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.
Related: Focusing the battle against dry AMD
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.
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-brol....
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-associatio....
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....
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-ophtha....