AAO 2023: Dr. Caroline Baumal discusses the pegcetacoplan GALE extension study; offers leadership insights

Caroline Baumal, Chief Medical Officer at Apellis, spoke with Modern Retina about the pegcetacoplan GALE extension study for geographic atrophy. She also shared insights regarding her career transition, underscoring the significance of mentorship and a passion for one's work during this year's American Academy of Ophthalmology meeting in San Francisco.

Video Transcript

Editor's note - This transcript has been lightly edited for clarity.

Caroline Baumal, MD: I'm Caroline Baumal, [MD], chief medical officer at Apellis. The American Academy of Ophthalmology is a really exciting time for Apellis. Last year, we released our Phase 3 pivotal data from the OAKS [and] DERBY studies that eventually led to approval of SYFOVRE [pegcetacoplan injection] in early 2023 as the first FDA-approved agent to treat geographic atrophy [GA].

This year, for the first time, we will be releasing data from our GALE study. This is a 3-year extension study that follows OAKS and DERBY, and we'll be releasing data from the first year of GALE. This represents 3 years of continuous SYFOVRE treatment for some patients.

Some of the key highlights of this data are continued reduction in growth of GA lesions in both subfoveal and nonsubfoveal eyes. As well, we continue to see increasing effects over time and eyes with nonsubfoveal lesions show just over 40% reduction in GA lesion growth. One of the most interesting points is that eyes that were treated with sham for 2 years, then crossed over to SYFOVRE treatments...and in these eyes, there was a 19% reduction in GA lesion growth in the first year of GALE.

Also, we'll be presenting some really interesting microperimetry data, which highlights a visual function assessment showing reduced time to absolute scotoma in the central 4 and central 16 points in eyes treated with SYFOVRE. So, overall, this is an exciting time for Apellis to continue to produce this robust research based on our Phase 3 pivotal trials demonstrating the effect of SYFOVRE on patients with GA.

I'm coming up on my 1-year anniversary as Chief Medical Officer at Apellis. And this follows a long career at New England Eye Center in Boston doing retinal surgery and pediatric retina. I will say that it's been an amazing journey. I have learned so much in this time. I think as a retina surgeon and for most of my colleagues, we like to be continually challenged. And this is one of the amazing things about going from clinical positions into industry. The amazing amount of work that goes into having a drug approved and looking at new developments, and looking at the scientific data is continually keeping me engaged. And I think that I'm in a really unique position to have this understanding and show it to my colleagues and how we can use this clinically.

When colleagues asked me about what it's like to be a chief medical officer, I really encourage them to understand what it's like to work with industry and to, of course, always stay objective when we look at these and make decisions based on what's best for our patients.

I'm always asked by other retinal specialists and other women in retina if I have any advice about getting involved with industry or what factors played a role in my change in career. And there are two things that I'd really like to highlight.

One is I think it's really important to have mentorship. When I started doing retina, there were many less women in the field. And I'm so positively encouraged when I look out and I see the diversity of people at Subspecialty Day and at all of the retina meetings. So I think it's important to have a mentor, someone that you can learn from, even if it's someone who tells you about the hard choices and things you maybe don't want to hear about. It's really important. Even in my stage of the career, I mentor other people, but sometimes the students I teach actually teach me more than I'm teaching them.

The other thing I think is important, and this was something that was really key for me, was to be passionate and believe in what you're doing. The number one concern is to treat people with this debilitating retinal disease, geographic atrophy. So that really keeps me renewed every day. So, for me, it was very important to believe in what I do to make the decisions that I make.

I think as being a leader, it's always important to look back and consider the decisions that made you take the road that you take and to continually be able to modify yourself and be flexible with new scenarios.