REGENXBIO Announces Presentation at the American Academy of Ophthalmology 2025 Annual Meeting

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REGENXBIO (Nasdaq: RGNX) will present interim Phase II ALTITUDE trial data on suprachoroidal delivery of surabgene lomparvovec (sura-vec, ABBV-RGX-314) for diabetic retinopathy at the American Academy of Ophthalmology 2025 Annual Meeting. The presentation reports first-time 2-year results in non-proliferative diabetic retinopathy and is delivered by Charles C. Wykoff, M.D., PhD during Section IX: Late breaking developments, part I.

Presentation date/time: October 17, 2025 at 4:46 p.m. ET. Sura-vec is an investigational one-time gene therapy developed in collaboration with AbbVie for wet AMD and DR.

ROCKVILLE, Md., Oct. 9, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will present interim data from the Phase II ALTITUDE^® trial evaluating suprachoroidal delivery of surabgene lomparvovec (ABBV-RGX-314, sura-vec) for the treatment of diabetic retinopathy (DR) at the American Academy of Ophthalmology 2025 Annual Meeting. Sura-vec, developed in collaboration with AbbVie, is an investigational one-time gene therapy and potential first-in-class treatment for wet age-related macular degeneration (wet AMD) and DR.

Presentation: Suprachoroidal surabgene lomparvovec (sura-vec, ABBV-RGX-314): First time 2-year results in non-proliferative diabetic retinopathy
Presenter: Charles C. Wykoff, M.D., PhD, Retina Consultants of Texas
Session: Section IX: Late breaking developments, part I 
Date/Time: October 17, 4:46 p.m. ET

About Surabgene Lomparvovec (sura-vec, ABBV-RGX-314)
Sura-vec is being investigated as a potential one-time treatment for wet AMD, diabetic retinopathy and other chronic retinal conditions. Sura-vec consists of the NAV^® AAV8 vector, which encodes an antibody fragment designed to inhibit vascular endothelial growth factor (VEGF). Sura-vec is believed to inhibit the VEGF pathway by which new, leaky blood vessels grow and contribute to the accumulation of fluid in the retina.¹

ABOUT REGENXBIO Inc.
REGENXBIO is a biotechnology company on a mission to improve lives through the curative potential of gene therapy. Since its founding in 2009, REGENXBIO has pioneered the field of AAV gene therapy. REGENXBIO is advancing a late-stage pipeline of one-time treatments for rare and retinal diseases, including RGX-202 for the treatment of Duchenne; clemidsogene lanparvovec (RGX-121) for the treatment of MPS II and RGX-111 for the treatment of MPS I, both in partnership with Nippon Shinyaku; and surabgene lomparvovec (ABBV-RGX-314) for the treatment of wet AMD and diabetic retinopathy, in collaboration with AbbVie. Thousands of patients have been treated with REGENXBIO's AAV platform, including those receiving Novartis' ZOLGENSMA®. REGENXBIO's investigational gene therapies have the potential to change the way healthcare is delivered for millions of people. For more information, please visit www.REGENXBIO.com.

FORWARD-LOOKING STATEMENTS
This press release includes "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. These statements express a belief, expectation or intention and are generally accompanied by words that convey projected future events or outcomes such as "believe," "may," "will," "estimate," "continue," "anticipate," "assume," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would" or by variations of such words or by similar expressions. The forward-looking statements include statements relating to, among other things, REGENXBIO's future operations and clinical trials. REGENXBIO has based these forward-looking statements on its current expectations and assumptions and analyses made by REGENXBIO in light of its experience and its perception of historical trends, current conditions and expected future developments, as well as other factors REGENXBIO believes are appropriate under the circumstances. However, whether actual results and developments will conform with REGENXBIO's expectations and predictions is subject to a number of risks and uncertainties, including the timing of enrollment, commencement and completion and the success of clinical trials conducted by REGENXBIO, its licensees and its partners, the timing of commencement and completion and the success of preclinical studies conducted by REGENXBIO and its development partners, the timing or likelihood of payments from AbbVie or Nippon Shinyaku, the timely development and launch of new products, the ability to obtain and maintain regulatory approval of product candidates, the ability to obtain and maintain intellectual property protection for product candidates and technology, trends and challenges in the business and markets in which REGENXBIO operates, the size and growth of potential markets for product candidates and the ability to serve those markets, the rate and degree of acceptance of product candidates, and other factors, many of which are beyond the control of REGENXBIO. Refer to the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of REGENXBIO's Annual Report on Form 10-K for the year ended December 31, 2024, and comparable "risk factors" sections of REGENXBIO's Quarterly Reports on Form 10-Q and other filings, which have been filed with the SEC and are available on the SEC's website at WWW.SEC.GOV. All of the forward-looking statements made in this press release are expressly qualified by the cautionary statements contained or referred to herein. The actual results or developments anticipated may not be realized or, even if substantially realized, they may not have the expected consequences to or effects on REGENXBIO or its businesses or operations. Such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Readers are cautioned not to rely too heavily on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this press release. Except as required by law, REGENXBIO does not undertake any obligation, and specifically declines any obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Zolgensma^® is a registered trademark of Novartis Gene Therapies. All other trademarks referenced herein are registered trademarks of REGENXBIO.

CONTACTS:
Dana Cormack
Corporate Communications
Dcormack@regenxbio.com 

George E. MacDougall
Investor Relations
IR@regenxbio.com 

¹ Penn JS, Madan A, Caldwell RB, et al. Vascular endothelial growth factor in eye disease. Prog Retin Eye Res. 2008;27(4):331-71.

 

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SOURCE REGENXBIO Inc.

FAQ

What will REGENXBIO (RGNX) present at the AAO 2025 meeting on October 17, 2025?

REGENXBIO will present interim Phase II ALTITUDE 2-year results for suprachoroidal surabgene lomparvovec (sura-vec) in non-proliferative diabetic retinopathy.

Who is presenting REGENXBIO's sura-vec 2-year data at AAO 2025?

Charles C. Wykoff, M.D., PhD, Retina Consultants of Texas, is the listed presenter.

When and where is the sura-vec presentation scheduled at the AAO 2025 Annual Meeting?

The presentation is on October 17, 2025 at 4:46 p.m. ET during Section IX: Late breaking developments, part I.

What condition does sura-vec (ABBV-RGX-314) target in the REGENXBIO trial?

Sura-vec is being evaluated as a one-time gene therapy for diabetic retinopathy and wet age-related macular degeneration.

Which trial is providing the interim data for REGENXBIO's AAO 2025 presentation?

Interim data come from the Phase II ALTITUDE trial using suprachoroidal delivery of sura-vec.