Abbvie (ABBV) announced an update on their ongoing clinical study.
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AbbVie is launching an ambitious late-stage eye study called NAAVIGATE, formally titled “An Operationally Seamless Phase 2b/3, Multicenter, Randomized, Masked, Sham-controlled Study to Evaluate the Efficacy and Safety of Surabgene Lomparvovec (Sura-vec) Delivered Via Suprachoroidal Space (SCS) Injection Targeting Subjects With Diabetic Retinopathy Without Center Involved-Diabetic Macular Edema (CI-DME) (NAAVIGATE).” The goal is to see if a one-time gene therapy can slow or prevent vision loss in adults with diabetic retinopathy who do not yet have swelling in the center of the retina.
The main treatment tested is surabgene lomparvovec, also called sura-vec. It is designed as a one-time gene therapy injected into the layer just outside the retina, aiming to cut the long-term risk of vision-threatening events and reduce the need for frequent eye injections.
Participants are split into groups that get either sura-vec plus steroid eye drops or a sham injection with artificial tears, with some later allowed to cross over into the active treatment arm. The study uses a randomized, parallel-group setup with double-masking of both patients and outcome assessors, and its main purpose is to test treatment benefit and safety compared with a sham procedure.
The trial started recruiting after initial submission on 2026-04-24, marking the formal launch of the Phase 2b/3 program. The most recent update on 2026-05-18 signals that AbbVie is actively refining trial details as enrollment progresses toward long-term primary and final completion, which will extend follow-up to five years after dosing in each eye.
For investors, this update underscores AbbVie’s push to build a durable position in retinal disease with a high-risk, high-reward gene therapy play. Success could expand ABBV’s ophthalmology portfolio and pressure rivals in diabetic eye disease, while setbacks could temper enthusiasm for longer-dated growth in this niche but growing segment.
The NAAVIGATE study is currently ongoing and updated, with further details available on the ClinicalTrials portal.
To learn more about ABBV’s potential, visit the Abbvie drug pipeline page.