More than 50% of patients state that the current eye shields using tape are uncomfortable and cumbersome. These problems may lower patient adherence and affect surgical outcomes. Postoperative eye shields can be uncomfortable, difficult to remove/replace for patients at home, and may inhibit airflow to the eye. Despite its status as an essential postoperative safety eye product and being used by every ocular surgeon in every single ocular surgery on the planet, the eye shield has been neglected and taken for granted to date. ![]() SNAPS Eye Shield will be the gold standard for postoperative ocular protectionĪs surprising as it may seem to any ophthalmologist reading this article, the simple postoperative eye shield has not seen (pardon the pun) any significant innovation for decades. Therefore, count on the FDA approval of pegcetacoplan in 2023.ģ. These 2 agents will usher in a new era in the treatment of GA, giving hope and optimism to patients who desperately need it. However, not too far behind is Iveric bio and its C5 inhibitor avacincaptad pegol (Zimura), which appears to be very promising as well and, I predict, will build upon previously released data from 2022. I believe the additional long-term data provide even more robust support for the product profile and I strongly believe the data will support eventual FDA approval in 2023. The FDA considered that to be a major amendment to the application, which means the target action 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. Although the retina community was hoping for the final FDA decision to be rendered by November 2022, Apellis submitted additional 24-month efficacy data to supplement its new drug application. ![]() Apellis’ FDA-submitted targeted C3 therapy, pegcetacoplan (Empaveli), has been designed to regulate excessive activation of the complement cascade, which can lead to the onset and progression of many serious diseases including GA. Although currently there are no FDA-approved treatments for GA/dry AMD, that will change in 2023. ![]() Geographic atrophy (GA) has been the final frontier in retina medicine. We will have an FDA-approved treatment for geographic atrophy For this reason, faricimab takes my top spot.Ģ. Genentech has 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 for many years to come. Since the recent permanent J-code release in October 2022, I suspect that we will see a significant acceleration in faricimab usage in the retina community for 2023. I have used it in all patient types (treatment-naïve and refractory patients, and stable patients wanting a longer duration from their current injection frequency) and have had tremendous success. I can tell you from real-world clinical experience (I have been using it in my patients since the FDA approval early in 2022) that faricimab is hands down the most potent anti-VEGF therapy on the market today. ![]() Its unique mechanism of action of simultaneously binding and 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). Not since the FDA approval of the first anti-VEGF agent, ranibizumab (Lucentis, Genentech), in 2006 have we had such an impressive innovation in neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) management, with the recent FDA approval of faricimab-svoa (Vabysmo), the first bispecific antibody designed for intraocular use. Vabysmo will take the lion’s share of the anti-VEGF market for nAMD and DME It’s that exciting time of the year again when I reveal my top 5 predictions in ophthalmology for 2023!ġ.
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