It’s that exciting time of the year again when I reveal my top 5 predictions in ophthalmology for 2023!
1) Vabysmo will take the lion’s share of the anti-VEGF market for nAMD and DME
Not since the FDA approval from the first anti-VEGF agent, ranibizumab (Lucentis, Genentech), in 2006 have we had such an impressive innovation inside neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) management, with the recent FDA approval associated with faricimab-svoa (Vabysmo), the 1st bispecific antibody designed for intraocular use. Its unique mechanism of action of simultaneously binding plus neutralizing Ang-2 and VEGF-A has been demonstrated to be a very effective treatment for nAMD and DME, with robust visual gains, significant retinal optical coherence tomography (OCT) anatomical benefits, and the potential of extended durability (16-week dosing). I can tell you from real-world clinical experience (I have been using it in my patients since the particular FDA authorization early inside 2022) that faricimab is hands down the most potent anti-VEGF therapy on the particular market today. I have used it in all patient types (treatment-naïve and refractory patients, and stable individuals wanting a longer duration from their current injection frequency) plus have had tremendous success. Since the recent permanent J-code release in October 2022, We suspect that we will see a significant acceleration in faricimab usage within the retina community with regard to 2023. Genentech has already been an incredibly dynamic company that continues to produce unique innovations such as faricimab that will likely be game changers in the retina therapeutic space not only for 2023, but regarding many years to come. For this reason, faricimab takes my best spot.
2) We will have an FDA-approved therapy for geographic atrophy
Geographic atrophy (GA) has been the final frontier in retina medicine. Although currently there are no FDA-approved treatments intended for GA/dry AMD, which will change in 2023. Apellis’ FDA-submitted targeted C3 therapy, pegcetacoplan (Empaveli), offers been designed to regulate excessive activation of the complement cascade, which can lead to the particular onset and progression of many serious diseases including GA. Although the retina community was hoping for the final FDA decision to be rendered by November 2022, Apellis submitted additional 24-month efficacy data in order to supplement its new drug application. The FDA considered that to be the major amendment to the application, which means the target actions date will be pushed back 3 months to give the agency time to review the supplemental data, with an expected action date in February 2023. I believe the extra long-term data provide even more strong support for the product profile and I actually strongly believe the data will support eventual FDA acceptance in 2023. However , not too far behind is Iveric bio plus its C5 inhibitor avacincaptad pegol (Zimura), which appears to be very promising as well and, I predict, will certainly build upon previously released data through 2022. These 2 agents will usher in a new era in the treatment of GA, giving hope and optimism in order to patients who desperately need it. Therefore, count on the FOOD AND DRUG ADMINISTRATION approval associated with pegcetacoplan inside 2023.
SNAPS Eye shield
3) PHOTOS Eye Shield will be the gold standard to get postoperative ocular protection
As surprising as it may seem to any ophthalmologist reading this article, the simple postoperative eye safeguard has not seen (pardon the particular pun) any significant innovation for decades. Despite its status as an essential postoperative safety eye product and being used by every ocular surgeon in each single ocular surgery on the planet, the eye shield continues to be neglected and taken for granted to date. Postoperative eye shields can be uncomfortable, difficult to remove/replace for sufferers at home, plus may inhibit airflow towards the eye. These types of problems may lower patient adherence and affect surgical outcomes.
More than 50% of patients state that the current eye protects using tape are unpleasant and cumbersome. Complaints range from tape discomfort, reduced eye ventilation, and inconvenience while removing and replacing the cover for postoperative drop placement. Our extensive technological advances with premium IOLs, microinvasive glaucoma surgery, and retinal instrumentation possess far outpaced our focus on simple essential advances in one of our most important plus most frequently used surgical products…until now.
BUTTON SNAPS Eye Shield is a new high quality postsurgical eye shield that will can end up being easily placed, or removed, and requires no tape (see accompanying photo). The particular clear acrylic shield is very comfortable to wear, highly stable on the face, provides excellent airflow, and allows easy access pertaining to examination or drops. It was an honor for me to be a part of the team to help design plus develop this dynamic and innovative eye shield. My hope will be that we will be able in order to get this vision shield into every operating room plus on every single postoperative ocular surgery individual in the world to provide patients using the safest and most comfortable option on the particular market. SNAPS is a good FDA-cleared device and will be the gold standard in postoperative ocular protection starting within 2023. Learn more at www.snapseyeshield.com .
4) Biosimilars may struggle to advance in the ophthalmic therapeutic marketplace
Certainly, biosimilars have received some significant press in 2022. With the FDA approval of ranibizumab-nuna (Byooviz) in late 2021 and ranibizumab-eqrn (Cimerli) in August 2022, it would seem that 2023 would become a prime year meant for biosimilar advancement in the particular anti-VEGF market place. Nevertheless , in order to be honest and frank, it is not clear to me where biosimilars truly fit in within the ophthalmology/retina field. They obviously do not provide additional efficacy, durability, or security compared along with their tried and true branded counterparts, so other than a potential cost difference benefit, it appears to me personally that the uptake by clinicians will be poor.
On the other hand, We do sense that certain payers might eventually prefer that attention care professionals try a less costly biosimilar first in a step-edit fashion and have got to demonstrate failure prior to using a branded anti-VEGF real estate agent. This is the only scenario I could see as plausible, but this could take substantial time for you to actually be implemented (well beyond 2023) and will likely receive resistance from physicians and/or patients. If any associated with the biosimilar manufacturers are usually reading this particular and disagree with my prediction or even would like to discuss, feel free to contact me. Until then, the prediction upon biosimilars remains.
5) Retina analytic tools will be the new emerging industry
With OCT technology and retinal imaging becoming a vital part of the practice of retina, just because important is usually analysis of these data to help us make clinical decisions. Additionally, with all the advent associated with therapies designed for GA on the horizon, the need to monitor the growth of GA lesions plus display prediction models is definitely becoming paramount. Therefore, In my opinion that retina imaging analytic tools and software would be the new emerging industry blossoming in 2023.
One example of those types of technologies was announced recently by RetinAI Medical AG with the launch of Discovery CORE with artificial intelligence (AI), for retinal fluid plus layer segmentation. Discovery PRIMARY and the AI models have been designed to accelerate data analysis and assist clinical and academic researchers collaborate more efficiently in real time with their peers upon medical plus imaging information sets. The software measures retinal fluid volumes and layer thickness across OCT data sets automatically in real time. Further, this integrates annotation tools plus electronic case report forms, which enable new data insights to become collected across peer networks, keeping the information digitized, centralized, and secure. The functionality of CORE can be used to assess disease end points in scale; jump-start the building associated with registries and real-world evidence data units; and help with shared workflows to evaluate data, train physicians, plus establish best practices within the clinic. 2
With technologies like this and others within the pipeline, retinal specialists will have standardized evaluation tools just for conditions like nAMD, GA, retinal vein occlusion, plus DME that will refine our own current retinal disease management paradigm. This new business will have momentum inside 2023 and rounds out our top 5 forecasts.
2023 can be shaping up to end up being an amazing year. I actually look forward to keeping you updated throughout the year plus beyond.
Joshua Mali, MD
E: [email protected] com
Dr Mali is certainly 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 and CEO of Mali Enterprises ( www.malienterprises.org ). His financial disclosures include Genentech/Roche (consultant, speaker), SNAPS (equity owner), and RetinAI (consultant, research grant).
- Mali J. Doctor Mali’s top 5 predictions in ophthalmology for 2022. Ophthalmology Times ®. December 27, 2021. Accessed December 20, 2022. https://www.ophthalmologytimes.com/view/dr-mali-s-top-5-predictions-in-ophthalmology-for-2022
- Hutton D. RetinAI launches Discovery CORE AI-powered, collaborative platform to accelerate medical and academic research, plus RWE analysis in ophthalmology. Modern Retina . December 1, 2022. https:// ww. modernretina. com/view/retinai-launches-discovery-core-ai-powered-collaborative-platform-to-accelerate-clinical-and-academic-research-and-rwe-analysis-in-ophthalmology