Joshua Mali, MD

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Editor’s Note: Welcome to “Eye Catching: Let's Chat,” a blog series featuring contributions from members of the ophthalmic community. These blogs are an opportunity for ophthalmic bloggers to engage with readers with about a topic that is top of mind, whether it is practice management, experiences with patients, the industry, medicine in general, or healthcare reform. The views expressed in these blogs are those of their respective contributors and do not represent the views of Ophthalmology Times or UBM Medica. This is part two of a three-part Clinical Innovations series discussing the benefits of incorporating an at-home monitoring system for patients with AMD. Joshua Mali, MD, is a vitreoretinal surgeon at The Eye Associates, a private multispecialty ophthalmology practice in Sarasota, FL.

Early detection, followed by immediate treatment, is key to achieving the best possible outcomes for patients with wet age-related macular degeneration (AMD).

Therefore, monitoring these patients to detect the progression from dry to wet AMD is integral to preserving their vision. Due to the fact that patients are more likely to convert to wet AMD between scheduled follow-up appointments with their primary eye-care physician, home monitoring is a valuable extension of in-office clinical care that allows us to detect wet AMD at the earliest possible moment.

This permits earlier treatment of a less-aggressive disease, potentially reducing the intravitreal injection treatment burden and dramatically improving visual outcomes. Aside from the obvious visual acuity benefit, at-home monitoring can also alleviate patients’ anxiety about their disease, as they find comfort knowing that I am watching and monitoring their AMD on a daily basis.

There are currently two methods to monitor vision outside the clinic. One is the Amsler grid, the current standard of care, that is essentially a straight-lined piece of paper with a fixation point in the center. The efficacy of the Amsler grid has been called into question often, given that its sensitivity varies from patient to patient and even from test to test.

Given all our 21st-century advances in technology and medicine, it is time for our technology to revolutionize the way we monitor a disease like AMD. Therefore, a more advanced technology, preferential hyperacuity perimetry (PHP), is now available in a device (ForeseeHome, Notal Vision).

The device was found to be so effective that the clinical trial to demonstrate its efficacy ended early given such a positive impact on visual outcomes in AMD patients.

In addition, the device can relieve patients’ anxiety as they find comfort knowing that an objective, highly sensitive device is monitoring their vision regularly and will detect changes in their vision and alert me directly if needed.

Increased efficacy of chair time and patient monitoring

The data reports from the device allow me to streamline patient visits and focus on any alerts and concerns. My patients use the device a minimum of eight times per month (although daily use is encouraged) and I check each report once a month. If the patient gets an alert or if I see something of concern during my routine clinical examination, I can cross-reference the report to my clinical exam findings to help me manage individual care appropriately. These reports are a helpful adjunct to optical coherence tomography (OCT) and other standard in-office clinical techniques and diagnostic imaging tools.

Prior to the device, the only options we had to monitor and treat dry AMD was the Amsler grid, AREDS2 vitamins, a good diet, regular exercise, utilizing sunglasses, and cessation of smoking. When one is considering the Amsler grid, it is possible to run into significant patient compliance issues. Often, patients may forget to use the grid or do not use it correctly. This has made it difficult for me to truly know if my patients are effectively monitoring their vision at home.

This device produces reports that display data and information about the patients’ proper usage of the device and records how frequently they are testing, thus allowing me to have the ability to analyze their individualized compliance rates with them at appointments.

There are several advantages to the strategy of more frequent at-home monitoring with the device. As patients test with greater frequency, the algorithm becomes more fine-tuned and accurate, which can allow an increase in the likelihood that choroidal neovascularization (CNV) is discovered at the earliest possible moment. Of note, while the device has received Medicare coverage, there is a requirement through Medicare that the patient must use the device at least eight times per month or they will have to return it due to non-compliance. This provides a major incentive to use the device regularly and consistently. As a result, traditional patient compliance issues are therefore typically minimized.

Alerts that do not detect a conversion to wet AMD (“non-CNV alert”) are generally not an issue. Overall, I have had less than five patients with a non-CNV alert, and with more than 100 of my patients actively testing on the device, this represents a relatively insignificant factor given the overall benefit. When an alert does occur, my office will contact the patient and schedule a follow-up visit typically within 24 to 48 hours.

Once the patient comes into the office, he or she is given a full dilated ophthalmic examination of both eyes including an optical coherence tomography (OCT) scan and fluorescein angiogram (FA). If there is no evidence of CNV, then I can conclude that the alert was a non-CNV alert.
When this is the case, I typically still bring the patient back for a follow-up examination in about four weeks as I am aware of cases in the clinical trial where the device had alerted, but pathology was subclinical and therefore not immediately detectable until later when there was more clinical progression. I take these device alerts very seriously and keep a close eye on any patient who has a non-CNV alert, although, to date, I have not yet had a non-CNV alert convert to a CNV lesion.

While some physicians may be hesitant to institute a new device into their clinical practice regimen–given that they may already feel overwhelmed in the clinic with current office logistics and concerns that a new technology will be an added burden¬–I have found and strongly believe that the benefits of prescribing the device far surpass any inconvenience. The company is helpful with all the logistics, including contacting patients to verify insurance/benefits, organize device delivery, training, troubleshooting, and general customer service. Given the role that the company plays, much of the burden is removed from the eye-care professional.

Ultimately, a physician’s job is to give our patients the best quality of care possible. If we have patients who are eligible to receive the device, they should be given the opportunity to learn more about it and be enrolled in the device program. The ideal candidates are intermediate dry AMD patients with a visual acuity of at least 20/60 in the testing eye. For those who do not meet the vision requirement or cannot baseline with the device, the Amsler grid is still a good choice to monitor these patients.

Joshua Mali, MD, is a board-certified ophthalmologist and award-winning vitreoretinal surgeon at The Eye Associates, a private multispecialty ophthalmology practice in Sarasota, FL. He can be reached at 941-923-2020. 

Dr. Mali is currently a consultant and speaker for Notal Vision, Inc.

Ho AC, Albini TA, Brown DM, et al. The potential importance of detection of neovascular age-related macular degeneration when visual acuity is relatively good. 

Achard OA, et al. Role of the Completion Phenomenon in the Evaluation of Amsler Grid Results. 

AREDS2-HOME Study Research Group, Chew EY, Clemons TE, Bressler SB, et al. Randomized trial of a home monitoring system for early detection of choroidal neovascularization home monitoring of the Eye (HOME) study. 

Articles

Home-use AMD device increases efficacy of chair time, patient monitoring  

,” a blog series featuring contributions from members of the ophthalmic community. These blogs are an opportunity for ophthalmic bloggers to engage with readers with about a topic that is top of mind, whether it is practice management, experiences with patients, the industry, medicine in general, or healthcare reform. The series continues with this blog by 

. The views expressed in these blogs are those of their respective contributors and do not represent the views of 

I am happy to announce a new initiative by the 

Macular Degeneration Association (MDA): AMD Centers of Excellence (COE)

. This program shares best-practice methods in disease evaluations and treatments. This age-related macular degeneration (AMD) COE will help patients locate outstanding treatment facilities in their area.

Founded in 2007, the MDA is a nonprofit health organization dedicated to educating and empowering patients with AMD. The MDA funds research, publishes scientific findings, and provides funding for 

. The association is also involved in advocating for scientific research and the rights of people with AMD.

As a keynote speaker for the organization, I have had the joy of participating in patient education programs. These programs allow AMD patients and their family/caretakers to take control of their disease through education.

Here are some of the highlighted criteria for an AMD COE with the MDA accreditation:

Completion and submission of the enrollment application.

Facility must operate business in compliance with all applicable federal and state licensure and regulatory requirements for the health and safety of patients.

Physicians treating AMD should be fellowship trained in retina, board certified in ophthalmology, and members in good standing of both 

American Society of Retina Specialists (ASRS)

Facility must contain space for equipment appropriate to the services designated on the enrollment application, facilities for hand washing, adequate patient privacy accommodations, and the storage of both business records and current medical records.

 - Facility should have all applicable diagnostic testing equipment available at the physical site such as a spectral-domain or 

, fundus photography, autofluorescence, fluorescein angiogram, and diagnostic testing equipment.

 - Testing equipment must be calibrated and maintained per equipment instructions and in compliance with applicable manufacturer’s suggested maintenance and calibration standards.

Each physician/facility should meet at least one of the following conditions:

- At a minimum, at least 30% of the practice should be AMD patients
	- Participate in a multicenter study investigating a new treatment for AMD
	- Lecture on AMD
	- Author a paper or publication on AMD

A current complete catalog of diagnostic equipment, including diagnostic testing equipment serial and registration numbers, must be maintained at the physical site and available to the MDA upon request.

All physicians must stay current on all new technology while offering these new services to their patients.

All physicians agree to have available the following medications: bevacizumab (

), and any new anti-vascular endothelial growth factor (VEGF)/similar medication approved by the 

Have technical staff on duty with the appropriate credentials to perform diagnostic tests. The physical facility must be able to produce the applicable federal or state licenses or certifications of the individuals performing these services.

All applications and submitted documentation will be reviewed by the MDA’s medical director for final approval as an AMD Center of Excellence.

In anticipation of retina specialists receiving a formal invitation to participate in this valuable patient resource, go to the MDA website, www.macularhope.org, for more updates and information.

Look for clues to simplify anterior uveitis diagnosis


	E: malienterprisesglobal@gmail.com
	P: 941-923-2020
	

the founder & CEO of Mali Enterprises. His relevant financial disclosures include the following: speaker, consultant, and medical director of the Macular Degeneration Association (MDA).

The MDA is a nonprofit health organization dedicated to educating and empowering patients with AMD.

Macular Degeneration Association unveils AMD Centers of Excellence

, a blog series featuring contributions from members of the ophthalmic community. These blogs are an opportunity for ophthalmic bloggers to engage with readers with about a topic that is top of mind, whether it is practice management, experiences with patients, the industry, medicine in general, or healthcare reform. The series continues with this blog by 

It started out like a regular day. I had a busy morning of clinic patients, and as I sat across my 9:00 a.m. patient in the exam room, I asked my usual history and review of pertinent ophthalmic symptoms. He noted everything was great and his vision was very stable. As I scooted towards him with my chair to the slit lamp microscope, I noticed he still had his glasses on.

I kindly requested that he remove his glasses for the exam. He took them off, looked around a bit while waving them around, and finally placed them very inconveniently in front of my slit lamp joystick. If I had started to use the microscope, it would have crushed his glasses.

He also realized that it was not an appropriate place for the glasses and then decided to quickly take them and put them on the side table. Unfortunately, in his haste, the glasses missed the table and fell to the floor.

We both looked at each other and he said, “Well, where should I put my glasses safely?”

That’s when it hit me: There should be a place that patients can place their eyeglasses safely and securely during the slit lamp microscope examination. That’s when the spark of inspiration occurred! I still had a busy clinic of patients, so I continued working but could not shake off that inspiration euphoria.

As I continued seeing more patients, I noted very similar scenarios like the earlier patient interaction. They put their glasses on the side of the slit lamp, in front of it, dropped them or even smashed them in their pocket. 

and are reading this, you have probably encountered this problem on a daily basis in your practice.

As I returned home, inspiration evolved into a true idea: design an eyeglass holder that could attach to the table of the slit lamp microscope (or frankly, any table). I sat at my desk and sketched out the first prototype.

From this, I went to my local hardware store to gather the raw materials and dusted off my tool set to produce the first prototype of the Mali Eyeglass Holder. After ensuring its utility and function in clinic, I then patented the idea.

The next step in the journey-and the most daunting-was developing the manufactur-ing process. There were a few principles that I wanted to uphold during this process: it had to be manufactured here in the USA, and I wanted to make sure it would be affordable for the mass public. After considerable efforts, I located a manufacturing facility just ten miles from my home with the highest quality standards.

While my family, friends, and patients thought it was a great idea, I wanted to see if I could achieve further validation from the eyecare community at large prior to releasing the product for mass distribution and retail sales.

That’s when I saw an advertisement for The Winning Pitch competition at the ASRS 2018 Annual Meeting, a “Shark Tank” for eyecare ideas. At this competition, I won Honorable Mention, which gave me the additional motivation to proceed in bringing my invention to the eyecare market.

Now that I had a viable product, the final portion of my journey was setting up an official company, Mali Enterprises. From this, I developed my e-commerce website and now sell the product online direct to consumers. In addition, I am exploring potential licensing opportunities and international distribution strategies. What started out as inspiration in clinic one day has now become a true industry with retail sales and a patented product.

Throughout the whole journey, my greatest inspiration, motivation, and support has been my lovely wife Yasmin and my amazing daughter Julia. Yasmin helped me through every step of the process, from design to development. With their love and support, I obtain my greatest strength, which is the confidence that I can achieve anything.

The other pillar of strength in my life is my religion, The BahÃ¡'Ã­ Faith. It gives me a sense of purpose, a beacon of light to follow, and a strong foundation in my life. As an entrepreneur, one will face all types of challenges and it is how you respond to these and overcome them that will determine success.

One quotation that really helped me was: “Men who suffer not, attain no perfection. The plant most pruned by the gardeners is that one which, when the summer comes, will have the most beautiful blossoms and the most abundant fruit.”

This has truly been an amazing and educational journey: taking an idea, making an invention, obtaining a patent, developing a manufacturing process, executing a marketing strategy, and building a company and brand that I am truly proud of is the American Dream.

My advice to anyone reading this is if you have a product idea, no matter how simple or elaborate, just go for it. You never know where it will lead you, sky’s the limit. Make sure to keep a laser-like focus and stay true to your values, thus allowing you to achieve your goals and be a successful entrepreneur.


	E: malienterprisesglobal@gmail.com
	Dr. Mali is a board-certified ophthalmologist and award-winning vitreoretinal surgeon at The Eye Associates, a private multispecialty ophthalmology practice in Sarasota, FL. Dr. Mali’s relevant financial disclosures include founder & CEO of 

. You can view his product demonstration 

1. Author: Abdu'l-BahÃ¡. Paris Talks. BahÃ¡'Ã­ Reference Library. http://reference.bahai.org/en/t/ab/PT/pt-14.html. https://www.bahai.us/

If you have a product idea, no matter how simple or elaborate, just go for it! You never know where it will lead you, says Joshua Mali, MD. 

Ophthalmologist's idea sparks invention

Joshua Mali, MD, shares how breakthroughs in the technologic and therapeutic spaces will give way to a prosperous, data-rich 2019

,” a blog series featuring contribu-tions from members of the ophthalmic community. These blogs are an opportunity for ophthalmic bloggers to engage with readers with about a topic that is top of mind, whether it is practice management, experiences with patients, the industry, medicine in general, or healthcare reform. The series continues with this blog by

,  a vitreoretinal surgeon at The Eye Associates, a private multispecialty ophthalmology practice in Sarasota, FL. The views expressed in these blogs are those of their respective contributors and do not represent the views of 

Another year, another wave of technologic and therapeutic advancements. Check out Dr. Mali’s top five predictions for 2019, below:

1) 2019 will be the most data rich year in the history of ophthalmology

, big data from the IRIS registry, and post-marketing analysis from the most diverse spectrum of pharmaceuticals and medical devices in the market, 2019 will provide the most data ever to analyze across the entire dynamic field of ophthalmology. We will likely gain significant insight into scientific data and discoveries, clinical efficacy of newer ophthalmic pharmaceuticals, and overall current trends among ophthalmologists.

2) Home-based OCT will revolutionize the way we monitor wet AMD patients

 (ForeseeHome, Notal Vision) for patients with dry age-related macular degeneration (AMD), the device the cre-ates a new platform for monitoring wet AMD patients with its pioneering patient-operated home optical coherence tomography (OCT) system. It is designed to identify intraretinal and/or subretinal fluid in the central 10° of eyes diagnosed with wet AMD.

It will allow patients to complete the test at home while the machine-learning algorithm (Notal OCT Analyzer) performs an automated analysis which generates a report and transmits the information to a physician. This innovation represents the symbiotic rela-tionship between artificial intelligence (AI) and telemedicine that could revolutionize the way we monitor and determine treatment intervals for patients receiving intravitreal anti-VEGF injections.

While likely bringing it to market in 2020, we should have an update in 2019 with final product schematics and diagnostic capabilities. While the home-monitoring device is the flagship AI technological device in ophthalmology today for monitoring dry AMD, the home OCT system will inevitably be the new standard of care in wet AMD management.

3) Brolucizumab will receive FDA approval in 2019 and will be a blockbuster medication for wet AMD

Impressive clinical data from landmark clinical trials HAWK and HARRIER will make for an easy and rapid approval process. With its potential for 12-week dosing intervals and superior retinal anatomical benefits, brolucizumab 6 mg (Novartis) will definitely be a game-changer in the wet AMD market.

4) Mergers & acquisitions in the ophthalmic industry will take a temporary breather

After a frenzy of mergers & acquisitions in the ophthalmic industry in 2018, I believe there will be somewhat of a slowdown in consolidation efforts as companies focus more on internal infrastructure and optimization of product delivery. However, I expect expansion should revamp once again late 2020 and into 2021. 

5) There will be a much-needed pullback in government regulations in healthcare


	     
	While 2018 saw some significant healthcare regulations such as allowing Medicare Advantage plans to use step therapy for Part B drugs, I believe that President Trump and congress will likely ease regulations this year in an effort to ultimately benefit patients and physicians.

Unity is the key to overcoming any challenge or obstacle. It has been said that we "are the fruits of one tree, and the leaves of one branch".

 When we Americans are united as one people, we can solve any issue; thus, I am extremely optimistic that we will eventually achieve complete healthcare reform in the near future.

I look forward to keeping you updated throughout 2019 and beyond!


	E: jmali@theeyeassociates.com
	P: 941-923-2020 
	

Dr. Mali is a board-certified ophthalmologist and award-winning vitreoretinal surgeon at The Eye Associates, a private multispecialty ophthalmology practice in Sarasota, Flori-da. Dr. Mali’s relevant financial disclosures include the following: Regeneron (consult-ant, speaker, stock shareholder, research funding), Genentech/Roche (consultant, speaker), Notal Vision Inc. (consultant, speaker), Alimera Sciences (consultant, speaker, stock shareholder), Allergan (consultant, research funding), Sun Pharmaceutical Indus-tries Inc. (consultant, speaker), Medical Director of Macular Degeneration Association (consultant, speaker), and Founder & CEO of Mali Enterprises. Check out his website 

1. Author: BahÃ¡’u’llÃ¡h. BahÃ¡'Ã­ Reference Library. Gleanings From the Writings of BahÃ¡’u’llÃ¡h. Pages 287-289. http://reference.bahai.org

How do your predictions stack up to Dr. Mali’s? Check out below 

Joshua Mali, MD

Articles

Macular Degeneration Association unveils AMD Centers of Excellence

Ophthalmologist's idea sparks invention

Dr. Mali’s top 5 predictions in ophthalmology for 2019

Home-use AMD device increases efficacy of chair time, patient monitoring