Phase III efficacy
In the Phase III clinical trials, the FAc implant was shown to be efficacious in the treatment of DMO, with benefits lasting for up to 36 months.6 The implant has a long-term microdose delivery system, which shows it has the potential to reduce the burden of managing the condition on the patient and health service, while improving visual outcomes.3,7
All patients included, however, had prior laser therapy and very few had received anti-VEGF therapies, whereas in real-world clinical practice the FAc implant is usually not considered until previous anti-VEGF treatments have failed to deliver a sufficient response. It was unclear, therefore, how it would perform outside of a clinical trial in real-world practice.
Using an electronic medical record data system (Medisoft), data has now been collected on real-world clinical treatment of chronic DMO for up to 24 months after patients have received a single FAc implant. These data, collected from 14 UK centres, show that 18.1% of treated eyes had 6/12 vision at baseline, rising to 39.6% at 24 months.3 86.7% of patients maintained or gained vision 24 months after receiving the implant, and 15% of patients achieved a ≥15 letter improvement at 12 months, which increased to 20.8% at 24 months.3
These efficacy findings confirm that the FAc implant is a useful treatment option for chronic DMO, even in patients who had a long duration of DMO and had received numerous prior DMO therapies. Additionally, they show a favourable safety profile with a similar frequency of intraocular pressure-related emergent adverse events to the Phase III trials.3
The key difference with the FAc implant over other DMO treatment options is the duration of action. In the Phase III trials, the FAc implant was shown to deliver visual benefits for up to 3 years, and current results show clinical practice achieves similar outcomes for up to 24 months.7 The Medisoft audit will continue to run in order to demonstrate whether results continue to be consistent with the clinical trials up to 36 months.
This real-world data has helped to build the evidence to show the sustained benefits of switching to the FAc implant in pseudophakic eyes that are insufficiently responsive to other therapies. The long duration of action of the product can also help to reduce the burden of treatments on the patient and health service.