Roche recently announced the positive top line results of two global phase 3 studies of the same design, TENAYA (NCT03823287) and LUCERNE (NCT03823300). These two studies are evaluating the bispecific antibody faricimab in the treatment of patients with neovascular or "wet" age-related macular degeneration (nAMD). Each study has 2 treatment groups: faricimab 6.0mg (every 8 weeks, or 12 weeks, or 16 weeks once a fixed interval dosing regimen, according to the 20th and 24th week disease activity assessment), Eylea (aflibercept, Aflibercept) 2.0 mg interval dosing schedule every 8 weeks.
Both studies reached the primary endpoint and showed that the vision results obtained by patients who received faricimab injection every 16 weeks were not inferior to those who received Eylea injection every 8 weeks. In these two studies, nearly half (45%) of patients received faricimab injections every 16 weeks during the first year.
It is worth mentioning that this is the first time an injectable ophthalmic drug has reached this level of durability in a Phase 3 study conducted in nAMD patients. In 2 studies, faricimab was generally well tolerated, and no new or unexpected safety signals were found.
The results of TENAYA and LUCERNE are based on the positive results of Phase 3 studies of YOSEMITE and RHINE. The latter two are global Phase 3 studies with the same design. The positive top-line results were announced in December 2020. The data supports the potential of faricimab as a treatment option for diabetic macular edema (DME). The detailed results of these four studies will be announced at the 18th American Annual Conference on "Angiogenesis, Exudation, and Degeneration 2021" in February 2021, and will be submitted to the US FDA and Approved by global regulatory agencies including EU EMA.
Faricimab is the first bispecific antibody specifically designed for the eye, targeting two different pathways-through angiopoietin-2 (Ang-2) and vascular endothelial growth factor A (VEGF-A), these two pathways Can drive a variety of retinal diseases, including nAMD and DME. Ang-2 and VEGF-A destabilize blood vessels, cause new leaky blood vessels to form, and increase inflammation, which leads to decreased vision. By blocking these two pathways alone, faricimab aims to stabilize blood vessels, and for patients with retinal diseases, it has the potential to obtain better vision results in the long term.
Neovascular age-related macular degeneration (nAMD, also known as wet AMD, wet-AMD) affects approximately 20 million people worldwide and is the leading cause of blindness among people 60 years and older. The current standard of care, namely injections that inhibit vascular endothelial growth factor (VEGF), has significantly reduced the rate of vision loss caused by nAMD. However, VEGF is not the only way to participate in the occurrence and development of this complex disease. With anti-vascular endothelial growth factor monotherapy, nAMD patients must go to the ophthalmologist for monthly injections to help maintain improved vision and/or prevent vision loss. This high treatment burden may lead to inadequate treatment and may lead to suboptimal vision results. It has been more than 15 years since a drug with a new mechanism of action was approved for the treatment of nAMD.
Levi Garraway, MD, Roche's Chief Medical Officer and Head of Global Product Development, said: "These results show the potential of faricimab as a novel drug that can extend the treatment interval for patients with neovascular age-related macular degeneration (nAMD). We Now we have seen positive and consistent results in nAMD and diabetic macular edema (DME) in 4 phase III studies of faricimab. We look forward to submitting these data to global regulatory agencies so that this promising The treatment plan to the patient."
In the world, there are an estimated 21 million patients with DME, which is an estimated 21 million people worldwide suffering from dimethyl ether, which is the primary cause of vision loss among working-age adults. Although anti-vascular endothelial growth factor (VEGF) single-agent injections significantly reduce vision loss in DME patients, the treatment burden associated with frequent eye injections and doctor visits may lead to insufficient treatment and may lead to suboptimal vision results . It has been nearly a decade since a drug with a new mechanism of action was approved to treat DME.
In the 2 phase 3 studies (YOSEMITE, RHINE) announced in December 2020, each study has 3 treatment groups, and patients are randomly assigned to receive faricimab or Eylea at a fixed 8-week interval dosing regimen (dosing once every 8 weeks) ), or receive a 16-week personalized interval dosing regimen of faricimab (dosing once every 16 weeks).
The results showed that both studies reached the primary endpoints: faricimab was administered once every 8 weeks and the personalized dosing interval of up to 16 weeks, compared with Eylea once every 8 weeks, showed improved vision Non-inferiority. In terms of a secondary endpoint, in the two studies, more than half of the patients in the faricimab personalized administration group maintained a 16-week interval between treatments in the first year. It is worth mentioning that this is the first time an investigational drug has achieved this level of durability in a Phase 3 study conducted in DME patients. In 2 studies, faricimab was well tolerated and no new safety signals were found.