Joshua Mali, MD, is a vitreoretinal surgeon at The Eye Associates, a private multispecialty ophthalmology practice in Sarasota, Florida.

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,” 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.

Articles

Financial takeovers rattle up the pharmaceutical world

 Ophthalmology grabs Wall Street’s attention  

, 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 

, 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 

Ophthalmology Times® or MJH Life Sciences.

Watch Dr. Mali's interview on what ophthalmologists should expect from the new year.

It is that exciting time of the year when I once again reveal my top 5 predictions in ophthalmology for 2021.



1. While COVID-19 will continue to dominate the headlines in 2021, the human spirit and innovation will ultimately achieve victory and prevail.

will likely continue to be the dominant story well into 2021. This virus has impacted every part of our society. 

However, I strongly believe in humanity’s ability to defeat this challenge through our unity in spirit and incredible ingenuity in innovation. It has been amazing to see the speed, efficiency, and potency of the worldwide efforts in clinical research and the pharmaceutical industry to fight and crush this virus. It is really an industry-wide team effort, with companies both big and small joining the battle. 

For example, as of this writing, pharmaceutical giant Pfizer distributing its 

vaccine with a massive distribution plan unseen in our country’s history. While possibly equally as impressive, small biotech company — Sorrento Therapeutics — has rapidly developed a tremendous pipeline of promising COVID-19 antibody treatments, vaccine candidates, and diagnostic tests that could hold the key to next generational management and a potential cure for this disease. 

Our unity as a society with unshakeable will and determination is what will win the battle against 

, and this takes the top spot in my predictions for 2021.




2. The competition battle lines will be drawn in 2021 for ocular therapeutics in the most common eye disease markets

 did impact the vast majority of our society, surprisingly. clinical research in ophthalmology did not stop. In fact, it continues to grow at a record pace with incredible amounts of data to analyze and interpret for clinical application in ophthalmology. 

With that as a backdrop, 2021 will see product launches and regulatory approvals for ocular treatments in all the major disease states in ophthalmology: dry eye, glaucoma, cataract/intraocular lens implants, and macular degeneration. 

We have never seen such innovation in multiple common ocular disease states simultaneously until now. 

A few potentially impactful players in 2021 to keep your eye on are Genentech and Kala Pharmaceuticals. Genentech delivers significant optimism with two exciting products: its Port Delivery System with ranibizumab (PDS) for exudative age-related macular degeneration (AMD) to provide a revolutionary sustained drug delivery system; and faricimab, the first bispecific antibody designed for intraocular use that can simultaneously bind and neutralize Ang-2 and VEGF-A, which appears to be a very effective treatment for wet AMD and diabetic macular edema (DME). 

Both these products will likely be game-changers in the retina therapeutic space. Kala’s recently FDA-approved EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25%, for the short-term treatment of the signs and symptoms of dry eye disease, will certainly be a major player in the dry eye market in 2021.

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

3. Artificial intelligence will continue its rise and application in clinical ophthalmology

I have been writing about artificial intelligence (AI) and its great potential for years — and rightfully so. This technology is designed to improve efficiency and data analysis, which has been strategically and successfully implemented into ophthalmology and, frankly, all of medicine. 

One particular device to keep your eye on is Notal Vision’s Home Optical Coherence Tomography (OCT) System. A new platform for monitoring wet AMD patients with its pioneering patient-operated design, it is utilized 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 relationship between AI and telemedicine that could revolutionize the way we monitor and determine treatment intervals for patients receiving intravitreal anti-VEGF injections. The Home OCT system will inevitably be the new standard of care in wet AMD management.

4. Telemedicine platforms will still play a role in ophthalmology

Telemedicine visits and utilization spiked in 2020 due to 

 practice restrictions and temporary shutdowns. However, it really was only an acceleration of an early trend that has been gaining traction over the past several years. 

While telemedicine will never replace a physical exam (especially in ophthalmology), I believe that telemedicine can be a helpful adjunct and service that ophthalmology practices can provide to benefit patients and patients will expect to have it available as an option in certain circumstances going forward.

5. Virtual ophthalmology conference options will be present for the majority of 2021

The adaptability of ophthalmology conferences and professional organizations in 2020 has been incredible. 

I have been so impressed by organizations such as the 

 American Society of Retina Specialists (ASRS)

, which put together successful and informative virtual annual meetings in such a short amount of time has been nothing short of amazing. 

The strong leadership of these organizations should be applauded for their ability to adapt and pivot during this challenging time to deliver stellar meetings. 

Due to this success, my prediction is that the major meetings in ophthalmology in 2021 and beyond will continue to have a virtual option to allow flexibility and more widespread participation for future meetings. 

In addition, meetings that take place during the end of 2021 will likely have a hybrid model: a live in-person meeting (with limited number of registered participants) and a simultaneous virtual meeting platform for those unable to attend the live event. 

The constant exchange and flow of ideas and knowledge is the lifeblood of our profession and will continue to thrive successfully.

With 2020 behind us, 2021 is shaping up to be an amazing year. I look forward to keeping you updated throughout 2021 and beyond.


is a board-certified ophthalmologist and award-winning vitreoretinal surgeon at The Eye Associates, a private multispecialty ophthalmology practice in Sarasota, Florida. He is also the founder & CEO of Mali Enterprises.He can be reached at malienterprisesglobal@gmail.com. Dr. Mali’s relevant financial disclosures include Genentech/Roche (consultant, speaker), Notal Vision Inc. (consultant, speaker), Sorrento Therapeutics (Nasdaq:SRNE) equity stock shareholder, Kala Pharmaceuticals (consultant, speaker).

1. Mali, Joshua. Dr. Mali’s Top 5 Predictions in Ophthalmology for 2019. 

In light of an unprecedented year filled with technological advancements and pivots, Joshua Mali, MD, offers his top 5 predictions in ophthalmology for 2021.

Dr. Mali's top 5 predictions for ophthalmology in 2021


Read Dr. Mali's article on what to expect in the new year. 

Videos

Joshua Mali, MD, speaks on his annual top 5 predictions in ophthalmology for what's to come in 2021.

Dr. Mali: Top 5 predictions for ophthalmology in 2021

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.