Market Overview

Companies Strive to Tackle Ocular Diseases as Rates of Incidences Grow


NEW YORK, Nov. 21, 2019 /PRNewswire/ -- There is an alarming increase in the frequency of eye-related diseases, particularly in developed countries, which in turn is expected to drive the growth of the global retinal drugs market. There are many types of retinal diseases: some of these diseases involve only the macula (central part of the retina) such as age-related macular degeneration; other diseases can impact the entire retina such as retinal detachment or diabetic retinopathy. Overall, data published by the American Academy of Ophthalmology in 2016 shows that about 93 million people had diabetic retinopathy worldwide, of which, 4.2 million patients were from the U.S. And according to Grand View Research, the global retinal disorder treatment market size was valued at USD 8.8 Billion in 2018. Additionally, it is expected to register a CAGR of 7.6% over the forecast period. Generally, the market growth can be primarily attributed to the increased funding by regulatory bodies for conducting research on ocular disorders. Amarantus Bioscience Holdings, Inc. (OTC:AMBS), Applied Genetic Technologies Corporation (NASDAQ:AGTC), IVERIC bio, Inc. (NASDAQ:ISEE), Eyenovia, Inc. (NASDAQ:EYEN), IRIDEX Corporation (NASDAQ:IRIX)

Several initiatives have been commenced around the globe to spread awareness about diagnosis and treatment methods of ophthalmic diseases. The International Centre for Eye Health focuses on growing mindfulness about eye health problems and treatments. In the meantime, the World Glaucoma Association has been positioning the World Glaucoma Congress for the past six years to increase awareness and conversation about glaucoma treatment advancements. And the Macular Degeneration Association, Inc. arranges seminars every month across various regions to increase treatment penetration for age-related macular degeneration. In addition, technological advancements and increasing strategic collaborations are some of the other factors expected to drive the market for retinal disorder treatments. For example, in October 2018, Ophthotech Corporation (IVERIC bio) entered into an agreement with the University of Florida Research Foundation and the University of Pennsylvania to develop and commercialize an adeno-associated virus (AAV) gene therapy product for the treatment of Best Vitelliform Macular Dystrophy (BVMD).

Amarantus Bioscience Holdings, Inc. (OTC:AMBS) today announced breaking news that, "that subsidiary MANF Therapeutics has been issued a Chinese patent covering the use of mesencephalic astrocyte-derived neurotrophic factor (MANF) and/or cerebral dopamine neurotrophic factor (CDNF) for the treatment of retinal disorders. MANF Therapeutics is focused on the development of MANF as an intravitreal injection for the treatment of glaucoma, macular degeneration, retinitis pigmentosa and Wolfram Syndrome.

The ophthalmic therapeutic market is expected to reach $35B by 2025 according to Grand View Research, Inc. Glaucoma affects approximately 4 million people in the United States, with a total drug market size of approximately $3B. With its novel mechanism of action, MANF addresses key pathways in a variety of 'back of the eye' retinal conditions, which is an area with significant unmet medical need.

MANF has significant therapeutic potential across multiple orphan ophthalmological conditions such as RAO and  retinitis pigmentosa, where MANF has already received orphan drug designations from the FDA, Wolframkk Syndrome, as well as in larger indications such as glaucoma, Parkinson's disease, diabetes and cardiovascular disease, including stroke and myocardial infarction. MANF Therapeutics is the front-runner and primary worldwide intellectual property (IP) holder for MANF-based therapies including protein therapy, gene therapy and cell therapy. The Company owns rights to composition of matter patents and patent applications for MANF and owns, or has licenses to, method of use patents and patent applications covering the use of MANF in ophthalmology, neurology and diabetes. Amarantus is currently evaluating strategic options to advance MANF into clinical development.

Amarantus has entered into a binding term sheet to license MANF to Emerald Organic Products. The transaction is expected to close in the fourth quarter of 2019.

About MANF Therapeutics, Inc.

MANF (mesencephalic-astrocyte-derived neurotrophic factor) is believed to have broad potential because it is a naturally-occurring protein produced by the body to reduce/prevent apoptosis (cell death) in response to injury or disease, via the unfolded protein response. By administering exogenously produced MANF to the body, Amarantus is seeking to use a regenerative medicine approach to assist the body with higher quantities of MANF when needed. Amarantus is the front-runner and primary holder of intellectual property around MANF and is initially focusing on the development of MANF-based protein therapeutics.

MANF's lead indication is Wolfram Syndrome, and additional indications including glaucoma, Parkinson's disease, diabetes and retinitis pigmentosa are envisioned. Further applications for MANF may include Alzheimer's disease, traumatic brain injury, myocardial infarction, antibiotic-induced ototoxicity and certain other orphan diseases.

In April 2017, Amarantus incorporated the wholly-owned subsidiary MANF Therapeutics, Inc. to focus on progressing pre-clinical and clinical development of MANF.

About Amarantus Bioscience Holdings, Inc.

Amarantus Bioscience Holdings (AMBS) is a JLABS alumnus biotechnology company developing treatments and diagnostics for diseases in the areas of neurology, regenerative medicine and orphan diseases through its subsidiaries. The Company's 80.01%-owned subsidiary Breakthrough Diagnostics, Inc., currently a joint venture with Todos Medical, Ltd. has licensed intellectual property rights to the Alzheimer's blood diagnostic LymPro Test ® from Leipzig University that was originally developed by Dr. Thomas Arendt, as well as certain rights to multiple sclerosis diagnostic MSPrecise™ and Parkinson's diagnostic NuroPro. Amarantus entered into a joint venture agreement with Todos Medical, Ltd. to advance diagnostic screening assets, and Todos has exercised its exclusive option to acquire Amarantus' remaining ownership in Breakthrough in exchange for approximately 50% ownership of Todos. The transaction is expected close before the end of the first quarter of 2020. Amarantus also owns approximately 30% of the common shares of Avant Diagnostics, Inc., a healthcare data-generating technology company that specializes in biomarker assay services that target multiple areas of oncology.  Avant provides precision oncology data through its TheraLink® assays to assist the biopharmaceutical industry and clinical oncologists in identifying likely responders, initially for breast cancer, to over 70 FDA-approved drug treatments.

AMBS 50%-owned subsidiary Elto Pharma, Inc. has development rights to eltoprazine, a Phase 2b-ready small molecule indicated for Parkinson's disease levodopa-induced dyskinesia, Alzheimer's aggression and adult attention deficit hyperactivity disorder, commonly known as ADHD. The   AMBS acquired Cutanogen Corporation from Lonza Group in 2015. Cutanogen is preparing for pivotal studies with Engineered Skin Substitute (ESS) for the treatment of pediatric life-threatening severe burns. ESS is a regenerative medicine-based, autologous full-thickness skin graft technology originally developed by the Shriner's Hospital that can be used to treat severe burns, as well as several other catastrophic and cosmetic dermatological indications. AMBS' wholly-owned subsidiary, MANF Therapeutics Inc. owns key intellectual property rights and licenses from a number of prominent universities related to the development of the therapeutic protein known as mesencephalic astrocyte-derived neurotrophic factor ("MANF"). MANF Therapeutics is developing MANF-based products as treatments for ophthalmological disorders such as Wolfram Syndrome, retinitis pigmentosa and glaucoma, as well as neurodegenerative diseases such as Parkinson's disease. MANF was discovered by the Company's Chief Scientific Officer John Commissiong, PhD. Dr. Commissiong discovered MANF from AMBS' proprietary discovery engine PhenoGuard, and believes several other neurotrophic factors remain to be discovered. Amarantus has entered into a binding letter of intent to license the therapeutic assets from Elto Pharma, Cutanogen and MANF Therapeutics to Emerald Organic Products."

Applied Genetic Technologies Corporation (NASDAQ:AGTC) is a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases.  "Presenting promising topline six-month and preliminary three-month data from the dose-escalation cohorts of our ongoing Phase 1/2 clinical programs in X-linked retinitis pigmentosa and both achromatopsia trials, respectively, was a key milestone for AGTC," said Sue Washer, President and CEO of AGTC. "We are on track to present additional data from all three programs and are advancing our discussions with the FDA such that we can finalize the design and initiate a pivotal trial in X-linked retinitis pigmentosa in 2020. We also announced the expansion of our preclinical pipeline, including naming a potential treatment for Stargardt disease as our next orphan ophthalmology product candidate, and the establishment of a strategic collaboration with Otonomy.  On November 5, 2019, AGTC identified Stargardt disease as its second preclinical ophthalmology program and reported that its dual AAV vector system effectively expressed full-length ABCA4 protein in the retinal tissue of non-human primates following subretinal injection.

IVERIC bio, Inc. (NASDAQ:ISEE) announced initial topline data confirming that Zimura® (avacincaptad pegol), the Company's complement factor C5 inhibitor, met its prespecified primary endpoint in reducing the rate of geographic atrophy (GA) growth in patients with dry age-related macular degeneration (AMD) in a randomized, controlled Phase 2b clinical trial.  Dry AMD is a significant cause of moderate and severe loss of central vision in older adults, affecting both eyes in the majority of patients.  "IVERIC bio's unwavering commitment to science has resulted in compelling Phase 2b data in GA secondary to dry AMD, a major public health problem that has devastating effects on our patients," stated Marco A. Zarbin, M.D., Ph.D., FACS, Professor and Chair, Institute of Ophthalmology and Visual Science, Rutgers-New Jersey Medical School, Newark, New Jersey. "As a retina specialist, Zimura's impressive efficacy results and favorable safety profile observed to date in this trial indicate its potential as a future treatment for this growing patient population, which represents an urgent unmet medical need."

Eyenovia, Inc. (NASDAQ:EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose therapeutics utilizing its patented piezo-print delivery technology, announced last month that the Company is advancing the development of its MicroLine program for the improvement in near vision in patients with presbyopia towards Phase III development.  MicroPine is Eyenovia's first-in-class topical treatment for progressive myopia, a back-of-the-eye condition commonly known as nearsightedness. Progressive myopia is estimated to affect close to 5 million people in the United States who suffer from uncontrolled axial elongation of the sclera leading to increasing levels of myopia and in some cases major pathologic changes such as retinal atrophy, macular staphylomas, retinal detachment and visual impairment.  As a result of prioritizing MicroLine in tandem with its MicroPine (progressive myopia) and MicroStat (mydriasis) programs, the Company is deferring development activities for its MicroProst (glaucoma and ocular hypertension) and MicroTears (red eye and itch relief/lubrication) programs.

IRIDEX Corporation (NASDAQ:IRIX), a provider of innovative ophthalmic laser-based medical products for the treatment of glaucoma and retinal diseases, announced earlier in April, that its patented MicroPulse® technology played a pivotal role in research presented at the 2019 Association for Research in Vision & Ophthalmology (ARVO) and American Society of Cataract & Refractive Surgeons (ASCRS) meetings, to be held in Vancouver, British Columbia, and San Diego, CA, respectively.  "There is considerable clinical value in non-invasive procedures that lower intraocular pressure without placing activity restriction on the patient postoperatively," commented Jella An, MD, Director of Glaucoma Service, University of Missouri. "With its strong safety and efficacy profile, MicroPulse transscleral cyclophotocoagulation (MP-TSCPC) offers glaucoma specialists compelling options for treating patients who don't respond to medication alone," commented Dr. An. "I am looking forward to sharing how the research I have conducted alongside fellow glaucoma specialists continues to validate MP-TSCPC in clinical practice."

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