| Presentation preference | Oral presentation |
| Title | A novel intravitreal anti-IL-6 monoclonal antibody for uveitic macular edema (UME): preliminary results from the phase 1 DOVETAIL study |
| Purpose | Interleukin-6 (IL-6) is a key cytokine involved in uveal inflammation. This abstract reports preliminary data from RG6179, an intravitreal (IVT) anti-IL-6 antibody, in patients with uveitic macular edema. |
| Methods | DOVETAIL is an ongoing phase 1, multicenter, non-randomized, open-label, multiple ascending dose study that investigates the safety, tolerability, efficacy, and PK/PD profile of RG6179 in both diabetic macular edema (DME) and UME patients. Patients ≥18 years with NIU and concurrent ME (CST ≥325 µm) were included (N=33). Patients were enrolled into 3 dose groups: 0.25 mg (n=10), 1 mg (n=10), and 2.5 mg (n=13), and received IVT RG6179 at Week 0, 4 and 8, followed by post-treatment observation until Week 36. |
| Results | Mean (SE) BCVA change from baseline was +10.3 (2.6), +9.5 (2.1) and +8.4 (3.1) letters for the 0.25, 1 and 2.5 mg doses, respectively, with a combined mean of +9.3 (1.6) letters at 12 weeks. Mean CST change from baseline was -124 (44), -177 (59) and -184 (48) μm, respectively, with a combined mean of -161 (28) μm at 12 weeks. Of note, the BCVA and CST benefits were maintained during the post-treatment observation period. All doses of RG6179 were well tolerated across all 33 patients. Ocular AEs (n=27) were reported in the study eye of 16 of 33 patients. There were no cases of treatment-related intraocular pressure increase, new cataracts, occlusive retinal vasculitis, or systemic AEs. |
| Conclusion | This phase 1 trial provides preliminary data on the safety and efficacy of the novel IVT anti–IL-6 antibody RG6179 in patients with UME. Phase 2 (DME) and phase 3 trials (UME) are currently underway. |
| Conflict of interest | Yes |
| Details of conflicting interests | CD: Consultant: Alimera, Santen; Lectures: AbbVie, Alimera, Allergan, Amgen, Santen, Thea, Novartis; Clinical trials: Panoptes, Roche, Tarsier SS: Roche, Genentech, Alimera, Abbvie, Eyepoint, Clearside, Regeneron, Bausch and Lomb, RegenxBio (consultant for all); Roche, Genentech, Eyepoint, IONIS, Gliead, Santen (Research support) ES: Consultant: Roche, Abbvie, Clearside, EyePoint, Gilead, Kriya. Research Support: Roche, Abbvie, Clearside, EyePoint, Gilead PL: Roche/Genentech, Bausch & Lomb (consultant) MP-E, DW, ZD, DS, SF, MM: employees of Roche |
| Last name | DEUTER |
| Initials of first name(s) | C |
| Department | Centre for Ophthalmology, University Hospital Tübingen |
| City | Tübingen |
| Country | Germany |
| Last name | Sharma |
| Initials of first name(s) | S |
| Department | Cole Eye Institute, Cleveland Clinic |
| City | Cleveland |
| Country | United States |
| Last name | Suhler |
| Initials of first name(s) | E |
| Department | Casey Eye Institute, Oregon Health & Science University |
| City | Portland |
| Country | United States |
| Last name | Lin |
| Initials of first name(s) | P |
| Department | Cole Eye Institute, Cleveland Clinic |
| City | Cleveland |
| Country | United States |
| Last name | Pauly-Evers |
| Initials of first name(s) | M |
| Department | F. Hoffmann-La Roche AG |
| City | Basel |
| Country | Switzerland |
| Last name | Willen |
| Initials of first name(s) | D |
| Department | F. Hoffmann-La Roche AG |
| City | Basel |
| Country | Switzerland |
| Last name | Haskova |
| Initials of first name(s) | Z |
| Department | Genentech, Inc. |
| City | South San Francisco |
| Country | United States |
| Last name | Silverman |
| Initials of first name(s) | D |
| Department | F. Hoffmann-La Roche AG |
| City | Basel |
| Country | Switzerland |
| Last name | Fauser |
| Initials of first name(s) | S |
| Department | F. Hoffmann-La Roche AG |
| City | Basel |
| Country | Switzerland |
| Last name | Mesquida |
| Initials of first name(s) | M |
| Department | F. Hoffmann-La Roche AG |
| City | Basel |
| Country | Switzerland |
| Last name | Peck |
| Initials of first name(s) | R |
| Department | F. Hoffmann-La Roche AG |
| City | Basel |
| Country | Switzerland |
| Last name | Holmes |
| Initials of first name(s) | W |
| Department | F. Hoffmann-La Roche AG |
| City | Basel |
| Country | Switzerland |
| Last name | Storti |
| Initials of first name(s) | F |
| Department | F. Hoffmann-La Roche AG |
| City | Basel |
| Country | Switzerland |
| Last name | Rauhut |
| Initials of first name(s) | S |
| Department | F. Hoffmann-La Roche AG |
| City | Basel |
| Country | Switzerland |
| Last name | Gott |
| Initials of first name(s) | T |
| Department | F. Hoffmann-La Roche AG |
| City | Basel |
| Country | Switzerland |
| Last name | Passemard |
| Initials of first name(s) | B |
| Department | F. Hoffmann-La Roche AG |
| City | Basel |
| Country | Switzerland |