Advantages of Brolucizumab in a Clinical Setting

The hallways of the 2019 American Society of Retina Specialists Annual Meeting were empty on Saturday morning around 11 a.m., as most attendees found themselves attending a session examining the 96-week data for brolucizumab from the HAWK and HARRIER trials.

While a Biologics License Application, which was submitted in April by Novartis, is still under review by the US Food and Drug Administration, that has not stopped conversations around how the potential novel treatment could change management of wet age-related macular degeneration (wAMD).

After his presentation, Carl Regillo, MD, director of retina service at Wills Eye Hospital and professor of ophthalmology at Thomas Jefferson University, sat down with MD Magazine® to discusss the findings of the HAWK and HARRIER trials. Regillo, who added he expects brolucizumab to be approved, also laid out his opinion on how approval of this potential novel therapy could impact care of patients with wAMD.

MD Mag: What potential advantages does brolucizumab offer over standard anti-VEGF treatments?

Regillo: It is highly likely to influence patient compliance in a favorable way. Right now, it's not that patients choose not to come back — that may happen but it's usually a delay. They may be scheduled 8 weeks out but it may turn into 9 or 10 weeks out. It could be a snowstorm, could be an illness that you were in the hospital. If that happens over and over and over then they're likely to lose the vision gains that we get early on. It's likely to compromise the long-term vision outcomes, but with something that's more durable you've got a little more latitude in terms of the treatment interval.

So, it's not only about extending it but it's also having that flexibility in terms of when they really do for the next treatment. See, in practice, we do a treat an extend approach with these anti-VEGF and we're going to continue to use the new drugs that are likely to be FDA approved soon in the same fashion.

Each patient has a different treatment interval based on their specific needs and in practice with our current therapeutics that range of treatment intervals is between 4 and 12 weeks and then we sort of arbitrarily cap it at 12 weeks but studies do show that not many people can go beyond 12 weeks about a third of patients can go 12 weeks with our current drugs. This has the potential to have a half the patients go 12 weeks.

So, you're shifting that distribution to sort of the mean and median is shifting towards something longer and the range and we might now be looking at 8 to 16 weeks or 8 to 14 weeks and that's meaningful — that's very meaningful for our patients. If you were getting injections 6 or 8 times a year and, if I told you, you can get 1 or 2 less treatments and 1 or 2 less visits great. That's meaningful for patients.