Joshua Mali, MD

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It’s that time of the year again when I reflect on an exciting and dynamic year in ophthalmology! Here are my top 5 most significant stories in ophthalmology for 2019:

Dr. Mali's top 5 stories in ophthalmology for 2018

FDA approves brolucizumab for treatment of wet AMD

As of this writing, it has been more than eight years since a new anti-VEGF has been approved, and it could not have come at a better time. As the prevalence of exudative age-related macular degeneration (wet AMD) continues to climb worldwide, 

with a new FDA-approved blockbuster medication to combat wet AMD: brolucizumab (Beovu).

The approval was based on the phase III results of the HAWK and HARRIER trials. The drug met its primary endpoint of non-inferiority versus aflibercept in best-corrected visual acuity (BCVA) and exhibited superiority in key retinal outcomes at year one (48 weeks).
	Secondary endpoints at year two (96 weeks) reaffirmed superiority of brolucizumab in reduction of retinal fluid, an important marker of disease activity in wet AMD.

Additionally, of the patients on brolucizumab who successfully completed year one on a 12-week dosing interval, 82% in HAWK and 75% in HARRIER were maintained on a 12-week dosing interval in year two.

Study targets potential treatment for nAMD

In late June, AbbVie announced its plan to acquire Allergan for $63 billion in one of the 

largest purchases the financial world has seen this year

While AbbVie already had its foot in the door with its blockbuster drug adalimumab’s

(Humira) indication for non-infectious uveitis, the Allergan acquisition takes its stature to an elite level in ophthalmology. With Allergan’s staple of bread-and-butter products like onabotulinumtoxinA (Botox), cyclosporine (Restasis), and dexamethasone (Ozurdex) providing a respectable cash flow, the true jewel of the deal lies within Allergan’s potentially lucrative pipeline.

In particular, two promising retina treatments: 

) for the treatment of geographic atrophy (dry AMD) and abicipar pegol for treating wet AMD. These new treatments for retinal conditions affecting millions of patients aim to lead in both clinical and financial success.

Macular Degeneration Association unveils AMD Centers of Excellence

Founded in 2007, the Macular Degeneration Association (MDA) is a nonprofit health organization dedicated to educating and empowering AMD patients through ophthalmic education, advocacy, and fundraising efforts. A new grassroots initiative for AMD patient care was unveiled earlier this year: AMD Centers of Excellence (COE).


	
	This program designates eyecare practices that evaluate and treat AMD patients across the United States as providing them with the highest standard of care. This distinction will help patients locate these outstanding facilities in their area.

In addition, being a member of the AMD COE gives practices’ patients access to patient education materials and services. This grassroots effort is supported by the leading AMD patient advocacy organization in the country, with credentials and criteria developed to serve the best interests of AMD patients.
	
	For more information, go to 

4. Alcon’s new trifocal IOL implant granted FDA approval

Alcon’s AcrySof IQ PanOptix Trifocal IOL, the first trifocal lens for U.S. patients undergoing cataract surgery, 

.
	
	The device has been clinically shown to deliver an exceptional combination of near, intermediate, and distance vision while significantly reducing the need for glasses after surgery.


	
	As IOL technology continues to evolve and reach new heights, ophthalmologists are able to achieve advanced clinical results and increasingly deliver patient satisfaction outcomes.
	
	

Striving for perfection: Creating the perfect IOL

5). Healthcare law reform maintains status quo


	While there seemed to be some momentum earlier this year regarding potential positive reforms to existing healthcare regulations, these have taken a backseat to other legislative priorities and political issues.
	
	However, 

notable changes affecting ophthalmologists

 have included Medicare Advantage plans utilizing step therapy for Part B drugs and additional cuts by CMS for procedures like cataract surgery.

Ultimately, it will take the efforts of all Americans to solve the healthcare policy issue.

I also have some ideas on how to develop the nation’s healthcare policy for all sides-patients, physicians, hospitals, pharmaceutical companies, insurance companies, and the government.

There must be stabilization in the U.S. healthcare system to allow physicians/ophthalmologists to continue to provide the best healthcare delivery for patients.   

This has been a tremendous year in the history of ophthalmology and it provides momentum to the coveted year of the eye: 2020. I look forward to keeping you updated throughout 2020 and beyond!
	
	

 is a board-certified ophthalmologist and award-winning vitreoretinal surgeon at The Eye Associates, a private multispecialty ophthalmology practice in Sarasota, FL.


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

Dr. Mali’s relevant financial disclosures include the following: AbbVie (stock equity owner); Allergan (consultant/advisory board/investigator/research funding); Macular Degeneration Association (medical director/consultant/speaker); Novartis (consult-ant/speaker), and founder and CEO of Mali Enterprises.

1.  Novartis. Two-year data for Novartis brolucizumab reaffirm superiority versus afliber-cept in reducing retinal fluid in patients with nAMD. Available at:  https://www.novartis.com/news/media-releases/two-year-data-novartis-brolucizumab-reaffirm-superiority-versus-aflibercept-reducing-retinal-fluid-patients-namd.
	2. Mali J. Ophthalmology grabs Wall Street’s attention. 

. Available at: https://www.ophthalmologytimes.com/Blogs/WallStreet.
	3. Mali J. Macular Degeneration Association unveils AMD Centers of Excellence. 

. Available at: https://www.ophthalmologytimes.com/blogs/macular-degeneration-association-unveils-amd-centers-excellence.
	4. Alcon. Alcon introduces AcrySof IQ PanOptix TriFocal IOL in the US, the first and only FDA-approved trifocal lens. Available at: https://www.alcon.com/media-release/alcon-introduces-acrysof-iq-panoptix-trifocal-iol-us-first-and-only-fda-approved.
	5. Mali J. Dr. Mali’s Top 5 stories in Ophthalmology for 2018. 

. Avail-able at: https://www.ophthalmologytimes.com/article/dr-malis-top-5-stories-ophthalmology-2018.

Articles

Dr. Mali's top 5 stories in ophthalmology for 2019

,” 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 

AbbVie announced its plan to acquire Allergan plc for $63 billion

 in one of the largest purchases the financial world has seen to date. In doing so, AbbVie threw down the gauntlet and established itself as a new leader in the ophthalmology space. While the company already had its foot in the door with its blockbuster drug adalimumab (Humira, AbbVie) the Allergan acquisition raises the bar for its competitors.
	
	With Allergan bread-and-butter staples like 

cyclosporine ophthalmic emulsion 0.05% (Restasis)

dexamethasone intravitreal implant (Ozurdex)

 providing revenue, the true jewel of the deal lies within Allergan’s potentially lucrative pipeline.
	
	In particular, two promising retina treatments, a 

brimonidine drug delivery system (Brimo DDS

) for the treatment of geographic atrophy-dry age-related macular degeneration (AMD)-and abicipar pegol for treating wet AMD. These new treatments for retinal conditions affecting millions of people will lead to both clinical and financial success.
	
	Does the AbbVie deal represent the beginning of more acquisitions or was this just an uncommon event?
	
	When we look at some other recent transactions-

, for instance; Biogen’s takeover of Nightstar Therapeutics; and Roche acquiring Spark Therapeutics-certainly this appears to be a significant trend towards dynamic mergers and acquisitions in the ophthalmology space.
	
	Clearly, ophthalmology is getting Wall Street’s attention!    


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

Dr. Mali is an award-winning vitreoretinal surgeon at The Eye Associates, a private multispecialty ophthalmology practice in Sarasota, Florida. He is also the Founder & CEO of 

. His relevant financial disclosures include the following: Stock Equity Owner in AbbVie; Consultant & Investigator (research funding) with Allergan.

Financial takeovers rattle up the pharmaceutical world

 Ophthalmology grabs Wall Street’s attention  

It’s that time of the year again when I reflect on such an exciting and dynamic year in ophthalmology! Here are my top 5 most significant stories in ophthalmology for 2018:

1)  Innovations in the treatment of retinal diseases soars to new heights

As the prevalence of exudative age-related macular degeneration (wet AMD), retinal vein occlusion (RVO), and diabetic macular edema (DME) continues to climb worldwide, the ophthalmological industry has responded with amazing innovation in drug R&D, drug delivery systems, and new approved indications.

a)  Genentech continues to impress with several exciting treatments in the pipeline. Faricimab – the first bispecific antibody designed for the eye – dosed every four months demonstrated sustained vision outcomes compared to monthly ranibizumab for patients with wet AMD. In addition, further Phase II data for the Port Delivery System with ranibizumab (PDS), dosed every six months or longer, showed that visual acuity and anatomical outcomes in wet AMD are comparable to ranibizumab dosed every four weeks. Global Phase III studies in Genentech and Roche’s ophthalmology portfolio have commenced – two for faricimab in DME and one for the PDS in wet AMD. Overall, Genentech has focused on lowering the treatment burden in wet AMD, through novel mechanisms and long-acting delivery systems, and has the potential to address under-treatment and improve patient outcomes.

b) Regeneron’s Eylea demonstrated positive top-line results for the treatment of patients with moderately severe to severe non-proliferative diabetic retinopathy without diabetic macular edema (PANORAMA). Eylea continues to be a major force in the treatment of wet AMD, DME, and RVO. 

c) Novartis announced additional brolucizumab Phase III results from year two that reaffirmed its positive year one findings. Brolucizumab met its primary endpoint of non-inferiority versus aflibercept in best corrected visual acuity (BCVA) and exhibited superiority in key retinal outcomes at year one (48 weeks). Secondary endpoints at year two (96 weeks) reaffirmed superiority of brolucizumab 6 mg in reduction of retinal fluid, an important marker of disease activity in wet AMD. Additionally, of the patients on brolucizumab 6 mg who successfully completed year one on a 12-week dosing interval, 82% in HAWK and 75% in HARRIER were maintained on a 12-week dosing interval in year two. Brolucizumab will likely achieve FDA approval in 2019 and will be an exciting new option for the treatment of wet AMD.  

d) Allergan’s Abicipar Pegol met the pre-specified criteria and primary endpoint in both SEQUOIA and CEDAR clinical trials, signaling the possibility of fixed every 12 week dosing for patients with wet AMD. Likely seeking FDA approval in 2020, Abicipar Pegol will be the successful leading pioneer in a novel class of DARPin (Designed Ankyrin Repeat Proteins) molecules and may usher in a dynamic family of molecules to treat retinal vascular diseases with multiple targets.

e) Alimera Sciences reported significant increase in ILUVIEN utilization this year worldwide, demonstrating the excellent long-term efficacy and unique drug delivery mechanism with continuous microdosing of fluocinolone acetonide to treat DME. 

2) Artificial Intelligence (AI) has arrived and is here to stay

Described in one of my previous articles as one of the 5 greatest ophthalmic innovations of the 21st century, telemedicine represents a new frontier of our field focusing on two main principles: prevention and early disease detection.

While I believe artificial intelligence will never replace doctors, I do believe AI will have a significant role in medicine now and in the future. Leading the way, the ForeseeHome (FSH) technology created by Notal Vision is the flagship telemedicine AI technological device in ophthalmology today and has become the new standard of care in age-related macular degeneration (AMD) monitoring.

Notal recently announced that the FDA has granted breakthrough device designation for its pioneering patient-operated Home Optical Coherence Tomography (OCT) System. This device could revolutionize the way retinal specialists manage wet AMD.

In addition, IDx-DR is approved for use of autonomous detection of diabetic retinopathy in diabetic patients utilizing the Topcon NW400 fundus camera.

Finally, Tilak has created Odysight, a mobile application medical game dedicated to the monitoring of patients with chronic eye diseases. AI is being incorporated into the medical field and specifically ophthalmology at a rapid rate and is having a significant benefit to both patients and healthcare professionals.

3) American Board of Ophthalmology (ABO) delivers excellent updates to the Maintenance of Certification (MOC) process for Board Certification

Under the incredible leadership of Dr. George Bartley and his team, the ABO has developed impressive new initiatives to improve the board certification process and MOC. Here are just a few highlights of recent note:

a) No PIMS: The activities known as Practice Improvement Modules or “PIMs” will be removed from the ABO MOC requirement. Instead, starting in 2019, diplomates have a number of new ways to address this part of the MOC. The most notable change is the option to read designated Quality Improvement articles and answer questions through the article-based section of the Quarterly Questions program. Another new option is to choose an approved CME activity from a menu called the ACCME Program and Activity Reporting System (PARS). Diplomates can also choose to design an independent project, use IRIS Registry/their EHR data to develop a project, or participate in a collaborative project at their institution through the Multi-Specialty Portfolio Program. This new creative initiative provides more options to diplomates and allows for flexibility.

b) More Value from Quarterly Questions: The ABO is continuously adding to the value of the Quarterly Questions program. The program remained quite popular in 2018 – 9 out of 10 participants say they would recommend it to a colleague. The ABO will also make patient safety-themed articles and questions available to help diplomates satisfy the patient safety requirement of MOC. Of note, completing Quarterly Questions will also be worth 8 CME/Self-Assessment CME (SACME) credits in 2019. Quarterly Questions has allowed diplomates to experience both lifelong learning and ongoing clinical/professional assessment via participation in this exceptional and modern program.

c) No DOCK or PORTs: Demonstration of Ophthalmic Cognitive Knowledge (DOCK) and Periodic Ophthalmic Review Test (PORT) no longer exist in MOC. Since the Quarterly Questions program has fully replaced the DOCK (the last administration of the DOCK occurred on December 1, 2018), both the DOCK and PORTs will be removed from the MOC requirement in board certification.  

4) American Academy of Ophthalmology (AAO) unveils plans to build new Museum of Vision

Announced recently at the AAO 2018 Annual Meeting, the American Academy of Ophthalmology unveiled plans to construct the world’s first public museum dedicated to vision and eye health. The Museum of Vision will be located in San Francisco.

This free, public museum and education center will introduce the world to the science of sight and to the field of ophthalmology dedicated to protecting it. It will be the only publicly accessible, comprehensive collection of ophthalmic artifacts on permanent display in the United States.

The Academy is undertaking this effort to highlight the rich history of medical and surgical eye care and to help people understand their own eye health. The opening of a museum in San Francisco enables the Academy to showcase its collection of more than 38,000 artifacts, books, and instruments. These treasures have been collected for more than 30 years as the Museum of Vision, but opportunities to view them are limited to a yearly exhibit at the Academy’s annual conference.

Some of the collection can be also viewed by appointment at the Academy’s headquarters, located in San Francisco. The Academy hopes that bringing its extensive collection out in the open for the public to experience will help people understand their own eye health and what ophthalmologists do to protect their sight, inspiring the next generation of eye physicians and surgeons.

5) Healthcare law reform has started to take shape     

Rounding out my top 5 stories is a compilation of small changes to existing healthcare regulations.

While complete healthcare reform has taken a backseat to other legislative priorities, there have been some minor changes in healthcare in 2018. While it remains to be seen if complete repeal of the Affordable Care Act (ACA) or continued modifications/adjustments to existing healthcare law will be the path forward, President Trump and Congress continue to work diligently on a broad solution for healthcare reform.

There were some notable changes this year including repealing the ACA individual mandate and allowing Medicare Advantage plans to use step therapy for Part B drugs beginning January 1, 2019.

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 or any of our politicians from Congress 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 was definitely a year to remember in the history of ophthalmology and provides momentum to an exciting 2019. I look forward to keeping you updated throughout 2019 and beyond!

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 or jmali@theeyeassociates.com. 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), Alimera Sciences (consultant, speaker, stock shareholder), Allergan (consultant, research funding), Sun Pharmaceutical Industries Inc. (consultant, speaker), Medical Director of Macular Degeneration Association (consultant, speaker), and Founder & CEO of Mali Enterprises.

1. Mali, Joshua and Mali, Yasmin. What ophthalmologists are thankful for: The 5 greatest ophthalmic innovations of the 21st century. Ophthalmology Times. November 24, 2016.   
	http://ophthalmologytimes.modernmedicine.com/ophthalmologytimes/news/what-ophthalmologists-are-thankful
	2. Mali, Joshua. Dr. Mali's top 5 predictions in ophthalmology for 2017. Ophthalmology Times. December 24, 2016.
	http://ophthalmologytimes.modernmedicine.com/ophthalmologytimes/news/dr-malis-top-5-predictions-ophthalmology-2017?page=0,2
	3. https://eyewire.news/articles/aao-announces-4-million-gift-to-aid-construction-of-a-public-museum-dedicated-to-vision-and-eye-health
	4. McGowan, Meghan. American Board of Ophthalmology (ABO). Email correspondence. November 9, 2018.
	5. Genentech Press Release. New Stairway study data shows potential for extended durability with Faricimab in wet AMD. October 27, 2018.
	6. Novartis Press Release. https://www.novartis.com/news/media-releases/two-year-data-novartis-brolucizumab-reaffirm-superiority-versus-aflibercept-reducing-retinal-fluid-patients-namd

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 three of a three-part Clinical Innovations series discussing the results from case studies using an at-home monitoring system for patients with AMD. 

, is a vitreoretinal surgeon at The Eye Associates, a private multispecialty ophthalmology practice in Sarasota, FL.

As of 2014, more than 15 million Americans are estimated to have age-related macular degeneration (AMD).

 The percentage of patients who will progress from early or intermediate dry AMD to advanced stages of the disease over five years ranges from 0.5% to 45%, depending on a number of risk factors including drusen size and retinal pigment epithelium (RPE) changes.

On average, however, studies have shown that the median progression rate of dry AMD ranges from 1.49 mm

However, the ability to predict which patients will have a rapid rate of progression and which will be unlikely to progress significantly over time is highly challenging, if not impossible. In addition to the AREDS 5-year risk scale,

 other risk factors, such as family history and lifestyle, may make progression more likely although there is no definitive progression model.

This uncertainty understandably causes great anxiety for patients and doctors alike as we work diligently to detect the progression from dry AMD to wet AMD as soon as possible. With the home-use monitoring device (ForeseeHome device, Notal Vision), we finally have a viable option for consistent, accurate monitoring and early detection.


The device allows me to catch wet AMD early in the conversion process. Prior to utilizing it, I did not have many options for monitoring my patients with AMD. My patients were generally put on the AREDS2 vitamin formulation recommended in the Age-Related Eye Disease Study 2 (AREDS2) and instructed not to smoke, have a good diet, exercise regularly, and utilize sunglasses.

In addition, they were also given an Amsler grid to self-monitor for any vision changes. However, predicting which patients will truly progress to wet AMD, and when, is a challenge. While the Amsler grid has helped many patients since its development, its ability to detect change is inconsistent.

Additionally, by the time the patient notices a significant difference in his or her own visual acuity, severe and potentially irreversible damage might have already transpired. With the home-use device, patients and doctors do not need to rely solely on utilizing a lined piece of paper to prompt recognition of visual acuity changes.

Now, we have a more objective, reliable tool that can detect minute changes and directly alert the eye-care provider when there are significant changes in vision and retinal anatomy. Once an alert is issued, we can schedule an immediate follow-up appointment and perform an examination to confirm choroidal neovascularization (CNV).


Fortunately, of the more than 100 patients I currently have on the device, I have had only a few patients receive non-CNV alerts and only two patients who have had a CNV alert.
My first case involves a 75-year-old female with a history of exudative AMD in her left eye – treated with intravitreal aflibercept (Eylea, Regeneron) and intermediate dry AMD in her right eye. Her visual acuity was 20/30 OD at baseline. When the device alert was triggered, the patient was asymptomatic yet I still instructed her to come to the office as soon as possible for an evaluation.

Upon examination of the patient (Figure 1), she was still 20/30 OD and the OCT (Figure 2) had borderline findings, however, a small CNV membrane was confirmed on fluorescein angiography (Figure 3). Of note, the location of the CNV was just temporal to the optic disc and therefore not involving the central macula at this point.

Consequently, the patient was asymptomatic and the conversion to exudative AMD was confirmed solely with clinical examination and additional testing with OCT and fluorescein angiography. The aflibercept treatment was initiated and the patient is currently 20/25 OD.

The home-use device was critical in bringing this patient into my office for evaluation and allowed for prompt management. As this patient was already receiving treatment for wet AMD in her fellow eye, she knew the stakes were high and was happy for the early detection and saving her sight.

My other  CNV alert was from a 78-year-old female with a history of exudative AMD in her right eye–also being treated with intravitreal aflibercept–and intermediate dry AMD in her left eye. Her left eye baseline visual acuity was 20/40. Of note, this patient typically spends six months in Sarasota, FL and six months in Cincinnati, OH. When the home-use device alert occurred in her left eye, she was completely asymptomatic and was at that time still in Cincinnati.

After analyzing her report (Figure 4), I immediately arranged for her to be evaluated in Cincinnati in which her vision was still 20/40 OS but on dilated fundus exam there was the presence of subretinal fluid and subretinal hemorrhage noted in the macula OS. The patient received her first anti-VEGF (vascular endothelial growth factor) injection OS in Cincinnati and she then returned to Sarasota where I have continued her current treatment regimen. She currently has maintained her 20/40 vision OS due to prompt response to the FSH alert and early anti-VEGF treatment initiation.  

As with most diseases in medicine, earlier detection often results in a less-aggressive disease overall, less treatment needed in the long run, and a much better outcome where we can preserve and perhaps even improve vision. This device has great potential for patients who have dry AMD with vision that is 20/60 or better in the testing eye. Basically, any patient who is prescribed AREDS2 vitamins and meets the device’s eligibility criteria should be prescribed this device.

Patients do not need to be tech savvy as the device is easy to use. It also has a good training program designed to help anyone learn how to use it, whether it is learning how to use a computer mouse or connecting the device to Wi-Fi.

Additionally, there are very helpful educational aids in place to help patients understand the device and emphasize the importance of consistent/regular testing. The bottom line is, if the patient is in danger of developing wet AMD, he or she needs to be on the device to provide the highest level of patient care.

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: Notal Vision Inc. (consultant, speaker), Regeneron (consultant, speaker, stock shareholder, research funding).

Wong WL, Su X1, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health. 2014;2(2):e106-116.


Davis MD, Gangnon RE, Lee LY, et al. Age-Related Eye Disease Study Group. The Age-Related Eye Disease Study severity scale for age-related macular degeneration: AREDS Report No. 17. Arch Ophthalmol. 2005;123:1484-1498.


Lim PC, Layton CJ. Prognostic implications of imaging in atrophic macular degeneration and its use in clinical practice and clinical trial design. Clin Exp Ophthalmol. 2016;44:410-421.


Crossland M, Rubin G. The Amsler chart: absence of evidence is not evidence of absence. Br J Ophthalmol. 2007;91:391-393.

Author | Joshua Mali, MD

Articles

Dr. Mali's top 5 stories in ophthalmology for 2019

Ophthalmology grabs Wall Street’s attention

Dr. Mali's top 5 stories in ophthalmology for 2018

AMD home-monitoring device: case studies