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Dr. Mali’s Top 5 Predictions for 2018

This is an article by Dr. Joshua Mali published by Ophthalmology Times.

1). Aflibercept and ranibizumab utilization will continue to soar to new heights in 2018.

The success of aflibercept (Eylea, Regeneron Pharmaceuticals) and ranibizumab (Lucentis, Genentech/Roche) injections will definitely continue in 2018. Regeneron just recently reported fourth-quarter 2017 sales of its flagship product, aflibercept, of $975 million, up 13.6% year over year. I anticipate sales will continue to flourish with aflibercept given its strong efficacy data and excellent long-term safety profile.

In 2017, ranibizumab became the first anti-VEGF therapy approved to treat patients with myopic choroidal neovascularization (mCNV) in the United States, in addition to receiving FDA approval for the treatment of all forms of diabetic retinopathy. The combination of these two new indications, as well as the availability of the ranibizumab 0.5-mg prefilled syringe, makes ranibizumab primed to continue its growth momentum in 2018. Overall, as the prevalence of exudative age-related macular degeneration (AMD), retinal vein occlusion, and diabetic macular edema continues to climb worldwide, these will be the two heavyweights in the anti-VEGF market in 2018.

2). The ForeseeHome device will be the new standard of care in AMD monitoring.

Described in one of my previous articles as one of the 5 greatest ophthalmic innovations of the 21stcentury, telemedicine represents a new frontier of our field focusing on two main principles: prevention and early disease detection. This philosophy is probably best illustrated in a disease like AMD, and the ForeseeHome device (Notal Vision) is the flagship telemedicine technology in ophthalmology today. The ability to immediately detect the initial conversion in a patient from dry to wet AMD is absolutely critical and basically determines a patient’s visual prognosis in addition to making our current therapies even more effective. Top that off with the recent Medicare coverage approval for the device and I believe ForeseeHome utilization will accelerate this year and become the new standard of care in AMD monitoring.

 3). Bromenfac will take a significant leading share of the topical NSAID market.

Bromfenac ophthalmic solution 0.075% (BromSite, Sun Ophthalmics) is a non-steroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery. Bromfenac is the active molecule that is designed for improved corneal penetration given the bromine component which allows for enhanced lipophilicity and ocular tissue penetration. However, the key feature of this medication is the delivery system (DuraSite) that allows the delivery vehicle to be more viscous and mucoadhesive—thus increasing retention time on the ocular surface and allowing for a higher intraocular concentration of bromfenac. I strongly believe that bromfenac, with its delivery vehicle, is able to create a much higher intraocular concentration (as compared with other topical NSAIDs)—thus resulting in a more efficacious response and will lead to increased utilization in the ophthalmology community in 2018.

4). Voretigene neparvovec-rzyl will be a successful pioneer for gene therapies. 

Voretigene neparvovec-rzyl (“voretigene,” Luxturna, Spark Therapeutics) is the first gene therapy for a genetic disease, first and only pharmacologic treatment for an inherited retinal disease (IRD), and first adeno-associated virus (AAV) vector gene therapy approved in the United States. With all these first-in-class titles, there will be new challenges ahead for this innovative advance in medicine. Drug cost reimbursement, insurance coverage, distribution, and marketing/education will be the critical topics that will require creative solutions.

However, I believe voretigene is more than ready for the battle and it will be very successful in pioneering this new frontier. The company has already put into motion an organized structural model to address these pivotal issues and they have the skills to deliver this exciting new treatment to patients across our country. They will be making history and writing the blueprint for which the entire class of gene therapies will utilize in the future.

5). Healthcare law reform will start to take shape.     

While complete healthcare reform has taken a backseat to other legislative priorities, I still strongly believe comprehensive healthcare reform will make significant progress in 2018. While it remains to be seen if complete repeal of the Affordable Care Act (ACA) or adjustment to existing healthcare law will be accomplished and signed into law this year, President Trump and Congress will be working diligently on a solution for healthcare reform.

In addition, the private sector may also be able to provide some assistance in developing healthcare solutions.

For example, it was recently announced that Amazon, Berkshire Hathaway, and JPMorgan Chase & Co. are partnering on ways to address healthcare for their U.S. employees, with the aim of improving employee satisfaction and reducing costs.

Additionally, former CMS administrator Andy Slavitt has launched a new bipartisan nonprofit organization called the United States of Care to ensure access to quality, affordable health care for all Americans regardless of health status, social need or income.

Ultimately, it will take the efforts of all of us as Americans with different backgrounds and skills to solve this issue. I also have some ideas on how to develop our healthcare policy that will be satisfactory to all sides-patients, physicians, hospitals, pharmaceutical companies, insurance companies, and our government. So, if President Trump, any of our politicians from Congress, or members of these private sector initiatives are reading this article, feel free to call me. That being said, we must have stabilization of the United States healthcare system in order to allow all of us as physicians/ophthalmologists to continue to provide the best healthcare delivery for our patients.

2018 will definitely be a very exciting year for both ophthalmology and healthcare as a whole. As I have done in the past, I look forward to keeping you updated throughout the year!

Joshua Mali, MD, is a board-certified ophthalmologist and award-winning vitreoretinal surgeon at The Eye Associates, a private multispecialty ophthalmology practice in Sarasota, Florida. He can be reached at 941-923-2020. Dr. Mali’s relevant financial disclosures include the following: Regeneron (consultant, speaker, stock shareholder, research funding), Genentech/Roche (consultant, speaker), Notal Vision Inc. (consultant, speaker), and Sun Pharmaceutical Industries Inc. (consultant, speaker).

Important Reason for Eye Exams – Safety

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Happy Mom with daughter and granddaughter.

Safety as we age is the most important thing. We all worry about the safety of our parents. Poor vision can have many adverse effects, such as depression, car accidents, and medication errors, but none of these are more concerning than a fall. Falls are among the leading cause of death for people age 65+, and people with low vision are at even greater risk. Reduced contrast, decreased depth perception, and a reduced field of vision can inhibit balance and the ability to detect obstacles. Increased safety is one of the most compelling reasons to have an annual eye exam.

Visual Factors That Impact Falls

Reduced field of vision – Objects that cannot be seen are a common cause of falls. Eye diseases such as Glaucoma, Macular Degeneration and Diabetic Retinopathy can rob one’s vision. Glaucoma affects ones peripheral vision, while Macular Degeneration and Diabetic Retinopathy can cause blind spots in the central vision.
Reduced depth perception – People with vision in just one eye may have problems judging distances, making it more dangerous to negotiate obstacles.
Reduced contrast sensitivity – Reduced vision also causes reduced contrast making obstacles and clutter hard to see. Curbs become nearly invisible and many objects can fade into the background.

Eye Exams Save Sight and Increase Safety

Increased safety is one of the most compelling reasons to have an annual eye exam. Did you know that some eye diseases do not have warning signs, and many can only be detected with a dilated eye exam. Cataracts can affect sight so gradually that you don’t notice the decreased vision. And half of all people with glaucoma are unaware that they even have the disease. Also, diabetics with diabetic retinopathy often do not experience symptoms when the disease is at its most treatable stage. The key to keeping good vision starts with the early detection and treatment.

Call 1-866-865-2020 or click here for a comprehensive eye exam today!

Blindness – a Major Fear


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Blindness causing fear of losing the active lifestyle that you now enjoy.

Blindness – Third Biggest Fear

A Prevent Blindness America Survey found that blindness ranked third as a major fear. Number 1 and 2 were cancer and heart disease. Of course, there are ways to prevent vision loss. The best way is to have a yearly comprehensive dilated eye exam. Being proactive always has positive benefits on your health and your eye health.

Common Causes of Blindness

Cataracts are the leading cause of preventable blindness worldwide. Cataract surgery is a very common surgery in the United States, but in less developed countries, people often go blind. This is due to the inaccessibility of eyecare. But even here in the US, we find that since cataracts are slow growing and they usually affect the vision in such a gradual way. Often people are unaware they have them and don’t realize they have such poor vision.

Diabetic retinopathy is another common cause of blindness in people under age 65. Diabetes affects your entire body, including your eyes. According to The American Academy of Ophthalmology, diabetics are 25 times more likely to lose vision than those without this disease. Diabetic retinopathy is the most common complication of diabetes. The longer you have diabetes, the more likely it is that you’ll develop diabetic retinopathy.Many patients with this condition are asymptomatic at its most treatable stage, so diabetics are strongly advised to have routine yearly comprehensive dilated eye examinations.

Another cause of vision loss is glaucoma. Half of all people with glaucoma risk permanent damage because they are unaware that they have it. A comprehensive dilated eye exam is the only way to determine whether these problems are present so appropriate treatment can be initiated.

As you can see, serious and sight-threatening eye diseases do not always present symptoms, but they can be diagnosed during a eye exam. Often treatment can be given before damage occurs. Vision is your most valued of all senses, for everyday activities and even your safety. An eye exam should be part of your yearly schedule. It could save your sight!

Click here or call 1-866-865-2020 for a comprehensive eye exam with one of our Board Certified Physicians.

8 Warning Signs of Serious Eye Problems



Early detection is key to saving sight.

8 Warning Signs of Serious Eye Problems

It is important to catch serious eye problems early in order to preserve vision. Your sight is one of your most precious senses. Maintaining healthy eyes should be a priority.  How do you know if an eye problem is the start of something serious? We hope this guide helps you identify problems that can’t wait.

If you experience any of the following symptoms of a serious eye problem, call your eye doctor immediately.
1) A sudden decrease in vision in one eye.
This could indicate a problem with the retina; perhaps a macular hole. The chance of this happening increases as we age, and women are at higher risk than men.

2) A flood of spots, floaters or debris in the eye or a dark curtain across your field of vision.
Most floaters are benign, but if you experience a sudden onset, it could indicate a retina problem, such as a tear or retina detachment. If it is a retinal detachment, it needs to be treated immediately. If left untreated, vision loss can be permanent.

3) A gradual loss of central vision and distortions when looking at straight lines.
Macular Degeneration is the leading cause of blindness among older Americans, with central vision loss as a common symptom. Dry Macular Degeneration can turn into Wet Macular Degeneration overnight. That is why every senior should test their eyes daily with an Amsler Grid. It is important to do the test one eye at a time. Click the following link to print out your FREE Amsler Grid.

4) Loss of peripheral vision.
This symptom is hard to notice and could mean that you are developing glaucoma. The loss happens so slowly that many times it is not noticed until damage is done.

5) A sudden onset of eye pain, nausea, vomiting, and redness.
These symptoms could indicate an attack of narrow-angle glaucoma that can permanently damage your optic nerve and vision.

6) Double vision or ‘ghost like’ images.
Double vision can be related to many eye problems, and even other health conditions such as strokes. We recommend that you take immediate action and see a doctor.

7) Scratchy, irritated, watery eyes.
Frequently these symptoms indicate Dry Eye Disease. There is no cure for it but there are many treatments. If left untreated, loss of vision and serious eye problems could occur in extreme cases.

8) If you are diabetic and have blind spots, accompanied by floaters and blurred vision.
This could definitely indicate the onset of diabetic retinopathy. Daily use of  an Amsler Grid is recommended for this as well.

Another common condition that is not an emergency or serious eye problem: Cataracts
‘Halos’  around lights and cloudy, blurry vision.
Cataracts could be the cause here. Luckily cataract surgery is quite commonplace these days and can quickly return good vision.

Saving sight is our most important mission at The Eye Associates!  Should you or someone you know experience one of the symptoms serious eye problems above and vision loss, call immediately 1-866-865-2020. After business hours, our answering service will contact the doctor-on-call for emergencies.

NEW Sight Saving Test for Dry Macular Degeneration Patients

Do you have dry age-related macular degeneration (AMD)?

The Notal Vision Home monitoring device for dry AMD patients.

Foresee Home AMD Monitoring Program

Studies show that up to 43% of dry macular degeneration patients progress to wet AMD. The progression can be so subtle that you may not even notice it at first. Since our brain can compensate for poor vision in one eye by filling in missing areas, often new visual distortions from wet macular degeneration are missed.

Wet Macular Degeneration

Wet AMD occurs when blood vessels in the eye start to bleed. This causes damage to the macula in the retina. Luckily there are effective treatments for wet AMD, but the success of these treatments depends on early detection and treatment.

The Eye Associates has always recommended that macular degeneration patients do a daily vision check at home with a amsler grid. It a simple way to detect vision changes that occur when dry macular degeneration becomes wet. Now there is a high-tech version of the amsler grid that can detect changes earlier so treatment can be started earlier. The ForeseeHome is the first FDA-cleared home monitoring device that is clinically proven to detect even the smallest changes in your vision.

This simple 3 minute test  that you do in the comfort of your own home detects early changes in your vision. You test one eye at a time by looking into the Foresee Home device. When used daily, ForeseeHome detects changes before you notice them yourself. This allows you and your doctor to monitor your vision for any changes between eye exams. Monthly reports are sent directly to your doctor and any changes will be an indication that you need to be seen immediately.

Click here  to view a video about Foresee Home.

How to get the Forsee Home

If you are interested in getting a Foresee Home, contact The Eye Associates. Your doctor will write an order for the device. Notal Vision, the maker of the Forsee Home, will contact you for your insurance information. Insurance will usually cover the cost. The device will then be shipped to your home with instructions on how to set it up, as well as a help line phone number. You do not need a computer to use it. It can be used with wi-fi, cellular service and a landline.

Remember early detection is key in saving sight. Call 1-866-865-2020 for more information.