APLS Apellis Pharmaceuticals Inc

Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced today that the Therapeutic Goods Administration (TGA) has approved SYFOVRE® (pegcetacoplan) for the every-other-month treatment of adult patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) with an intact fovea and when central vision is threatened by GA lesion growth. SYFOVRE is the first and only approved treatment for GA in Australia.

"The approval of SYFOVRE marks a significant milestone for GA patients across Australia. For the first time, Australians with GA will have a treatment to slow the progression of this irreversible form of vision loss,” said Jeffrey Eisele, Ph.D., chief development officer, Apellis. “Building on the success in the U.S., we are excited to bring SYFOVRE to even more patients who are impacted by this devastating disease.”

More than 75,000 Australians are living with GA, an advanced form of AMD and leading cause of blindness worldwide.1 It is a progressive and irreversible disease caused by the growth of lesions, which destroy the retinal cells responsible for vision. The vision loss caused by GA severely impairs independence and quality of life.

“As a retina specialist, I have seen how GA often takes away a person’s ability to read, drive, and even see faces of their loved ones,” said Professor Robyn Guymer, AM, deputy director, Centre for Eye Research Australia. “The approval of SYFOVRE is a historic moment full of hope for the Australian GA community, who have been waiting for a treatment.”

The approval is based on results from the Phase 3 OAKS and DERBY studies at 24 months. In the studies, treatment with both every-other-month and monthly SYFOVRE slowed GA progression and showed a generally well-tolerated safety profile. The results were published in The Lancet in October 2023.

About SYFOVRE® (pegcetacoplan injection)SYFOVRE® (pegcetacoplan injection) is the first-ever approved therapy for geographic atrophy (GA). By targeting C3, SYFOVRE is designed to provide comprehensive control of the complement cascade, part of the body’s immune system. SYFOVRE is approved in the United States and Australia.  

About ApellisApellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first-ever therapy for geographic atrophy, a leading cause of blindness around the world. We believe we have only begun to unlock the potential of targeting C3 across many serious diseases. For more information, please visit http://apellis.com or follow us on X and LinkedIn.

Apellis Forward-Looking StatementStatements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors discussed in the “Risk Factors” section of Apellis’ Annual Report on Form 10-K with the Securities and Exchange Commission on February 27, 2024 and Quarterly Report on Form 10-Q filed on November 5, 2024 and the risks described in other filings that Apellis may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Apellis specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Media Contact: Lissa Pavluk media@apellis.com  617.977.6764

Investor Contact: Meredith Kaya meredith.kaya@apellis.com617.599.8178 

References

1. Keel S, Xie J, Foreman J, van Wijngaarden P, Taylor HR, Dirani M. Prevalence of Age-Related Macular Degeneration in Australia: The Australian National Eye Health Survey. JAMA Ophthalmol. Nov 1 2017;135(11):1242-1249. doi:10.1001/jamaophthalmol.2017.4182