Biotechnology Companies See Growth in Optic Treatment Sectors

NEW YORK, Feb. 6, 2019 /PRNewswire/ -- The vast number of people in need of medical treatment has grown tremendously over the years. Some cases are a result of environmental changes, yet others can be caused by genetics. Regardless, there is a growing demand within the biotechnology market for treatments to effectively eliminate or suppress these conditions. Based on a technological application, the biotech market is split into many sectors, such as PCR technology, chromatography, DNA sequencing, nanobiotechnology, tissue engineering and regeneration. Despite the numerous sectors within the industry, each is witnessing strong demand. According to data compiled by Variant Market Research, the global biotechnology market is expected to reach USD 726.8 Billion by 2025. Furthermore, it is expected to grow at a CAGR of 8.1% from 2017 to 2025. Primarily, the increasing demand for therapeutic and diagnostic solutions on principles of red biotechnology, recombinant technology and DNA sequencing, is expected to drive the overall industry. Q BioMed Inc. QBIO, Novartis AG NVS, Aerie Pharmaceuticals, Inc. AERI, Axsome Therapeutics, Inc. AXSM, Verastem, Inc. VSTM

One market within the biotechnology marketplace, in particular, has come into focus: the ophthalmic segment. Ophthalmic or ocular drugs are mainly used to treat eye conditions such as cataract, retinopathy, and glaucoma. The global ophthalmic market was valued at USD 25.03 Billion in 2017 and is expected to generate approximately USD 34.52 Billion by the end of 2024. Additionally, it is expected to grow at a CAGR of 4.7% as companies involved in the sector are introducing new ocular drugs into the market to effectively treat ophthalmic disorders. Glaucoma is among one of the leading segments within the ocular drug market. According to research by BrightFocus Foundation, more than 3 million Americans live with glaucoma and it is one of the leading causes of irreversible blindness in the world. "Glaucoma is a vision-threatening disease that requires lifelong treatment and patient compliance," said Alice T. Epitropoulos, MD, FACS, OSN Cataract Surgery Board Member. "Ophthalmology is on the cusp of entering a new golden era of innovation for the treatment of glaucoma with promising and novel therapies in clinical development that have the potential to address concerns with patient compliance, increased efficacy and potentially preserve sight for glaucoma patients."

Q BioMed Inc. QBIO earlier last month announced breaking news that, "Its technology partner, Mannin Research, has initiated a collaboration with McMaster University of Ontario, Canada. The collaboration is focused on ophthalmic drug delivery and formulation experiments for MAN-01, a first-in-class small molecule to treat Primary Open-Angle Glaucoma. Experiments will be conducted Dr. Heather Sheardown, a world renowned thought leader in ophthalmic biomaterials and drug delivery."

CEO of Mannin Research, Dr. George Nikopoulos stated, "This collaboration is extremely important for us and Q BioMed, as well as the MAN-01 program. The Sheardown lab at McMaster University specializes in ophthalmic delivery systems. As we approach our Phase I clinical trial, having the renowned expertise and experience of Dr. Sheardown and her team working with us on delivering our small molecule candidates to the eye is important to our success."

The main objective of the collaboration is to explore novel and better ways of delivering Mannin's small molecules to the eye to treat glaucoma. Using the formulation and drug delivery expertise of the Sheardown laboratory, the collaboration partners are focusing on increasing the compounds' ability to lower intra-ocular pressure to more effectively treat glaucoma.

Q BioMed, CEO, Denis Corin commented, "Through this collaboration, we are also exploring the use of extended and sustained release formulations with the Mannin compounds for the treatment of other vascular related diseases, such as acute kidney injury, influenza, and myocardial ischemia. We expect the ophthalmic drug delivery data from this collaboration will inform our planned Investigational New Drug (IND) application with the U.S. FDA."

About Dr. Sheardown: Dr. Heather Sheardown holds a Tier 1 Canada Research Chair for Ophthalmic Biomaterials and Drug Delivery Systems. She is an expert in drug delivery, contact lens materials, (intraocular lenses) IOLs, polymer chemistry, and bioengineering in the ophthalmic space. Dr. Sheardown is a Professor in Chemical Engineering and the School of Biomedical Engineering at McMaster University and is cross-appointed with the School of Optometry at the University of Waterloo.

Dr. Sheardown has gained an international reputation for her research on ophthalmic biomaterials, including her innovative work on the development of new materials for contact lenses and drug delivery applications. She has published more than 150 papers in top biomaterials journals, numerous book chapters on ocular materials and drug delivery and has several patents and patents pending on various ophthalmic materials. She has worked extensively with major ophthalmic materials companies including Vistakon, CIBA Vision, Coopervision and AMO, and is the Chief Scientific Officer for a spin-out company, 20/20 OptimEyes Technology.

Dr. Sheardown has an active and vibrant research group of more than 10 graduate students and post-doctoral fellows. Projects in her laboratory involve the development of new polymeric materials and delivery systems for all areas of the eye. These projects are currently supported by C20/20, an Ontario Research Fund grant. This grant is enabling the commercial development of academic-derived technologies and supporting partnerships with corporate partners with co-development opportunities.

About Q BioMed Inc: Q BioMed Inc. 'Q' is a biomedical acceleration and development company. We are focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q 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."

For our Exclusive Interview with CEO Denis Corin of Q BioMed Inc. Live from NASDAQ Marketsite please head over to: https://www.youtube.com/watch?v=ZsmRFGNBeI8

Novartis AG NVS is reimagining medicine to improve and extend people's lives. Recently, Novartis announced a new data analysis showing that retinal fluid was detected less often in patients treated with brolucizumab (RTH258) 6 mg versus aflibercept over four visits between weeks 36 to 48[1]. Retinal fluid is a key marker of disease activity in neovascular age-related macular degeneration (nAMD)[2]. The data, from pre-specified secondary endpoints of the Phase III HAWK and HARRIER trials, were presented at EURETINA 2018 as a follow-up to data presented in November 2017. "Retinal fluid is an important marker of disease activity and the need for treatment. These new data give physicians even more insight into the robustness of the 48 week anatomical findings and support the overall impact brolucizumab has on key measures of retinal fluid, including IRF/SRF, sub-retinal pigment epithelial fluid and central subfield thickness," said Dirk Sauer, Development Unit Head, Novartis Ophthalmology. "These results were noted even while more than half of brolucizumab 6 mg patients were receiving treatment every 12 weeks at week 48, further reinforcing our confidence in brolucizumab's superior fluid resolution and supporting our goal of reimagining care for people with nAMD."



Aerie Pharmaceuticals, Inc. 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, retina diseases and other diseases of the eye. Aerie Pharmaceuticals, Inc. recently announced that the U.S. Food and Drug Administration (FDA) has reviewed the Investigational New Drug Application (IND) for AR-1105 (dexamethasone intravitreal implant) and it is now in effect, allowing Aerie to initiate human studies in the treatment of macular edema due to retinal vein occlusion (RVO). The IND was submitted in December 2018. Aerie expects to initiate a Phase 2 clinical study later in the first quarter of 2019. AR-1105 is a bio-erodible implant that is designed to release the steroid dexamethasone over a six-month sustained period. The method of administration is through commonly used intravitreal injection. The potential benefits of AR-1105 compared to other steroid products include six-month duration of efficacy, improved administration due to a smaller needle size, and possibly a better safety profile due to lower peak drug levels. "AR-1105 is the first IND-stage treatment in Aerie's retina pipeline, which is an important milestone for the company," said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie. "This quarter we also plan to file an IND for our second retina product, a bio-erodible implant containing the Rho kinase/Protein kinase C inhibitor AR-13503 that is being developed for wet age-related macular degeneration and diabetic macular edema. These products demonstrate the potential of our two enabling platforms for delivering drugs to the back of the eye, the bio-erodible polymer technology we licensed from DSM and the PRINT® manufacturing technology licensed from Envisia. As we advance these new treatments in our second significant therapeutic area in eye care, we continue to pursue our goal of building the next major ophthalmic pharmaceutical company."

Axsome Therapeutics, Inc. AXSM is a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders for which there are limited treatment options. Recently, Axsome Therapeutics, Inc. has initiated the CONCERT (Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment) study, a Phase 2, randomized, controlled trial of AXS-12 (reboxetine) in narcolepsy. AXS-12 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. Topline results from the CONCERT trial are expected in the second quarter of 2019. "The initiation of the CONCERT trial of AXS-12 for the treatment of narcolepsy reflects Axsome's advancing pipeline of differentiated CNS product candidates, and our continued commitment to developing novel medicines to improve the lives of patients living with serious and difficult-to-treat CNS disorders," said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. "The CONCERT trial utilizes an efficient crossover design to improve signal detection and speed trial conduct. We look forward to topline results from this study in the second quarter of this year." 

Verastem, Inc. VSTM is a commercial biopharmaceutical company committed to the development and commercialization of medicines to improve the lives of patients diagnosed with cancer. Verastem, Inc. recently announced a poster presentation of preclinical data by Jonathan Pachter, Ph.D., the Company's Chief Scientific Officer, at the Society for Immunotherapy of Cancer's (SITC) 33rd Annual Meeting being held November 7-11, 2018, in Washington, D.C. "We have assessed the activity of duvelisib, our orally-administered dual inhibitor of PI3K-delta and PI3K-gamma, in combination with either immune checkpoint or co-stimulatory antibodies in syngeneic antitumor models," said Dr. Pachter. "Results to be presented at SITC's 33rd Annual Meeting demonstrated that duvelisib shows strong anti-tumor synergy with PD-1 or OX40 antibodies. As a dual PI3K-delta/gamma inhibitor, duvelisib was found to reduce both immunosuppressive Tregs and myeloid cells in tumors more strongly than PI3K-delta, or PI3K-gamma only inhibitors, suggesting that it could be a highly-differentiated PI3K inhibitor for combination with immuno-oncology therapeutics. These preclinical results support clinical investigation of duvelisib in combination with immunotherapies for treatment of patients with hematological or solid tumor malignancies."

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