Annexon Bolsters Ophthalmology Expertise with Appointment of Retina Specialist Lloyd Clark, M.D., as Pivotal ANX007 Program Advances in Dry Age-Related Macular Degeneration (AMD) with Geographic Atrophy (GA)
- Appointment of highly experienced Dr. Lloyd Clark with 25 years as retina specialist and involvement in 70+ clinical trials
- ANX007 is the only investigational therapy showing significant vision preservation in GA patients
- Phase 3 ARCHER II trial progressing with clear timeline for enrollment completion (Q3 2025) and topline data (H2 2026)
- Large market opportunity with 8 million patients worldwide and no approved therapies for vision preservation in GA
- Phase 3 trial results not expected until second half of 2026
- No approved therapies yet, indicating potential regulatory challenges in this space
Dr. Clark Brings 25 Years of Experience Treating Retina Diseases and Developing Emerging Therapies as a Principal Investigator in Over 70 Clinical Trials and as an Early Pioneer of VEGF Inhibitors
ANX007 is the Only Investigational Program Shown to Significantly Preserve Vision and Central Retinal Photoreceptors Critical for Visual Acuity
Enrollment of Phase 3 ARCHER II Trial Expected to be Completed in Q3 2025, with Topline Data Expected in Second Half of 2026
BRISBANE, Calif., June 18, 2025 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye, today announced the appointment of Lloyd Clark, M.D., as senior vice president, ophthalmology strategy and innovation. Dr. Clark brings more than 25 years of experience as a practicing retina specialist with deep expertise in drug development, portfolio strategy and bringing novel therapies to market.
Dry AMD with GA is a leading cause of blindness that affects more than eight million patients worldwide with no approved therapies targeting the preservation of vision. ANX007 is a non-pegylated antigen-binding fragment (Fab) designed to block C1q locally in the eye. ANX007 is the only investigational therapy in GA to show significant vision preservation on the endpoints of best corrected visual acuity (BCVA) and low luminance visual acuity (LLVA), as well as significant preservation of central retinal photoreceptors necessary for visual acuity. In the ongoing global, pivotal Phase 3 ARCHER II trial, ANX007 is being evaluated in patients who have dry AMD with GA, with enrollment expected to be completed in the third quarter of 2025 and topline data expected in the second half of 2026.
“Annexon’s approach to stopping inflammation at the start has shown clinically meaningful functional benefit for patients across neuroinflammatory diseases and now has the potential to change the GA treatment landscape in Europe and the U.S.,” said Douglas Love, president and chief executive officer of Annexon. “We are delighted to welcome Lloyd, an established ophthalmology pioneer with decades of experience navigating global clinical landscapes, who will play a key role in the strategic planning, development, and execution of our first-in-kind ophthalmology program. His addition to the Annexon team highlights the growing support of the retina community for a better treatment that preserves vision for dry AMD patients with GA and our unique opportunity to address the significant unmet need.”
Dr. Clark added, “I am thrilled to join the outstanding team at Annexon at this important time for the company as we complete enrollment in our ARCHER II program, putting us on a path towards pivotal Phase 3 data and global registration. ANX007 has shown the potential to preserve vision in patients with dry AMD, which to date has not been seen with any other therapy. I am excited to work with my colleagues, investigators, and the retina community to bring this therapy to patients.”
Lloyd Clark, M.D., joins Annexon with demonstrated success in treating patients and advancing new therapies for diseases of the eye. As a well-recognized and respected retina specialist, he brings 25 years of experience treating patients with GA, wet AMD and other retina diseases in the largest retina practice in the United States. For over the past decade, he also held a position as assistant clinical professor of ophthalmology at the University of South Carolina School of Medicine. Dr. Clark brings deep drug and clinical development experience, including serving as principal investigator in 70 clinical trials, and contributing to over 40 peer-reviewed publications as an early pioneer in the development of VEGF inhibitors. He earned his B.S. from Duke University and his M.D. from the University of North Carolina at Chapel Hill. Dr. Clark completed his residency at the Bascom Palmer Eye Institute, and subspecialty training in Vitreoretinal Diseases and Surgery at the Cleveland Clinic Foundation. He is an active member of The Retina Society and has received service awards from both the American Academy of Ophthalmology and the American Society of Retina Specialists.
About Dry AMD and Geographic Atrophy
Dry age-related macular degeneration (AMD) is the most common form of AMD and geographic atrophy (GA) is an advanced form of dry AMD, an eye disease that is a leading cause of blindness in the elderly. Dry AMD and GA are chronic progressive neurodegenerative disorders of the retina involving the loss of photoreceptor synapses and cells in the outer retina. GA affects an estimated one million people in the United States and eight million people globally, severely limiting their independence and causing frustration, anxiety and emotional hardship. Effective treatments that preserve vision are still needed, as no currently approved therapies have been shown in clinical trials to significantly prevent vision loss.
About Phase 3 ARCHER II Trial
ARCHER II is a global, randomized, double-masked, sham-controlled Phase 3 trial expected to enroll approximately 630 patients with geographic atrophy (GA) secondary to age-related macular degeneration who will be randomized 2:1 to receive a monthly dose of ANX007 or sham procedure. The primary endpoint is the prevention of ≥15-letter loss of best corrected visual acuity (BCVA), which represents three lines on the standard Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart. The primary analysis will occur between 12 and 18 months from dosing initiation based on the accumulation of target events (patients in the overall study experiencing BCVA ≥15-letter loss on consecutive visits). Proportion of patients experiencing BCVA ≥15-letter loss is a well-established functional endpoint that has served as the basis for numerous ophthalmology drug approvals by the U.S. FDA and European Medicines Agency (EMA). Secondary endpoints in ARCHER II include safety, low-luminance visual acuity (LLVA), and photoreceptor integrity (EZ). Topline data are expected in the second half of 2026.
About Annexon
Annexon Biosciences (Nasdaq: ANNX) is developing therapeutics that stop classical complement-driven neuroinflammation as first-in-kind treatments for millions of people living with serious neuroinflammatory diseases of the body, brain and eye. Our novel scientific approach focuses on C1q, the initiating molecule of classical complement’s potent inflammatory pathway that when misdirected can lead to tissue damage and loss. By targeting C1q, our immunotherapies are designed to stop this neuroinflammatory cascade in disease before it starts. Our pipeline spans three diverse therapeutic areas – autoimmune, neurodegenerative and ophthalmic diseases – and includes targeted investigational drug candidates designed to address the unmet needs of over 8 million people worldwide. Annexon’s mission is to deliver game-changing therapies to patients so that they can live their best lives. To learn more visit annexonbio.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements about: the potential therapeutic benefit of ANX007; timing and pace of completion of enrollment and topline data from the Phase 3 ARCHER II trial; ANX007’s distinct potential neuroprotective mechanism of action and potential to provide protection from vision loss; the potential benefits from treatment with anti-C1q therapy; and continuing advancement of the company’s portfolio. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the company’s history of net operating losses; the company’s ability to obtain necessary capital to fund its clinical programs; the early stages of clinical development of the company’s product candidates; the effects of public health crises on the company’s clinical programs and business operations; the company’s ability to obtain regulatory approval of and successfully commercialize its product candidates; any undesirable side effects or other properties of the company’s product candidates; the company’s reliance on third-party suppliers and manufacturers; the outcomes of any future collaboration agreements; and the company’s ability to adequately maintain intellectual property rights for its product candidates. These and other risks are described in greater detail under the section titled “Risk Factors” contained in the company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and the company’s other filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Contact:
Joyce Allaire
LifeSci Advisors
jallaire@lifesciadvisors.com
Media Contact:
Julia Stern
Real Chemistry
763-350-5223
jstern@realchemistry.com
FAQ
Who is Dr. Lloyd Clark and why is his appointment significant for Annexon (ANNX)?
What makes Annexon's ANX007 unique in treating Geographic Atrophy (GA)?
When will Annexon (ANNX) complete enrollment for the ARCHER II trial and release results?
What is the market potential for Annexon's (ANNX) GA treatment?
What is ANX007 and how does it work in treating Geographic Atrophy?
