained Over 5000 patients benefiting from limited commercial rollout of MINIject® worldwide to-date iSTAR Medical to advance MINIject® independently following ending of AbbVie partnership 24 April 2025: iSTAR Medical, a medtech company delivering breakthrough eye care solutions to patients, today announces positive five-year data from the STAR-GLOBAL trial for the supraciliary MIGS device, MINIject®. The data was presented by Andrew Tatham, Consultant Ophthalmologist at Princess Alexandra Eye Pavilion and University of Edinburgh, UK, and President of the UK and Ireland Glaucoma Society. STAR-GLOBAL is an extension trial of the initial EU clinical trials investigating the long-term safety and efficacy of MINIject® in patients with up to five-years of follow-up. Patients implanted with the MINIject® are invited to enroll into STAR-GLOBAL upon completion at two years of an iSTAR Medical clinical trial, to continue follow-up from two to five years. MINIject® is currently the only commercially available supraciliary MIGS implant. Since its launch more than 5,000 patients have been implanted across a number of commercial settings and continue to demonstrate meaningful and sustained clinical performance in lowering intraocular pressure (IOP) combined with a favorable safety profile. Data was obtained from 47 patients in STAR-GLOBAL who completed five-year follow-up from the STAR I, II and III trials (83.9% of the 56 patients enrolled). The efficacy results indicated a sustained and significant 38% reduction of IOP through to five years. Overall, 83% of patients achieved a >20% reduction in IOP from baseline and 80% had IOP of 18 or less at five-year follow-up, with 32% of patients remaining medication free. A favorable safety profile including corneal health was confirmed at five-year follow-up, with no serious adverse events related to the device or procedure in the STAR-GLOBAL follow-up period. Dr Karsten Klabe, Chief Surgeon at Breyer, Kaymak & Klabe Augenchirurgie, Düsseldorf, Germany, and a key investigator in the STAR trials, commented: “These very positive five-year follow-up results provide further validation of MINIject® as a safe, standalone procedure and an effective longer-term treatment option for glaucoma patients. This gives us further assurance that MINIject® can continue to benefit to patients even half a decade post-surgery.” Andrew Tatham, Consultant Ophthalmologist at Princess Alexandra Eye Pavilion and University of Edinburgh, UK, and President of the UK and Ireland Glaucoma Society said: “This five-year follow-up data is highly encouraging, demonstrating the ability of iSTAR Medical’s MINIject® to achieve sustained and significant lowering of IOP over the long term. This is consistent with the excellent safety and efficacy profile MINIject® has already demonstrated in previous STAR trials.” Michel Vanbrabant, CEO of iSTAR Medical, commented: “The strength and consistency of these five-year results reinforces our belief that MINIject® has the potential to become the surgical treatment of choice for glaucoma patients, offering a best-in-class solution for long-term glaucoma management. iSTAR Medical remains committed to further validating this hypothesis in its future studies, positioning MINIject® as the preferred surgical impact device among key opinion leaders, doctors, patients, and investors. With over 5000 patients now implanted, we continue to progress the development of MINIject® to address a significant unmet need in key global markets.” Conclusion of Alliance with AbbVie iSTAR Medical announces that its alliance with AbbVie, announced in 2022, has now ended. iSTAR Medical continues to operate its business as usual as an independent company and remains well positioned to continue the development of MINIject® in its ongoing US STAR-V trial with the aim of FDA submission in 2028 and the continued commercial roll-out in Europe and other global territories. Amber Fennell, Chris Welsh, Kris Lam iSTAR Medical is committed to delivering breakthrough eye care solutions. Our most advanced product, MINIject®, is approved in Europe for the treatment of open-angle glaucoma – the leading cause of irreversible blindness – and we are aiming to seek market approval in the US. We believe MINIject®’s distinctive tissue-integrating capabilities unlock a safer, and more effective option for patients. We are building an exceptional team and pipeline of potentially leading products such as MINIject® to establish new treatment paradigms in eye care conditions with the highest patient needs. MINIject® is iSTAR Medical’s innovative MIGS device for patients with primary open-angle glaucoma. MINIject® combines the distinctive porous structure of its proprietary STAR material with the IOP lowering power offered by the supraciliary space. As a result, it is designed to enhance natural fluid outflow, reducing intraocular pressure (IOP) and the need for medication, while bio-integrating with surrounding tissue, limiting inflammation, fibrosis and subsequent complications. Glaucoma is a progressive disease affecting over 100 million people globally, of which primary open-angle glaucoma is the most common form.1,2 IOP reduction, through medication or surgery, helps delay disease progression.3 Medication is generally the first line treatment, but the progressive addition of multiple drops can burden patients with side effects, compliance challenges and costs.2,3 Invasive surgery can present risks with irreversible complications and often requires long-term patient management.2,3 MIGS is the most promising and fastest-growing glaucoma therapy due to its enhanced safety profile.2 MINIject® is potentially best-in-class for its promising long-term efficacy and safety. 1 Jonas JB, Aung T, Bourne RR et al. "Glaucoma". Lancet 2017; 390: 2083–93 2 Market Scope, “2021 Glaucoma Surgical Device Market Report”, July 2021. 3 “European Glaucoma Society Terminology and Guidelines for Glaucoma”, 4th Edition: British Journal of Ophthalmology. 2017;101:1-195 https://bjo-bmj-com.libproxy1.nus.edu.sg/content/101/5/73 The content above comes from the network. if any infringement, please contact us to modify.

Johnson & Johnson’s gene therapy for a genetic disease that leads to vision loss called X-linked retinitis pigmentosa (XLRP) failed a pivotal trial, according to an update to a J&J healthcare provider website. At one year, the gene therapy, called bota-vec, didn’t meet its primary endpoint in the Phase 3 LUMEOS study, though results were “directionally supportive,” according to the website , which appears to have been updated Friday. The primary endpoint measured the change in patients’ ability to navigate through a vision-guided mobility assessment maze. “We’re working to understand the totality of the data, inclusive of the clinical relevance of improvement shown on the majority of secondary endpoints, as we evaluate strategic options and next steps,” a J&J spokesperson told Endpoints News via email. The Phase 3 study fail comes as large biopharma companies are pulling back from AAV gene therapy work. Vertex became the latest company to stop research on AAV gene therapy, Endpoints reported Friday. And Pfizer, Takeda, Roche and Biogen have previously cut back on AAV gene therapy research or clinical programs. J&J acquired the gene therapy, known as bota-vec, from MeiraGTx for $65 million upfront in 2023 after previously making licensing deals for three eye disease gene therapies, including bota-vec, from the smaller biotech. The gene therapy delivers functional copies of the RPGR gene via viral packages called adeno-associated viruses, or AAVs. That gene is mutated in people with X-linked retinitis pigmentosa, a disease that primarily impacts boys and men. The Phase 3 study had enrolled 95 participants and split them into three groups: low-dose gene therapy, high-dose gene therapy, or deferred treatment — a group of patients who served as the comparator arm and were meant to receive the gene therapy after the primary endpoint measurement. A Biogen gene therapy for XLRP failed a mid-stage study in 2021. Beacon Therapeutics is studying a gene therapy for the rare eye disease, and last year raised $170 million. Editor’s note: This story was updated to include a statement from a J&J spokesperson.