Dr. Josh Mali, Retina, Uncategorized

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).