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REVIEW

CURRENT
OPINION Geographic atrophy: current and future therapeutic
agents and practical considerations for
retinal specialists
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Priya Vakharia a and David Eichenbaum a,b

Purpose of review
Geographic atrophy (GA) from age-related macular degeneration (AMD) remains a leading cause of vision
loss. The purpose of this review is to summarize currently available intravitreal therapeutics, and discuss
pipeline therapeutics that are currently in clinical trials.
Recent findings
The FDA approval of pegcetacoplan and avacincaptad pegol, both approved in 2023, represent the first
therapeutics to treat GA. These are delivered via intravitreal injections, and have been shown to slow
progression of GA. Both drugs have a risk of new onset neovascular age-related macular degeneration
(nAMD). Initial indications seem to be that pegcetacoplan therapy has higher risks of inflammation,
vasculitis, and nonarteritic ischemic optic neuropathy (NAION) as compared to avacincaptad pegol, but
more real-world data will help to clarify this further. Pipeline therapeutics that we discuss include intravitreal
gene therapy, oral anticomplement therapy, and intravitreal injections of a novel glycoprotein.
Summary
Both pegcetacoplan and avacincaptad pegol are FDA approved to treat GA. The decision to treat patients
is still complex and nuanced, but the approval of two treatments for GA is a tremendous advance in our
field. Future therapeutics may further refine our ability to treat patients more effectively and safely.
Keywords
avacincaptad pegol, dry age-related macular degeneration, geographic atrophy, pegcetacoplan, pipeline
therapeutics

INTRODUCTION inflammation and loss of complement regulation

Geographic atrophy (GA) is a variant of dry age-
related macular degeneration (AMD) and is a major
visual issue amongst the elderly population in the
United States and globally. It is characterized by the
progressive loss of the retinal pigment epithelium
(RPE), photoreceptors, and the choriocapillaris,
leading to significantly impaired visual function
[1]. Many factors influence GA development,
including age, smoking, genetics, and diet [2,3].
Certain genetic factors can also predispose to GA,
including the Complement Factor H, Complement
Factor C3, and ARMS2/HTRA1 genes [3,4].
It remains unclear which dry AMD patients will
develop GA, but we know that oxidative stress and
complement overactivity play a role in those who do
develop GA [4,5]. When the RPE is exposed to
oxidative stress, extracellular drusen can develop
[4,5]. Excessive drusen formation then triggers sec-
ondary inflammation through multiple pathways,
especially the complement cascade [4,5]. This
is believed to be a key driver for the subsequent RPE,
photoreceptor, and choriocapillaris damage that
leads to GA [4,5].
CLINICAL MANIFESTATION/
PROGRESSION
Patients with GA often arrive to the clinic with a
multitude of presentations. The classic presentation
is of the late stage patient with foveal involvement,
who presents with dense central scotomata and a
a
Retina Vitreous Associates of Florida, St. Petersburg and bMorsani
College of Medicine, University of South Florida, Tampa, Florida, USA
Correspondence to Priya Vakharia, MD, 4344 Central Avenue, St.
Petersburg, FL 33711, USA. Tel: +1 727 323 0077;
e-mail: pvakharia@rvaf.com
Curr Opin Ophthalmol 2024, 35:000–000
DOI:10.1097/ICU.0000000000001046

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Retinal, vitreous and macular disorders
KEY POINTS
 Treatment of geographic atrophy (GA) with
pegcetacoplan showed a reduced GA lesion growth of
35% in the monthly arm and 24% in the every-other-
month arm at 3 years in the GALE study.
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 Treatment of GA with avacincaptad pegol showed a
reduced GA lesion growth rate of 14% with monthly
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injections and 19% with every other month injections at
2 years in the GATHER2 study.
 There is a 2--4% risk of inflammation and a 1/10 000
risk of retinal vasculitis or occlusive retinal vasculitis
with pegcetacoplan therapy to date.
 There has been only one reported case of inflammation
with avacincaptad pegol to date, with no cases of
occlusive or nonocclusive retinal vasculitis to date.
 Pipeline therapeutics include oral danicopan,
intravitreal gene therapy with JNJ-81201887, and a
novel glycoprotein for intravitreal treatment AVD-104.
significant and historically progressive decline in
best-corrected visual acuity (BCVA) causing visual
impairment [6,7]. However, prior to this later stage
of center-involving GA, patients can experience
symptoms from parafoveal scotomas, which can
present with good central visual acuity but with
patient complaints of difficulty seeing, reading, or
FIGURE 1. Fundus autofluorescence (a) shows hypoautofluorescence corresponding to areas of geographic atrophy, with
perilesional hyperautofluorescence suggestive of areas of dysfunctional RPE. The corresponding atrophy can be seen on near
infrared imaging (b) as areas of hyporeflectivity. This patient has foveal-threatening GA. GA, geographic atrophy; RPE, retinal
pigment epithelium.
2 www.co-ophthalmology.com
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doing daily tasks [8]. Intervention at this earlier
stage prior to foveal involvement is critical to help
prevent visual acuity decline from GA.
Modalities used in the clinic to monitor GA
progression include spectral-domain or swept-
source optical coherence tomography (OCT), near-
infrared imaging (NIR), fundus photography (FP),
and fundus autofluorescence (FAF) (Figs. 1 and 2)
[9]. The average rate of GA progression ranges from
0.53 to 2.6 mm2/year (median around 1.78 mm2)
[1,10,11]. Certain factors increase the likelihood of
progression, including multifocality, extrafoveal
location of GA, and banded/trickling patterns on
FAF [1,12,13].
CURRENT FDA-APPROVED THERAPIES
Current therapies focus on the complement cas-
cade, targeting different factors in the complement
cascade to help mitigate inflammatory damage that
leads to progressive GA.
In 2023, the first anticomplement therapies
were FDA-approved for the treatment of GA. The
first drug approved was pegcetacoplan, also known
&&
as Syfovre (Apellis, Waltham, MA) [14 ]. Pegceta-
coplan was approved in the February 17, 2023 as an
intravitreal anticomplement injection targeting C3,
a factor thought to be central in the complement
cascade. Pegcetacoplan is approved for monthly or
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FIGURE 2. Spectral-domain OCT imaging of a patient with foveal-threatening GA. Near-infrared imaging (a) shows foveal-
threatening GA. The scan is segmented at the location of the green line, with corresponding cross-sectional B-scan (b) showing
full thickness central GA with choroidal hypertransmission (white arrow). GA, geographic atrophy; OCT, optical coherence
tomography.

every other month (EOM) intravitreal dosing via
intravitreal injection, and has shown reductions
in the rate of GA lesion growth at 2 years of 19%
in the monthly arm and 16% in the EOM arm in
DERBY, or 22% in the monthly arm and 18% in the
&&
EOM arm in OAKS [14 ]. The GALE extension study
showed even higher numbers at 3 years, with
reduced GA lesion growth of 35% in the monthly
arm and 24% in the EOM arm compared to pro-
jected sham. There were increased treatment effects
noted with cumulative dosing (13% monthly/14%
EOM from months 0 to 6 compared to 39% monthly/
32% EOM arm from months 24–30) [15,16]. Even
higher numbers were noted in the nonsubfoveal
lesion group, with 45% in the monthly arm
and 33% in the EOM arm from months 24 to 30
[15,16].
Treatment with pegcetacoplan is not without
risks. As with all intravitreal injections, there is a risk
of endophthalmitis. Intraocular inflammation was
reported at a rate of 2–4%, ischemic optic neuro-
pathy at a rate of 0.2–1.7%, and new-onset neo-
vascular AMD at a rate of 7–12% (as compared to 3%
&&
new-onset nAMD in the sham arms) [14 ]. There
have also been postmarketing reports of occlusive
and nonocclusive retinal vasculitis, at a rate of about
1 in 10 000 injections, all seen after the first injec-
&&
tion of pegcetacoplan [17 ].
On August 4, 2023, the second therapy for the
treatment of GA was approved. Avacincaptad pegol,
also known as Izervay (Iveric Bio/Astellas, Cranbury,
NJ), is an anticomplement injection targeting C5,
further downstream on the complement cascade
&&
than C3 [18 ]. It is approved for monthly dosing
in concordance with the effects seen at that dosing
rate at the 1-year primary endpoint. There is a
potential label update to every-other-month dosing
possible based on the 2 year results, since patients
were re-randomized to monthly or EOM dosing at
the end of year 1, and the results maintained with
both dosing strategies through year 2. In the
GATHER2 trial at year 2, patients had a 14% reduc-
tion in the mean rate of GA growth with monthly
injections and 19% with EOM injections [19,20].
Similar to pegcetacoplan, the treatment effect seems
to increase with continued use, with the treatment
effect (mean rate of GA growth from baseline) more
than doubling over 2 years as compared to the treat-
ment effect over 1 year [19,20].
Treatment with avacincaptad pegol has risks
similar to pegcetacoplan, including a risk of
endophthalmitis as with all intravitreal injections
and a risk of neovascular AMD at a rate of 11.6%
compared to 9% sham. There was only one reported
case of nonserious intraocular inflammation in the
GATHER2 trial [19,20], so the risk of inflammation
with avancicaptad pegol may be less than with
pegcetacoplan. There is less real-world data to date
with avancicaptad pegol since it has not been com-
mercially available for as long.

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Retinal, vitreous and macular disorders
THERAPIES IN THE PIPELINES
There are many therapeutics in the pipelines for GA,
ranging from oral medications to gene therapy.
Herein, we will focus on three specific GA studies,
but we certainly recognize that many more are in
development and may represent treatment options
in the future.
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The first potential therapeutic is danicopan, an
oral complement factor D inhibitor, sponsored by
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Alexion Pharmaceuticals (Boston, MA) [21]. Danico-
pan is approved in Japan for paroxysmal nocturnal
hemoglobinuria [22]. This is a phase 2, double-
masked, placebo-controlled, dose range finding
study of danicopan (ALXN2040) in patients with
GA secondary to AMD. Enrollment is complete, with
around 365 participants enrolled. The primary out-
come measure being studied is change from baseline
to week 52 in the square root of the total GA lesion
area in the study eye, as measured by FAF. Patients
enrolled have nonfoveal GA without any history of
wet macular degeneration in their study eye. Patients
in this study receive either Danicopan 100 mg b.i.d.,
200 mg b.i.d., 400 mg b.i.d., or placebo. At 52 weeks, if
the optimal dose is determined, patients will be
switched to the optimal dose for the remainder of
the study through week 104 [21]. An oral therapeutic
would be welcome in the vitreoretinal community as
a way to treat this disease without the heavy treat-
ment burden that come with intravitreal injections.
The second potential therapeutic that we would
like to highlight is intravitreal gene therapy JNJ-
81201887, sponsored by Janssen pharmaceuticals
(Beerse, Belgium) [23]. This trial is recruiting as
of Spring 2024, and is a phase 2b, randomized,
double-masked, multicenter, dose-ranging, sham-
controlled clinical trial to evaluate intravitreal
JNJ-81201887 (AAVCAGsCD59) compared to sham
for treating GA secondary to AMD. Patients eligible
to enroll in this trial are nonfoveal involving GA
patients, with the goal of around 300 patients to be
included in the study. The investigational product,
JNJ81201887, is a gene therapy that codes for an
anti-CD59 protein. CD59 is the final component of
the complement cascade, and inhibiting CD59
activity may reduce the formation of membrane
attack complex and subsequent cell death. Patients
are randomized to receive either JNJ81201887 low
dose, high dose, or sham. The primary endpoint is
change from baseline in square root of GA lesions
area in the study eye at month 18, measured by FAF
[23]. Gene therapy remains promising in the GA
landscape due to the ability to deliver a therapeutic
agent with a single treatment.
The third therapeutic that we would like to touch
on is a novel glycoprotein delivered via intravitreal
injection [24,25]. The SIGLEC trial is a multiple dose
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study of AVD-104 for GA secondary to AMD, spon-
sored by Aviceda (Cambridge, MA) [24,25]. This
trial is looking at AVD-104, which is an intravitreal
glycan-coated nanoparticle that directly inhibits
macrophages and inhibits complement cascade
amplification. Clinical trials with this agent have also
suggested antineovascular activity. 300 participants
are currently being enrolled as of Spring 2024 into
part 2 of this phase 2 study, which is a double-masked,
randomized, multicenter study looking at high dose
every-other-month AVD-104, monthly low dose
AVD-104, and active comparator (monthly avacin-
captad pegol). The primary endpoint is the difference
in the rate of growth of the GA area as measured by
FAF [24,25]. While this remains an intravitreal ther-
apy, it is possible that the ability of this particle
to modulate the inflammatory activity of immune
cells could serve an unmet need to in retina, and
this mechanism of action may perform differently
than pure complement activity modulation with
pegcetacoplan or avacnicaptad pegol.
PRACTICAL CONSIDERATIONS IN
REGARDS TO TREATMENT
The decision to treat a patient is complex and
nuanced. Current FDA-approved therapies such as
pegcetacoplan and avacincaptad pegol only slow
progression of disease, but do not stop progression
and do not reverse any prior changes. Furthermore,
at 2 years, both drugs failed to show any visual acuity
or function benefit in prespecified endpoints in
patients who were treated with anticomplement
therapies compared to sham, although there are
posthoc analyses for both drugs suggesting some
visual benefit, either based on microperimetry
[26] or numbers of letters lost [20]. As with all
clinical trials, therapies that are currently in devel-
opment could succeed or could fail, and only time
will tell if any of these potential therapeutic options
have functional benefits from our patients.
That being said, without any treatment, the
natural history of the disease is that patients with
GA will progress relentlessly and experience visual
loss. These patients often remain optimistic and
hopeful that current and future therapeutics will
help their visual acuity.
Currently, the ideal patient to treat is likely one
that has not yet experienced vision loss from foveal
GA, who is motivated and wishes to do everything
possible to avoid GA progression. However, even
foveal-involved GA patients with some preserved
visual function can have treatment, and it is reason-
able to have a discussion regarding treatment
options with all patients who have GA, focusing
on certain key points.
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Geographic atrophy: current and future therapeutic agents and practical considerations for retinal specialists Vakharia and Eichenbaum
First, patients need to understand that these
drugs are not stopping progression or reversing pro-
gression, but are slowing progression. Second, the
risks of therapies need to be stressed, specifically the
risks of endophthalmitis, wet AMD, inflammation,
vasculitis, and NAION as discussed previously.
Third, it is important to stress the importance of
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compliance with therapies and a commitment to
treatment, as these drugs do require continued
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injections to get treatment effect.
CONCLUSION
The approval of pegcetacoplan and avacincaptad
pegol marks the first time that we have therapeutics
available to treat an otherwise blinding condition.
Even considering their limitations, the approval of
two treatments for GA is a tremendous advance in
our field. Perhaps we will even begin to treat before
full-thickness GA is noted, and start treating at ear-
lier signs of incomplete retinal and RPE atrophy if
we can identify patients at the highest risk for
advancement [27]. It will be an exciting time to
see how the therapeutic options change over time,
and to see if any of our medications in development
have promising results.
Acknowledgements
None.
Financial support and sponsorship
None.
Conflicts of interest
P.S.V. and D.A.E. are consultants, speakers, and inves-
tigators for Iveric Bio and Apellis. P.S.V. and D.A.E. are
investigators for Aviceda, Janssen, and Alexion. DAE has
equity interests in Janssen.
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READING
Papers of particular interest, published within the annual period of review, have
been highlighted as:
& of special interest
&& of outstanding interest
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