Diabetic retinopathy (DR)
RGNXRegenxbioCatalyst overview
Research summary
This catalyst tracks a Phase 2/3 update for Surabgene lomparvovec (sura-vec, ABBV-RGX-314) (Suprachoroidal Delivery) in Diabetic retinopathy (DR). The expected timing is based on the latest available company guidance and may change.
ALTITUDE® trial. Collab w/ AbbVie. 10/21/24- Ph2 data result at AAO 2024. 3/13/25- Ongoing enrollment in Ph2 portion. Plans further the development to Ph3. 10/9/25- Present interim data at AAO'25 on Oct 17th.11/06/25:- Company plans to initiate a two-part sham-controlled Phase IIb/III global pivotal trial in diabetic retinopathy with site selection in progress, supported by durable two-year Phase II ALTITUDE data; timing for trial initiation remains unspecified. 01/11/26:- Planned Phase IIb/III DR suprachoroidal trial initiation; first patient dosing expected H1 2026, triggering $100M AbbVie milestone. 03/05/26:- NAAVIGATE Phase IIb/III DR trial sites activating; first patient dosing and $100M AbbVie milestone expected Q2 2026. 05/14/26:- NAAVIGATE Phase IIb/III DR sites now active and initiating enrollment; first patient dosing still expected Q2 2026. 06/29/26:- First NAAVIGATE Ph2b/3 DR patient dosed; $100M milestone. Present ALTITUDE 2.5-year data at ASRS July 2026. 07/18/26:- ALTITUDE NPDR 2.5-year Dose Level 3 data showed durable DRSS gains; no intraocular inflammation. Same dose used in NAAVIGATE Ph2b/3. 08/06/26:- NAAVIGATE Ph2b/3 ongoing; AbbVie milestone received July 2026.
Verification
Confirm timing and program details against the company announcement or filing.