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

Author(s):

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.

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:

1. 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, Novartis has responded 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.¹

2. AbbVie acquires Allergan

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.²

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: brimonidine drug delivery system (Brimo DDS) 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.

3. 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).³

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.

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, received FDA approval.

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.⁴

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

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.⁵

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!

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

Disclosures:

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.

References:

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. Ophthalmology Times. Available at: https://www.ophthalmologytimes.com/Blogs/WallStreet.
3. Mali J. Macular Degeneration Association unveils AMD Centers of Excellence. Ophthalmology Times. 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. Ophthalmology Times. Avail-able at: https://www.ophthalmologytimes.com/article/dr-malis-top-5-stories-ophthalmology-2018.