PolyActiva’s Post

Why do we so urgently need new treatments for #glaucoma?   Professor Philippe Denis, Head of Ophthalmology at the Croix-Rousse University Hospital in Lyon and a leading expert in the field, outlined his thoughts on this unmet medical need. In a recent webcast, Prof. Denis explained why Nicox’s NCX 470 has the potential to improve options for patients and address a significant market.   “For a very long time, we had therapeutic families that were relatively effective, but sometimes insufficient, and the prostaglandins have revolutionized the market. And it has to be said that, up to now, for the last years, we have had the impression that the market is stagnating because there are no new therapeutic families, there are no new drugs coming onto the market and changing the game. And so NCX470, which is derived from prostaglandins, is extremely interesting,” Prof. Denis said.   “The fact of having, as with NCX470, a potentially interesting neuroprotective effect directly on the optic nerve can be very interesting. This means that today, if we were to project into the future using this molecule, we could use the product in patients for whom latanoprost is not sufficient, or in patients who are intolerant to latanoprost. And this represents a huge market, since it [latanoprost] is the world's leading molecule in terms of prescriptions, and of course this is a quite an encouraging sign for its [NCX 470’s] commercial future and for the patients.”   Watch the full webcast here https://lnkd.in/g4y3Xszn   #biotech #drugdevelopment #healthcare #eyecare #eyedrops #pharmaceuticals

PolyActiva has released new findings from its phase 2 clinical trial (LATA-CS102) evaluating the use of PA5108, its novel glaucoma treatment technology, in providing long-term drug delivery for glaucoma patients. Learn more on Glance: https://lnkd.in/e2PPSqhu #GlanceNews #eyecare Vanessa Waddell

Nicox has entered into an exclusive research and global license option agreement with Glaukos Corporation for NCX 1728, our novel nitric oxide (NO)-donating phosphodiesterase-5 (PDE5) inhibitor.  “Glaukos possesses expertise in the treatment of ophthalmic disorders and has unique drug delivery capabilities which could optimize NCX 1728 for uses including reduction of intraocular pressure, neuroprotection and as a potential treatment for retinal diseases.” said Doug Hubatsch, Chief Scientific Officer of Nicox.   Glaukos will evaluate NCX 1728, at its cost, in a pre-clinical research program agreed between Nicox and Glaukos. The program will explore indications for the treatment of glaucoma, including neuroprotection, and in the treatment of retinal diseases. Glaukos has an option to license NCX 1728 on an exclusive global basis for development in these ophthalmic conditions, which can be exercised within certain specified periods, the first of which is in 12 months. Full details are in our Press Release: https://lnkd.in/dYFUkQ5u #glaucoma #biotech #businessdevelopment #partnering 

Sun Pharma, Moebius Medical Present Positive Data From Phase 2b Trial Of MM-II In Painful Knee Osteoarthritis Patients At EULAR 2024 SUN PHARMA and Israel-based Moebius Medical Ltd. have presented data demonstrating the durability of pain relief achieved in symptomatic knee OA patients through 26 weeks post injection of MM-II. The results, presented at EULAR 2024, are based on an analysis from the randomized, controlled, Phase 2b clinical study (NCT04506463). MM-II is a novel non-opioid product that uses a proprietary suspension of large, empty, multilamellar liposomes which are intended to reduce friction and wear on the joint and thus relieve joint pain. Sun Pharma and Moebius Medical, who have been jointly developing this product, have announced plans to initiate a Phase 3 clinical program and to seek a CE Mark for the product in the European Union. Philip Conaghan Abhay Gandhi Moshe Weinstein For more information click on the link below: https://lnkd.in/gnYnwykA #sunpharma #sunpharmanews #moebiusmedical #oteoarthritis #EULAR2024

Retina clinical trial news from Market Scope: Japan’s Sumitomo Pharma America, Inc. announced Nov. 29 that the US FDA had cleared its investigational new drug (IND) application for a Phase I/II trial of its allogeneic retinal sheet derived from induced pluripotent stem cells, a treatment candidate targeting retinitis pigmentosa. Sumitomo said it had been in talks with Massachusetts Eye and Ear, with the aim to begin transplantation in RP patients in fiscal 2025. #celltransplantation #celltherapy #clinicaltrial #inheritedretinaldisease #retinitispigmentosa #stemcells

Using PROSE Scleral Lenses as a Drug Delivery Device BostonSight’s research team published a ground-breaking study – “Utilizing PROSE as a Drug Delivery Device for Preservative-Free Cyclosporine 0.05% for the Treatment of Dry Eye Disease: A Pilot Study” in the journal Clinical Ophthalmology. In the study, researchers utilized PROSE devices (a specialty scleral lens) as a drug delivery device for preservative-free cyclosporine 0.05% for the treatment of dry eye disease. To our knowledge, this report is the first to ever describe a prospective clinical trial utilizing a pharmaceutical in this manner. This study sets forth the template, concepts, and questions that are open to further investigation in this exciting area of drug delivery. Ultimately, in the future, we hope this concept and research will lead to an additional ocular management strategy that will utilize the PROSE and SCLERAL platforms as drug delivery devices to open new avenues to improve ocular health and to improve the lives of our patients. The study authors include staff from BostonSight, Tufts University School of Medicine, and the Department of Mathematical Sciences at Worcester Polytechnic Institute (WPI): Monica Nabil Nakhla, Ria Patel, Estelle Crowley, Yichen Li, Thelge Buddika Peiris, and Daniel Brocks. #PROSE #PatientSuccess #PatientExperience #BostonSight #PatientCare #ScleralLens #ScleralLenses #Optometry #Optometrist #DryEyeDisease #DryEye #DryEyeRelief #Keratoconus #EyeCare #Scleral #ContactLens #SpecialtyLenses

Good morning. There has been some interesting news from the clinic and regulators over the past week across biotech, drug discovery, and medical devices. Here are some highlights that I found. 🛎 J&J wins expanded FDA clearance for knee surgery robot. Johnson & Johnson has identified Velys as a product that can help it regain market share from rivals such as Stryker. 🛎Abbott wins CE mark for dual-chamber leadless pacemaker. Abbott sees the device as a product that can help its rhythm management business grow 6% to 7%. 🛎Eli Lilly’s Alzheimer’s disease treatment sailed through an FDA advisory committee meeting Monday, with panellists praising the therapy as innovative—while also cautioning about a lack of data on specific subgroups. 🛎Gilead, with approval in sight, shows $4.3B liver disease drug improves outcomes out to 2 years. 🛎Lykos Therapeutics’ attempt to get the first ever MDMA treatment approved in post-traumatic stress disorder suffered a blow when an FDA advisory committee voted against recommending approval. 🛎Moderna's methylmalonic acidemia candidate nabs spot in FDA pilot for rare disease drugs. 🛎Oculis is forging ahead with its precision medicine approach to treating dry eye disease, outlining plans to finalize a phase 3 study after seeing some signs of efficacy in a subpopulation in its mid stage trial. 🛎Analysts brand Huntington's trial 'underwhelming' as Sage Therapeutics no closer to proving dalzanemdor's efficacy. 🛎Medtronic recalls neurosurgery navigation system for software error. A problem with the Stealthstation S8 could cause incorrect device placement during surgery. It is the fourth recall of Stealthstation software in the past 12 months. 🛎Skye Bioscience unfortunately ends eye disease R&D efforts after glaucoma drug's phase 2 fail. #medicaldevices #therapeutics #drugdiscovery

Roche is set to reintroduce its Susvimo eye implant, two years after a recall due to manufacturing issues. With FDA approval, the innovative treatment for wet age-related macular degeneration (AMD) is ready for #rollout. 🔍 Key Insights - - Enhanced Convenience - Susvimo requires only two refills per year, offering an alternative to frequent eye injections. - Regulatory Green Light - After addressing manufacturing concerns, FDA-approved updates ensure improved performance. - Market Dynamics Susvimo aims to compete with Regeneron and Bayer’s Eylea, which is known for its safety and accessibility. ❓ Questions to Consider - How will Susvimo's return impact patient preference for AMD treatments? - What strategies will Roche use to regain and expand market share? - How will competitors like Eylea and Vabysmo respond to Susvimo's reentry? #Ophthalmology #Susvimo #Roche #HealthcareInnovation

It seems to me that this trial only demonstrated safety but not efficacy or potency as a Phase 1 Clinical Trial. As to the effectiveness of these plated Exosomes it appears that there was no benefit to these exosomes over a placebo in wound healing for healthy subjects. I read this fairly quickly so maybe I missed the value of plated Exosomes. There are companies selling topical plated Exosomes for anti-aging and other purposes. These plated Exosomes companies are selling cosmetic serum MedSpa products with a claimed one trillion Exosomes per vial. Is there any efficacy or potency to this type of Exosomes derived from Platelets. I can’t find any clinical evidence supporting these products as represented in their ads. Dr. Carla Mazzeo Michael Heke Erin Crowley

Unlock Mondays with an exciting publication! Ever wondered about the pharmacokinetic strategies and their influence on efficacy and durability of intraocular drugs? Explore the insights from the review 'Intraocular drugs: pharmacokinetic strategies and the influence on efficacy and durability.' This study delves into the modern treatment of chorioretinal vascular diseases, shedding light on the properties and behavior of anti-VEGF drugs delivered intravitreally. How might these findings shape the future of intraocular drug development? Stay informed with the latest research in ophthalmology. Discover it: https://lnkd.in/d7CSAdBc #Ophthalmology #Publication #IntraocularDrugs #Pharmacokinetics #Efficacy #Durability"