It’s that time of the year again when I reflect on such an exciting and dynamic year in ophthalmology! Here are my top 5 most significant stories in ophthalmology for 2018:
1) Innovations in the treatment of retinal diseases soars to new heights
As the prevalence of exudative age-related macular degeneration (wet AMD), retinal vein occlusion (RVO), and diabetic macular edema (DME) continues to climb worldwide, the ophthalmological industry has responded with amazing innovation in drug R&D, drug delivery systems, and new approved indications.
Here are the main highlights:
- a) Genentech continues to impress with several exciting treatments in the pipeline. Faricimab – the first bispecific antibody designed for the eye – dosed every four months demonstrated sustained vision outcomes compared to monthly ranibizumab for patients with wet AMD. In addition, further Phase II data for the Port Delivery System with ranibizumab (PDS), dosed every six months or longer, showed that visual acuity and anatomical outcomes in wet AMD are comparable to ranibizumab dosed every four weeks. Global Phase III studies in Genentech and Roche’s ophthalmology portfolio have commenced – two for faricimab in DME and one for the PDS in wet AMD. Overall, Genentech has focused on lowering the treatment burden in wet AMD, through novel mechanisms and long-acting delivery systems, and has the potential to address under-treatment and improve patient outcomes.
- b) Regeneron’s Eylea demonstrated positive top-line results for the treatment of patients with moderately severe to severe non-proliferative diabetic retinopathy without diabetic macular edema (PANORAMA). Eylea continues to be a major force in the treatment of wet AMD, DME, and RVO.
- c) Novartis announced additional brolucizumab Phase III results from year two that reaffirmed its positive year one findings. Brolucizumab 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 6 mg in reduction of retinal fluid, an important marker of disease activity in wet AMD. Additionally, of the patients on brolucizumab 6 mg 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. Brolucizumab will likely achieve FDA approval in 2019 and will be an exciting new option for the treatment of wet AMD.
- d) Allergan’s Abicipar Pegol met the pre-specified criteria and primary endpoint in both SEQUOIA and CEDAR clinical trials, signaling the possibility of fixed every 12 week dosing for patients with wet AMD. Likely seeking FDA approval in 2020, Abicipar Pegol will be the successful leading pioneer in a novel class of DARPin (Designed Ankyrin Repeat Proteins) molecules and may usher in a dynamic family of molecules to treat retinal vascular diseases with multiple targets.
- e) Alimera Sciences reported significant increase in ILUVIEN utilization this year worldwide, demonstrating the excellent long-term efficacy and unique drug delivery mechanism with continuous microdosing of fluocinolone acetonide to treat DME.
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 or [email protected]. 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), Alimera Sciences (consultant, speaker, stock shareholder), Allergan (consultant, research funding), Sun Pharmaceutical Industries Inc. (consultant, speaker), Medical Director of Macular Degeneration Association (consultant, speaker), and Founder & CEO of Mali Enterprises.
1. Mali, Joshua and Mali, Yasmin. What ophthalmologists are thankful for: The 5 greatest ophthalmic innovations of the 21st century. Ophthalmology Times. November 24, 2016.
2. Mali, Joshua. Dr. Mali's top 5 predictions in ophthalmology for 2017. Ophthalmology Times. December 24, 2016.
4. McGowan, Meghan. American Board of Ophthalmology (ABO). Email correspondence. November 9, 2018.
5. Genentech Press Release. New Stairway study data shows potential for extended durability with Faricimab in wet AMD. October 27, 2018.
6. Novartis Press Release. https://www.novartis.com/news/media-releases/two-year-data-novartis-brol...