To report the early visual outcomes of eyes with a variety of retinal conditions that were treated with intravitreal faricimab during routine clinical practice in Latin America. Retrospective multicenter case series of 757 eyes of 732 patients who underwent at least one intravitreal injection of faricimab and had a least 4 weeks of follow-up. Our cohort consisted of 392 eyes with neovascular age-related macular degeneration (NV-AMD) (naive = 105; prior tx = 287); 225 with DME (naive = 74; prior tx = 151); 50 with central retinal vein occlusion (CRVO) (naive = 29; prior tx = 21); 20 with previously treated branch retinal vein occlusion (BRVO) and 69 (naive = 25; prior tx = 44) with other conditions. After a mean follow-up of 26.6 weeks and 4 injections, eyes with treatment naive NV-AMD eyes gained 9.1 letters (p < 0.0001) with a last mean treatment interval of 9.5 weeks. Previously-treated NV-AMD eyes gained 6.6 to 9.5 letters (p = 0.00146 and p < 0.0001) after a mean follow-up of 29 to 42 weeks and 3.8 to 4.3 injections with a last mean treatment interval of 9.2 to 12.1 weeks. In treatment naive diabetic macular edema (DME) eyes, after a mean follow-up of 24.8 weeks and 4.2 injections, there was a gain of 12 letters (p < 0.0001) with a last mean treatment interval of 9.2 weeks. In previously-treated DME eyes after a mean follow-up of 27.2 to 44.2 weeks and 3.8 to 3.9 to injections, there was a gain of 6.1 to 11.7 letters (p < 0.0001) with a last mean treatment interval of 9.6 to 15.2 weeks. Treatment-naive CRVO eyes gained 22.6 letters (p = 0.00369) after a mean follow-up of 26.2 weeks and 3.7 injections. Previously treated CRVO eyes gained 9.8 letters (0.5233) after a mean follow-up of 21.8 weeks and 3.4 injections. Previously-treated BRVO eyes gained 5.4 letters (p = 0.00862) after a mean follow-up of 28.1 weeks and 3.5 injections and a last treatment interval of 11.1 weeks. A total of 38 eyes discontinued treatment with faricimab and switched back to aflibercept. There were 3 cases of anterior uveitis that were treated with topical steroids. None of the eyes developed infectious endophthalmitis or occlusive retinal vasculitis. The early Latin American experience with faricimab is promising. On average treated eyes had functional and anatomic gains from baseline.
Objective:To primarily assess long-term safety and retinal imaging outcomes of NT-501 (revakinagene taroretcel-lwey), which releases ciliary neurotrophic factor into the vitreous over an extended time, for treating macular telangiectasia type 2 (MacTel). Design:Phase I, nonrandomized, multicenter, open-label extension study. Participants:Six participants with bilateral MacTel who completed the parent 60-month phase I study. Methods:In the parent study, participants had NT-501 surgically implanted in the study eye. The eye with more advanced disease was determined to be the study eye. For the purposes of this extension study, the fellow eye provided untreated natural history data. The extension study included visits 72, 84, 96, and 108 months postimplantation. Main Outcome Measures:Safety outcomes included adverse events (AEs), change from baseline in best-corrected visual acuity (BCVA), and the proportions of eyes with ≥10- or ≥15-letter loss in BCVA from baseline. Retinal imaging variables included change from baseline in ellipsoid zone (EZ) (inner segment/outer segment) area loss and proportion of study eyes with ≥35% increase from baseline in EZ area loss. Results:All implants were retained through the final study visit. All ocular treatment-emergent AEs were mild to moderate; none resulted in study discontinuation. No study eyes had ≥15-letter loss in BCVA from baseline at any study visit. Similarly, no study eyes had ≥10-letter loss at months 72, 84, and 96; 1 study eye (17%) experienced it at month 108. The portion of study eyes with a ≥35% increase in EZ area loss from baseline was lower (range, 50%-60%) relative to fellow eyes (range, 75%-100%). Conclusions:Over the 9-year follow-up period, NT-501 was well tolerated and safe. Further studies are ongoing to investigate the long-term efficacy of NT-501 for treating MacTel. Financial Disclosures:Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
