SYFOVRE offers longer preservation of sight in GA.

Nicole May is a retired nurse midwife from Boston who loves to read. She is also one of some 1 million people in the United States, and 8 million worldwide^1,2 suffering from geographic atrophy (GA), a disease that relentlessly steals the vision of patients with dry AMD.

There is no cure for GA, but ophthalmologists can now offer Ms. May and others like her the first treatment that demonstrates the ability to significantly slow progression of the disease. Apellis Pharmaceuticals in February began marketing SYFOVRE (pegcetacoplan injection), which received FDA approval for the treatment of GA, an advanced form of dry AMD.

THE ‘FIRST SUCCESSFUL COUNTEROFFENSIVE’

“It’s very exciting because there’s been nothing before [SYFOVRE],” says Ms. May, who was diagnosed with GA 3 years ago and is among the first to receive the therapy. “This is the first successful counteroffensive in the war.”

A progressive and irreversible disease, GA is caused by the growth of lesions that destroy the retinal cells responsible for vision. Overall, GA progression rates reported in the literature for total study populations range from 0.53 to 2.6 mm²/year (median, ~1.78 mm²/year).³

Ms. May’s excitement is justified, says Eleonora Lad, MD, PhD, director of ophthalmology clinical research and an associate professor of ophthalmology at Duke University Medical Center in Durham, N.C.

“This medication is a game changer in the field of dry AMD. It’s the beginning of a new therapeutic era, and it will help a lot of patients preserve their retinal tissue and vision for longer. We’re very excited to have it,” says Dr. Lad, who was the lead investigator on the OAKS trial, which was one of two Phase 3 trials that led to approval of SYFOVRE, with the other being the DERBY trial.

“It’s a complete paradigm shift. We’ve had no treatment options for GA up until the approval of SYFOVRE,” agrees Jordana G. Fein, MD, MS, partner physician at Retina Group of Washington, and an assistant professor of ophthalmology at Georgetown University School of Medicine. Dr. Fein also was a principal investigator in the OAKS and DERBY trials.

CLINICAL TRIAL RESULTS

Both multicenter, randomized, double-masked, sham-controlled studies compared SYFOVRE with sham injections across a representative population of patients with GA secondary to AMD. SYFOVRE targets complement component 3 (C3), which is a part of the body’s immune system.

Researchers evaluated the efficacy of monthly and every-other-month (EOM) SYFOVRE by assessing the change in total area of GA lesions from baseline as measured by fundus autofluorescence at 24 months. The two studies found that both regimens reduced GA lesion growth rates through 24 months compared to sham injections.

In the OAKS study of 637 dry AMD patients, the rate of GA progression was reduced by 22% with monthly injections and 18% with EOM injections. In the DERBY study of 621 patients, the rate of progression fell by 18% with monthly injections and 17% with EOM injections. SYFOVRE demonstrated a strong safety profile in ~12,000 injections, with the most common side effects (greater than 5%) being ocular discomfort, neovascular AMD, vitreous floaters and conjunctival hemorrhage. SYFOVRE is contraindicated in patients with ocular or periocular infections, and in patients with active intraocular inflammation.

“We’ve been using the drug commercially for a few months,” Dr. Fein says. “I had at least four or five eyes that I treated this morning with SYFOVRE in patients who are coming back for their 8-week follow-up and/or their first injection in the fellow eye.

My treated patients have done well so far, without complications related to the medication or the injection procedure. So [it’s] so far, so good on that front.”

BENEFIT GROWS OVER TIME

In the trials, SYFOVRE also demonstrated increasing treatment benefit over time, with the greatest benefit (up to 36% reduction in lesion growth with monthly treatment in the DERBY trial) occurring between months 18-24.

“The longer patients stay on the drug, the better the drug works in protecting the remaining retinal tissue and photoreceptors,” says Dr. Lad. “This is a chronic condition, and patients will need to stay on this treatment for life to protect them better and better over time.”

For Ms. May, who has already lived with AMD for more than 30 years, that’s a small price to pay for the potential to keep her ability to read and go about her daily activities for a longer period of time than she otherwise might.

“Even if I have only 10 more minutes I can read than I would have had, I’ll take it,” she says. OM

Disclosures: Dr. Lad is a consultant to Apellis Pharmaceuticals.
Dr. Fein is a member of the Apellis Speakers’ Bureau.

REFERENCES

1. Rudnicka AR, Jarrar Z, Wormald R, et al. Age and gender variations in age-related macular degeneration prevalence in populations of European ancestry: a meta analysis. Ophthalmology. 2012;119:571-580.
2. American Academy of Ophthalmology. Geographic atrophy. https://eyewiki.aao.org/Geographic_Atrophy . Accessed April 24, 2023.
3. Fleckenstein M, Mitchell P, Freund KB, et al. The progression of geographic atrophy secondary to age-related macular degeneration. Ophthalmology. 2018;125:369-390.