- Roche on Monday reported positive late-stage data for its experimental eye drug faricimab, announcing that study results showed the biologic therapy was equal to Regeneron's Eylea in treating patients with diabetic eye disease.
- If approved, faricimab could replace Roche's venerable drug Lucentis, which was launched in 2006 but has faced tough competition from Eylea based on dosing frequency. Lucentis has since lost patent protection, and a cheaper biosimilar from Samsung Bioepis and Biogen is now under Food and Drug Administration review.
- The market for biologic treatments for eye diseases could be further upended in the U.S. in 2023, when Eylea is also set to lose its market exclusivity and face lower-cost biosimilars, too. The looming competition could influence how Roche plans to price faricimab, should it win approval.
The market for biologic therapies that treat diabetic macular edema and age-related macular degeneration has shifted not from the entry of more effective medicines, but rather by drugmakers proving more sustained benefit for existing ones.
When launched in 2006, Lucentis was dosed once every four weeks, a regimen that stretched ophthalmologists' ability to offer appointments to every patient with either eye condition.
Eylea extended the dosing interval out to eight weeks when Regeneron launched the drug in 2011. Now both companies have treatment protocols that can extend the period between eye injections to once every 12 weeks in age-related macular degeneration, or AMD.
In addition to Lucentis and Eylea, a weakened version of Roche's cancer drug Avastin is often used off-label to treat eye conditions.
Faricimab acts on two proteins that accelerate the growth of blood vessels in the eye and contribute to eye disease — one of them is VEGF, which Lucentis and Eylea target.
Roche designed two diabetic macular edema trials, which enrolled a total of nearly 2,000 patients, to test faricimab against Eylea at eight week dosing intervals. But the Swiss drugmaker included a third group of patients receiving faricimab on a "personalized" dosing interval of up to 16 weeks and tested eye acuity after one year of treatment.
While detailed data aren't available yet, Roche said the personalized doses "demonstrated non-inferior visual acuity gains compared to [Eylea] given every eight weeks." Treatment with faricimab was well-tolerated, the company added, with no new safety signals reported.
Roche plans to present full study data in February at a medical symposium called Angiogenesis, Exudation, and Degeneration 2021.
Roche sought early on to target diabetic macular edema, a more prevalent condition than the form of AMD that Lucentis and Eylea treat. Neither Lucentis nor Eylea is approved for a 12-week dosing protocol in macular edema.
Roche also has two trials ongoing in AMD. Both Eylea and Lucentis have 12-week dosing protocols approved in AMD, although the labels for both specify that it's not as effective as more frequent dosing intervals.
If faricimab is approved by regulators, Roche will need to set a price that passes muster with insurers. The less frequent dosing, which can reduce the strain on ophthalmologists' offices as well as potential side effects, could offer a better value, but insurers will likely be balancing that against the anticipated entry of less-expensive Lucentis and Eylea biosimilars.
Roche does, however, has some history with disruptive pricing of new products. In 2017, for example, the Swiss pharma launched its multiple sclerosis drug Ocrevus at a 20% discount to competitors.