Controlling Myopia with Myopine™Myopia is caused by the abnormal elongation of the eye along its axial length. Myopia rates are rising globally, and in Singapore, 80% of people are afflicted by the age of 18. In addition, severe myopia is associated with increased risk of other eye conditions, such as macular degeneration, retinal detachment, cataracts and glaucoma. 1% atropine eye drops, the currently available dose, can be used to slow the progression of myopia, but is unpopular due to its side effects.
The TechnologyResearch performed at SERI over the past two decades has shown that 0.01% atropine eye drops can be used to slow the progression of myopia by up to 60%, without any significant side effects. Given that myopia commonly develops in childhood and stabilises after a period of progression, low-dose atropine can be used during the period of progression to reduce the severity of myopia and the risk of other ocular complications later in life.
Target MarketChanging lifestyles have led to increasing rates of myopia around the world. In the United States and the European Union, 40-50% of adults are affected. In East Asia, countries like South Korea, Taiwan, Singapore, China and Japan have myopia rates of 80-90%. This represents a large and increasing market that can benefit from the use of low-dose atropine eye drops.
Current Stage of DevelopmentOur low-dose atropine formulation, marketed as Myopine™, is already in use at SingHealth hospitals, the SNEC Myopia Clinic and private clinics throughout Singapore. Myopine™ is currently approved for clinical use in Singapore by the Health Sciences Authority on a named patient basis, and is also available on a similar basis in Japan and Malaysia.
A third large clinical trial, ATOM 3, is currently underway. We are continuously seeking partners to make this available in other markets and to further develop the drug to enhance the mode of delivery and efficacy.
Territories available for licensing: America (north and south), parts of Europe including Russia, Africa, India, Australia and New Zealand
Categories: Pharmaceuticals, Myopia
Intellectual Property:
Drug DeliveryThe effectiveness of drugs is determined not only by the active drug ingredient, but also by the delivery method. Different modes of delivery can carry the active compound more efficiently to the target site, as well as provide sustained release over periods ranging from days to months, depending on the appropriate treatment duration.
Treatments for ophthalmic diseases such as glaucoma, ocular allergies and inflammation are usually met with poor patient adherence when drugs have to be frequently applied. To improve patient compliance adherence, quality of life and overall efficacy, sustained drug release methods should ideally be tailored to each situation.
The TechnologyWe have developed a suite of ocular drug delivery platforms that are designed to meet the needs of different ophthalmic conditions. These include a liposomal platform, capable of penetrating the sclera and delivering drugs into the vitreous cavity, hyaluronic acid-based systems for drug delivery in wound healing, biodegradable microfilm ocular implants with varying drug release profiles, and layer-by-layer nanoparticles for nucleic acid delivery.
Target Market The commercial market size for nanotechnology-enabled drug delivery is forecast to reach US$136 billion by 2021. Of the various nanoparticle carriers available, liposomes are predicted to offer the largest addressable market of US$15 billion in 2021.
Current Stage of DevelopmentOur patented liposomal latanoprost technology has been licensed to Peregrine Ophthalmic Pte Ltd and is currently in clinical development for glaucoma therapy. The hyaluronic acid-based system is patented and we are currently carrying out pre-clinical studies on wound healing. The microfilm ocular implants for the sustained delivery of prednisolone, timolol and tacrolimus have shown good results in preclinical testing and are being optimised first in man trials. Our new siRNA delivery platform to treat ocular fibrosis has also shown very promising results in preclinical testing.
Categories: Pharmaceuticals, Drug delivery
Treating Ocular Angiogenesis - A novel PeptideAMD is the leading cause of blindness in adults. 30-50% of patients are either poor- or non-responders to current anti-VEGF treatment, in which they require monthly intravitreal (IVT) injections. 51% of the treated patients still have the active disease after two years. Current anti-VEGF therapy for retinal angiogenesis disorder suffers from poor prognosis and requires repeated IVT administration. Therefore, there is a perceived need for long-acting drugs which reduce the multiple visits and preferably administered through non-invasive routes.
The TechnologyWe have developed a small synthetic novel peptide that shows good anti-inflammatory/anti-angiogenic and endothelial cell inhibition activity. In our experiments, this novel peptide has shown to suppress angiogenesis induced by both VEGF and bFGF by interfering with multiple aspects of angiogenesis including proliferation, migration and tubule formation. It is highly water soluble and very stable at room temperature. In mice CNV model, the peptide shows efficacy via IV; IVT and oral route and shows no toxicity at 5mg/eye or elevation of IOP change. This peptide shows efficacy as close to Eylea in non-human primates (NHP) wet AMD model.
Target MarketThe market for retinal diseases including AMD and DME is expected to increase due to the growing prevalence of these diseases. In 2010, the overall market for retinal disease was estimated to be $3.5billion, of which AMD represented the largest share with a single drug and Lucentis generating a revenue of $2.9billion. Ocular anti-neovascularisation products help in the prevention of extrusive pathological growth of blood vessels between the choroid and the macula in wet AMD.
Currently, there are only three drugs approved for the treatment of wet AMD: an anti-VEGF monoclonal antibody (Roche/Novartis' Lucentis), a light activated drug (Novartis' Visudyne), and an aptamer (Pfizer/OSI's Macugen). The US launch of Novartis' Macugen in 2005 (followed by an EU launch in 2006) played an important role in significantly shifting physicians' attention from the photo-activated destruction of neovasculature to anti-angiogenesis. However, Macugen failed to derive considerable benefits from its early-to-launch advantage, due to the FDA's approval of Lucentis in the following year (with an EU launch in 2007). In addition, the unavailability of alternate therapy options in the market and physician preference has triggered increased off-label use of Roche/Genentech's Avastin for the indication.
Current Stage of DevelopmentOur invention has undergone proof-of-concept studies in non-human primate animal models. We are now planning GLP toxicology, PK studies. A patent on the technology is available for licensing from SERI.
Categories: Therapeutics, AMD, corneal neovascularisation, wound healing
Correcting Presbyopia: Long-term Ocular Tissue StoragePresbyopia, or far-sightedness, is an age-related loss of lens accommodation that results in an inability to focus at near distances. It affects over 90% of individuals over 40 years old, and is the most common physiological change occurring in the adult eye. Currently, potential treatments involve the insertion of artificial corneal inlays, but these devices are ultimately still foreign bodies in the cornea. Such implants can affect cornea permeability, resulting in poor surgical healing and results, among other side effects.
The TechnologyOur biological solution for presbyopia (corneal lenticule reimplantation following cryopreservation), involves reimplanting a lenticule that has been obtained from a refractive procedure on the eye. Because the implant was taken from the patient’s own eye, it will lead to significantly fewer side effects and yet provide the same refractive correction power as artificial inlays.
Target MarketThere are an estimated 1.7 billion people with presbyopia worldwide; this figure is expected to reach 2.1 billion by the year 2020. Our technology allows for the potential use of human corneal autografts or allografts for presbyopia management and corneal conditions such as ectatic corneas.
Current Stage of DevelopmentOur invention has undergone proof-of-concept studies in rabbit and non-human primate animal models. These studies show the complete integration of donor stroma with no scar formation and other important end-points. A patent on the technology is available for licensing from SERI.
Categories: Device, Tissue graft, Presbyopia
E-polylysineAntibiotic resistance is a growing threat that will increasingly reduce the efficacy of existing treatment options for infectious diseases. Unfavourable economic returns and regulatory challenges have led to decreased investment into the development of new antibiotics, and as such, there is a need for new classes of antimicrobials that can target a wide range of pathogens.
The TechnologyE-polylysine (ePL) is a naturally occurring peptide that has been approved by the US FDA as a generally safe material suitable for food consumption. However, ePL has also shown an antimicrobial effect against a wide spectrum of pathogens. Starting with ePL, we have used rational design to enhance the stability and bacteria-killing ability of modified peptides. In addition to their broad spectrum antimicrobial effects, EPL peptides have also been shown to have anticancer effects in preliminary studies of B and T cell lymphoma lines.
Target MarketA patent has been filed for the use of modified ePL as an antimicrobial in contact lens and lens care applications. The global market for contact lenses was US$9.2 billion in 2015 and is expected to grow to US$10.1 billion by 2020. With regard to the anticancer effects, the B-cell Non-Hodgkin’s Lymphoma (NHL) treatment market is set to rise in value from $4.38 billion in 2014 to reach $5.45 billion by 2024.
Current Stage of DevelopmentWe have carried out pre-clinical studies of ePL antimicrobial potency in rabbit models of infectious keratitis with successful outcomes. Together with in vitro studies, our results show the excellent antimicrobial properties of ePL for topical applications in eye disease. We have conducted the in vitro studies on B and T cell lines. The results showed remarkable anticancer effect. Further in vitro and in vivo studies with a view to establishing superiority, are soon to be underway.
Categories: Pharmaceuticals, Antimicrobials, Anticancer
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