Innovative Biotechs Look to Tackle Ocular Ailments

NEW YORK, Nov. 6, 2019 /PRNewswire/ -- Visual impairment is one of the most common health conditions that negatively impact millions of Americans' physical and mental health. Visual impairment is defined as 20/40 vision, or worse, in the better eye even with eyeglasses, according to the American Academy of Ophthalmology. Minor eye impairment conditions such as astigmatism aren't significantly serious and therefore do not necessarily mean a person has "bad eyes," according to the Kellogg Eye Center of the University of Michigan. On the other hand, serious eye conditions such as glaucoma can become detrimental if the damage continues to persist. Notably, glaucoma is one of the most common ophthalmic disorders encountered in primary and secondary care. Glaucoma is classified as a group of eye conditions that damage the optic nerve, which is vital for optimal eye vision, according to the Mayo Clinic. The damage is commonly caused by an abnormally high pressure buildup in the eye. Unfortunately, many forms of glaucoma do not have early warning signs and can ultimately lead to vision loss or complete blindness. Additionally, glaucoma generally affects older adults, but it can occur at any age. As such, approximately three million Americans are affected by glaucoma, but the number is also expected to soar to four million by 2030, according to the Glaucoma Research Foundation. And despite the number of treatments available, medical practitioners are continuously working to develop new therapies to effectively aid patients suffering from glaucoma. According to data compiled by Fortune Business Insights, the global glaucoma therapeutics market was valued at USD 6.27 Billion in 2018. By 2026, the market is expected to reach USD 10.09 Billion while registering a CAGR of 6.1%. Q BioMed Inc. (OTC: QBIO), Johnson & Johnson (NYSE: JNJ), Allergan plc (NYSE: AGN), Bausch Health Companies Inc. (NYSE: BHC), Aerie Pharmaceuticals, Inc. (NASDAQ: AERI)

Typically, medical professionals recommend getting regular dilated eye examinations as well as practicing proper eye safety in order to prevent glaucoma. However, in more developed stages, patients are required to seek medical attention to treat glaucoma. Often times, patients undergo eye surgery or turn to medicated eye drops to treat glaucoma. As such, the therapeutics market is flooded with branded medications and generic drugs that are commonly used to reduce elevated intraocular pressure (IOP) and to prevent damage to the optic nerve. However, in some cases, glaucoma can continue to progress even after the prescribed dose of medication is completed. Subsequently, patients are required to seek further medical attention. Generally, prostaglandin analogues are preferred as a front-line treatment because of their effectiveness in reducing the IOP and fewer side effects compared to other treatments. Prostaglandin analogues are eye drops that works towards increasing the outflow of intraocular fluid from the eye. Fortune Business Insights noted that prostaglandin analogues accounted for 40.2% of the glaucoma therapeutics market share in 2018 and are expected to remain dominant throughout the forecasted duration. Moreover, other drug classes in glaucoma therapy such as beta blockers, alpha-adrenergic agonists, carbonic anhydrase inhibitors, and combination drugs are also widely popular in the marketplace. Ian Conner, MD., Assistant Professor of Ophthalmology and Chief of Ophthalmology at UPMC Shadyside notes that this is "an exciting time in the treatment of glaucoma. There are a number of new medical and surgical options in the past few years, with more on the immediate horizon. In the next decade, we expect a complete revolution in the treatment of glaucoma, including sustained release medications to limit the burden on patients, and better and safer surgeries that can be used at any stage of the disease," according to The Eye & Ear Foundation of Pittsburgh. 

Q BioMed Inc. (OTCQB: QBIO) announced yesterday that, "its technology partner, Mannin, has received a $7.5M grant from the German state of Saxony. Mannin is a research-stage biotechnology company focused on the discovery, development, and commercialization of therapeutics for vascular diseases. It was founded in July 2012 and is led by President and CEO, Dr. George Nikopoulos. Q BioMed and Mannin have been partners since 2015.

The overall objective of the grant is to fund the development of novel pharmaceuticals and biologic treatments for glaucoma. There have been few innovations in glaucoma drug development in recent history and glaucoma remains a leading cause of blindness in Europe. More innovation and solutions are required to address the unmet needs of more than 12 million Europeans who suffer from this disease.

The approval of the grant means that Q BioMed and Mannin can significantly accelerate the development of these therapeutics. Denis Corin, CEO of Q BioMed, said of the grant, 'We are thrilled that we will be able to speed the development of these promising therapeutics and bring new innovation to glaucoma patients as soon as possible. Our partnership with Mannin and now, the government of Saxony is important to the advancement of this unique drug platform and we look forward to supporting the build-out of the Mannin European headquarters in Leipzig.'

Mannin is leveraging two distinct modes of action to reduce the intraocular pressure that causes glaucoma, utilizing different routes of administration and dosing regimens. Mannin is currently working on the preclinical development of a small molecule pharmaceutical eye-drop as well as a novel recombinant protein injectable biologic. This approach increases the probability of success of developing a new therapy that is optimized for the needs of glaucoma patients. Additionally, Mannin is exploring other therapeutic opportunities using these molecules for vascular diseases.

George Nikopoulos, President and CEO of Mannin, stated, 'We are very encouraged by the confidence and enthusiasm the government of Saxony has shown in our research, and we are committed to making accelerated progress through their investment.'

Q BioMed and Mannin intend to announce further details regarding the research program later this year.

About Q BioMed Inc: Q BioMed Inc. is a biotech acceleration and commercial stage company. We are focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q BioMed is dedicated to providing these target assets; strategic resources, developmental support, and expansion capital to ensure they meet their developmental potential, enabling them to provide products to patients in need‏."

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Johnson & Johnson (NYSE: JNJ) believes good health is the foundation of vibrant lives, thriving communities and forward progress. Last year, Johnson & Johnson Vision,The Singapore National Eye Centre (SNEC), and the Singapore Eye Research Institute (SERI) announced a USD 26.35 Million (SGD 36.35 Million) research collaboration to tackle myopia, or nearsighted vision, the largest threat to eye health this century. By 2050, half of the world's population are projected to be myopic, with one billion expected to have high myopia, a severe state of the condition that can lead to retinal disease with an increased risk of blindness. The first-of-its-kind public-private strategic partnership in Asia focused on myopia will create a deeper understanding of how the condition develops, how it progresses and how it may be intercepted. It will focus on developing predictive tools to identify those who may be at risk to develop high myopia, conduct research on the underlying mechanisms of myopia, progress novel therapies, and discover and validate methods to prevent the onset and progression of the condition. Myopia is the number one eye defect in the world. Myopia increases risk of retinal degeneration and detachment, cataracts and glaucoma. Unchecked, it will become the leading cause of irreversible vision impairment and blindness. The condition occurs when the eyeball becomes elongated due to environmental and genetic factors.  Few modalities are currently approved by regulatory bodies to control myopia. "The incidence of myopia is increasing at an alarming rate around the world and if left unchecked, the human and financial toll could skyrocket in the coming decades, especially in Asia," said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. "We are delighted to be collaborating with SERI and SNEC to better understand the underpinnings of this condition and identify ways to halt this global public health threat. Together, we hope to bring important progress to individuals and families throughout the Asia Pacific region and ultimately, around the world."

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical leader focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Allergan plc recently announced that the U.S. Food and Drug Administration (FDA) had accepted the company's New Drug Application (NDA) for Bimatoprost Sustained-Release (SR). Bimatoprost SR if approved would be the first-in-class sustained-release, biodegradable implant for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. The FDA is expected to take action on the NDA by the end of the first half of 2020. "With decades of experience researching and introducing innovative eye care treatments, we understand the importance of developing new and potentially sight-saving treatments for patients with glaucoma," said David Nicholson, Chief Research and Development Officer, Allergan. "The NDA is based on the positive results from the ARTEMIS Phase 3 studies and demonstrates our ongoing commitment to providing new treatments for patients living with glaucoma."

Bausch Health Companies Inc. (NYSE: BHC) is a global company whose mission is to improve people's lives with its health care products. Bausch + Lomb, a leading global eye health company and wholly owned subsidiary of Bausch Health previously announced that on December 27th, 2018, Health Canada issued a Notice of Compliance (NOC) for VYZULTA™ (latanoprostene bunod ophthalmic solution, 0.024%). VYZULTA™, the first prostaglandin analog with one of its metabolites being Nitric Oxide (NO), is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. VYZULTA™ is the first new innovative treatment for open-angle glaucoma in Canada in almost twenty years. VYZULTA™, the first once daily monotherapy with a dual mechanism of action, which targets two pathways to reduce aqueous humor to lower IOP. Following topical administration, VYZULTA™ is thought to lower intraocular pressure by increasing outflow of aqueous humor through both uveoscleral and trabecular meshwork routes.iii The innovative treatment is rapidly metabolized in the eye to latanoprost acid (main active metabolite), an F2α prostaglandin analogue, and likely butanediol mononitrate.iv "More than 250,000 Canadians have glaucoma, which is a chronic disease that results in vision loss over time. Ninety percent of all glaucoma cases are primary open-angle glaucoma (POAG)," says Richard Lajoie, President, Bausch Health, Canada. "With today's approval of VYZULTA™, doctors and patients with glaucoma now have a new innovative treatment option that can help provide consistent and sustained IOP reduction. High IOP is the only modifiable risk factor that can help slow down the progression of the disease to help patients maintain healthy vision."

Aerie Pharmaceuticals, Inc. (NASDAQ: AERI) is an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, retinal diseases and other diseases of the eye. Aerie Pharmaceuticals, Inc. announced earlier this year that the U.S. Food and Drug Administration (FDA) had approved Rocklatan™ (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Rocklatan™ is a once-daily eye drop that is a fixed-dose combination of latanoprost, the most widely-prescribed prostaglandin analog (PGA), and netarsudil, the active ingredient in Rhopressa® (netarsudil ophthalmic solution) 0.02%, a first-in-class Rho kinase (ROCK) inhibitor specifically designed to target the trabecular meshwork (the eye's principal drainage pathway). The diseased trabecular meshwork is considered to be the main cause of elevated IOP in open-angle glaucoma and ocular hypertension. Rhopressa® works by restoring outflow through the trabecular meshwork, while latanoprost increases fluid outflow through a secondary mechanism known as the uveoscleral pathway. "We are in the unique position of receiving FDA approval on a second glaucoma treatment less than a year from the U.S. launch of Rhopressa®," said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie. "Together, Rocklatan™ and Rhopressa® give us a broad therapeutic franchise, based on our ROCK inhibitor netarsudil, that addresses many of the needs of clinicians and patients in a wide variety of treatment settings. Our existing salesforce, which has been calling on U.S. eye-care professionals since last May, is very well positioned to introduce Rocklatan™ to these doctors and help them understand the clinical utility of both products in the care of their patients with glaucoma. We have also been working diligently on securing favorable reimbursement for our products, with Rhopressa® now enjoying broad commercial and Medicare Part D coverage, and Rocklatan™ already under review by major payers."

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