In order to fast-track approval of its new products, AXIM® Biotechnologies, Inc., a Medical Marijuana, Inc. investment company, has retained the services of Ora®, Inc. for the development of its cannabinoid-based eye treatments.
A global Contract Research Organization (CRO), Ora® will use AXIM®’s intellectual property to perform the company’s upcoming product development and clinical trials to create a new treatment option for glaucoma and dry eye.
“It is exciting to see AXIM start on pre-clinical efforts alongside esteemed ophthalmology professionals to develop a cannabinoid based eye drop medication that may assist glaucoma sufferers,” said Dr. Stuart Titus, CEO of Medical Marijuana, Inc. “This partnership between AXIM and Ora is another new exciting milestone for AXIM’s clinical development program, as it continues to move forward finding cannabinoid-based solutions for conditions for which there is no effective treatment.”
Ora® is the world’s leading ophthalmology CRO for accelerating products from research and development through regulatory approval and into product marketing, helping AXIM® Biotechnologies to streamline the process to bring its ocular care products to market.
“We are thrilled Axim selected Ora to be their development partner. The experienced ophthalmic teams at Ora look forward to maximizing the therapeutic potential of Axim’s technology for the benefit of patients suffering from glaucoma and dry eye,” said Ora’s President and CEO, Stuart B. Abelson.
The clinical programs will be conducted by Ora® under the supervision of Professor Robert Ritch, a world-renowned expert in ophthalmology and glaucoma. Prof. Ritch, the Surgeon Director Emeritus and Chief of Glaucoma Services at New York Eye and Ear Infirmary of Mount Sinai School of Medicine in New York, joined AXIM®’s Advisory Board in December 2016.
Glaucoma, recognized as the second leading cause of blindness in the world by the WHO, is a complex disease in which increased intraocular pressure from fluid buildup leads to damage of the optic nerve, causing progressive, irreversible vision loss.
It is estimated that over three million Americans suffer from glaucoma. On a global scale, an estimated 3 percent of all adults over age 40 have glaucoma. This is significant due to the high costs of treatment. Surgery options to treat glaucoma can run as high as $11,000 or more, and global spending on glaucoma management in 2016 was $6 billion.
Symptoms of glaucoma include halo effects around light sources, blurred vision, tunnel vision, and cloudiness of the eye. Because it is degenerative, early treatment of glaucoma is critical to managing the condition. Glaucoma most often affects those 40 or older, but it can also affect children and young adults. Detecting glaucoma early is just one of the reasons it is suggested everyone receive a full eye exam every 1-2 years.
“Over three million Americans have glaucoma, which is the second leading cause of blindness in the world, according to the World Health Organization,” Dr. Titus continued. “We anticipate this partnership to enhance AXIM’s glaucoma and xerophthalmia (dry eye) products development, ultimately improving the well-being of patients across the globe who suffer with these conditions. At this time, it is anticipated that initial development and early stage trials will be performed in Europe but Ora, Inc. will be pushing to receive DEA approval for U.S. trials once the clinical development leads to human trials.”
Glaucoma is not yet curable, and vision lost cannot be regained. However, with medication, eye drops, traditional surgery, or laser surgery, it is possible to halt further loss of vision in some patients.
Also in development by AXIM® Biotechnologies is a treatment for dry eye. Dry eye is a condition where a person fails to produce enough quality tears to lubricate and nourish the eye. This drying results in symptoms of discomfort and tear film instability that can ultimately lead to ocular surface damage. Causes of dry eye can be from the natural aging process, as a side effect of some medications, and even as symptoms of diseases like rheumatoid arthritis and Sjogren’s syndrome. Commonly, glaucoma treatment can cause dry eye in certain patients.
Dry eye is often a chronic problem, particularly in older adults, and is expected to become even more prevalent with the aging population and the increased use of video display terminals such as computers and smartphones. Dry eye can be treated in a number of ways, including the introduction of artificial tears, increasing natural tear production, or preservation of existing tears. The dry eye market is expected to grow to $4.5 billion by the year 2020.
“Despite new product approvals, glaucoma and dry eye remain ophthalmic diseases with significant unmet medical needs. Approximately 40% of glaucoma patients require more than one IOP-lowering medication. We hope that the development of new treatments with novel mechanisms of action will in turn reduce the risk of progression of visual field loss,” said David A. Hollander, MD, MBA, Chief Medical Officer of Ora. “Dry eye is one of the leading reasons for patient visits to eye care specialists. Novel therapies that address the signs and symptoms of dry eye disease will be welcomed by both dry eye sufferers and physicians.”
This partnership with Ora®, Inc. will allow AXIM® Biotechnologies to continue to tackle hard to treat conditions with novel new cannabinoid-based medications. Stay up to date with developments Medical Marijuana, Inc.’s investments by following our news feed.