Investigational ABBV-RGX-314 using suprachoroidal delivery is designed as a one-time, in-office treatment.

The new data presented includes six-month results from two additional dose level 3 cohorts (Cohorts 5 and 6). 

ABBV-RGX-314, being developed in collaboration with AbbVie Inc (NYSE:ABBV), is also being investigated as a potential one-time gene therapy for diabetic retinopathy and other chronic retinal conditions.

ABBV-RGX-314 continues to be well tolerated in over 100 patients from three dose levels with no drug-related serious adverse events

ABBV-RGX-314 in over 50 patients at the third dose level demonstrated the highest reduction in treatment burden:

• 80% reduction in annualized injection rate.
• 50% injection-free.

Zero cases of intraocular inflammation were observed in patients who received short-course prophylactic topical steroid eye drops.

Baird writes that while pivotal data for RGX-314 is anticipated in about two years, the forthcoming results from the suprachoroidal administration in age-related macular degeneration (AMD) and diabetic retinopathy (DR) during the second half of 2023 are expected to provide valuable insights. 

These results could potentially support the program’s transition from a subretinal operative procedure to an in-office administration, presenting a significant improvement in commercial potential. 

JMP Securities notes that the six-month data update from Cohorts 5 and 6 provides additional evidence that ocular gene therapy can be effectively and safely delivered to the suprachoroidal space via Clearside Biomedical Inc’s (NASDAQ:CLSD) Microinjector, which would be paradigm-shifting for the field. 

Price Action: RGNX shares are down 7.98% at $14.05 on the last check Wednesday.