Mark your calendars! REGENXBIO will present key insights on surabgene lomparvovec during an investor event on October 20, 2026, shedding light on its pivotal trials.

This article discusses the promising three-year follow-up results of surabgene lomparvovec for addressing diabetic retinopathy. The study highlights potential advancements in treatment options.

Reported Thursday, Sep 24 - 8:52pm EDT (TheFly subscription required to read more.)

RGX-202 BLA submission for Duchenne muscular dystrophy on track for Q3 2026 initiation, with potential accelerated approval in 2H 2027 Long-term surabgene lomparvovec (sura-vec, ABBV-RGX-314) data highlight durable safety and efficacy profile ahead of key catalyst Topline data from...

A gene therapy for neovascular age-related macular degeneration in the second eye shows safety and preservation of vision and anatomy a year after the first eye was treated.

Reported Sunday, Jul 19 - 11:40am EDT (TheFly subscription required to read more.)

One-time gene therapy treatment with sura-vec demonstrated long-term efficacy at similar doses to those being evaluated in ongoing late-stage studies:Stable to improved vision through 5 years in wet AMD patients who required frequent anti-VEGF injections prior to one-time... The post REGENXBIO Presents Positive Long-Term Data for Surabgene Lomparvovec in Wet AMD and Diabetic Retinopathy at American Society of Retina Specialists Annual Meeting appeared first on Diario Palm Beach .

REGENXBIO has announced promising long-term data for their gene therapy, surabgene lomparvovec, in treating wet AMD and diabetic retinopathy at the ASRS meeting.

REGENXBIO Inc. has wrapped up participant enrollment in pivotal studies for its gene therapy aimed at treating wet AMD. This marks a significant step in fighting vision loss globally.

REGENXBIO has announced the initiation of a crucial Phase IIb/III clinical trial for surabgene lomparvovec aimed at treating diabetic retinopathy.

One-time gene therapy treatment with sura-vec demonstrated long-term efficacy at similar doses to those being evaluated in ongoing late-stage studies: Stable to improved vision through 5 years in wet AMD patients who required frequent anti-VEGF injections prior to one-time sura-vec; no drug-related IOI observed in a setting of no prophylactic...

ROCKVILLE, Md., June 29, 2026/ PRNewswire/-- REGENXBIO Inc. today announced the first patient has been dosed in the Phase IIb/III NAAVIGATE clinical trial of investigational surabgene lomparvovec in diabetic retinopathy using suprachoroidal delivery. REGENXBIO will receive $100 million from AbbVie for this milestone. Current treatment options often...

Company announced positive topline results from pivotal Phase III AFFINITY DUCHENNE ® study of RGX-202 Primary endpoint achieved with high statistical significance Statistically significant correlation between RGX-202 microdystrophin expression and functional improvement, supporting validity of surrogate endpoint Surabgene lomparvovec on...

Late-stage gene therapy pipeline for rare and retinal diseases advancing toward key catalysts RGX-202 for Duchenne muscular dystrophy: New Phase I/II data at MDA, topline pivotal results expected early Q2 2026 Robust patient enrollment continues in confirmatory trial Surabgene lomparvovec subretinal wet AMD topline pivotal data expected in Q4 2026;...

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.

REGENXBIO (Nasdaq: RGNX) announced completion of enrollment in the ATMOSPHERE and ASCENT pivotal trials of subretinal surabgene lomparvovec for wet age-related macular degeneration (wet AMD).Combined enrollment exceeded 1,200 participants across >200 sites worldwide, making this the largest global gene therapy program reported for an ocular indication. ATMOSPHERE (U.S.) compares sura-vec to ranibizumab; ASCENT (U.S. + 13 countries) compares sura-vec to aflibercept. Primary endpoints are non-inferiority in BCVA at 54 weeks and one year. Company cites durable effects up to 4 years in long-term follow-up and no drug-related serious adverse events in a 60-patient Phase II study. Topline pivotal data expected Q4 2026.

REGENXBIO (NASDAQ:RGNX) announced the advancement of surabgene lomparvovec (sura-vec) into a pivotal Phase IIb/III clinical trial for diabetic retinopathy (DR) using suprachoroidal delivery. The decision follows positive two-year data from the Phase II ALTITUDE® trial, demonstrating durable safety and efficacy with a single injection.Under an amended collaboration with AbbVie, REGENXBIO will receive $100 million upon first subject dosing in the Phase IIb/III trial and another $100 million for the first subject in a second Phase III trial. The Phase II ALTITUDE trial showed favorable safety results, with no drug-related serious adverse events or intraocular inflammation observed through two years at dose level 3.

One-time gene therapy treatment with sura-vec demonstrated long-term efficacy at similar doses to those being evaluated in ongoing late-stage studies: Stable to improved vision through 5 years in wet AMD patients who required frequent anti-VEGF injections prior to one-time sura-vec; no...

New long-term data from diabetic retinopathy and wet AMD programs to be presented at American Society of Retina Specialists (ASRS) 2026 ROCKVILLE, Md., June 29, 2026 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the first patient has been dosed in the Phase IIb/III...

The wet AMD market is expected to grow due to the increasing diagnosed cases of Wet-AMD, the current therapies, and the launch of emerging therapies such as Ixoberogene soroparvovec (Ixo-vec) (Adverum Biotechnologies), Surabgene lomparvovec (RGX-314) (Regenxbio/AbbVie), OGX-110...

Late-stage gene therapy pipeline for rare and retinal diseases advancing toward key catalysts RGX-202 for Duchenne muscular dystrophy: New Phase I/II data at MDA, topline pivotal results expected early Q2 2026 Robust patient enrollment continues in confirmatory trial Surabgene lomparvovec...

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...

Over 1,200 participants enrolled in ATMOSPHERE® and ASCENT® pivotal trials, representing largest global gene therapy program ever conducted Subretinal surabgene lomparvovec on track to be first gene therapy for wet AMD Topline pivotal data expected in Q4 2026 ROCKVILLE, Md., Oct. 6, 2025...

A pivotal Phase IIb/III clinical trial using suprachoroidal delivery for treatment of diabetic retinopathy will be initiated New Phase II ALTITUDE® trial data demonstrate a durable safety and efficacy profile observed through two years with a single, in-office injection of surabgene...