Severe Intraocular Inflammation Following Intravitreal Faricimab

Abstract

Importance: Monitoring for and reporting potential cases of intraocular inflammation (IOI) in clinical practice despite limited occurrences in clinical trials, including experiences with relatively new intravitreal agents, such as brolucizumab, pegcetacoplan, or faricimab, helps balance potential benefits and risks of these agents.

Objective: To provide descriptions of 3 initially culture-negative cases of acute, severe, posterior-segment IOI events occurring within the same month following intravitreal faricimab injections at a single institution.

Design, setting, and participants: In this case series, 3 patients manifesting acute, severe IOI following intravitreal injection of faricimab were identified between September 20, 2023, and October 20, 2023.

Exposure: Faricimab, 6 mg (0.05 mL of 120 mg/mL solution), for neovascular age-related macular degeneration among patients previously treated with aflibercept; 1 patient also had prior exposure to bevacizumab.

Main outcomes and measures: Visual acuity, vitreous taps for bacterial or fungal cultures, and retinal imaging.

Results: All 3 patients received intravitreal faricimab injections between September 20 and October 20, 2023, from 2 different lot numbers (expiration dates, July 2025) at 3 locations of 1 institution among 3 of 19 retina physicians. Visual acuities with correction were 20/63 OS for patient 1, 20/40 OD for patient 2, and 20/20 OS for patient 3 prior to injection. All 3 patients developed acute, severe inflammation involving the anterior and posterior segment within 3 to 4 days after injection, with visual acuities of hand motion OS, counting fingers OD, and hand motion OS, respectively. Two patients were continuing faricimab treatment while 1 patient was initiating faricimab treatment. All received intravitreal ceftazidime, 2.2 mg/0.1 mL, and vancomycin, 1 mg/0.1 mL, immediately following vitreous taps. All vitreous tap culture results were negative. One patient underwent vitrectomy 1 day following presentation. Intraoperative vitreous culture grew 1 colony of Staphylococcus epidermidis, judged a likely contaminant by infectious disease specialists. All symptoms resolved within 1 month; visual acuities with correction were 20/100 OS for patient 1, 20/50 OD for patient 2, and 20/30 OS for patient 3.

Conclusions and relevance: In this case series, 3 patients with acute, severe IOI within 1 month at 3 different locations among 3 ophthalmologists of 1 institution following intravitreal faricimab could represent some unknown storage or handling problem. However, this cluster suggests such inflammatory events may be more common than anticipated from faricimab trial reports, emphasizing the continued need for vigilance to detect and report such cases following regulatory approval.

Figure 1.. Timeline of Patient 1 From Presentation to Resolution of Inflammation

A, Ultra-widefield fundus image of patient 1 shows vitreous debris and intraretinal hemorrhages on presentation with vitreous opacities. B, No retinal detachment was noted on B-scan ultrasonography when visual acuity with correction had decreased from 20/63 OS at his visit immediately preceding his last intravitreal injection to hand motion OS at this visit. C, Two weeks after receiving faricimab and treatment for vitritis, there was marked reduction of vitreous debris with an improved view of the retina. D, Six weeks following his presentation with vitritis, visual acuity with correction improved to 20/100 OS associated with development of macular epiretinal membranes with progressive macular traction as well as recurrence of interstitial fluid on optical coherence tomography, potentially from his neovascular age-related macular degeneration or an effect of the macular traction or both.

Figure 2.. Optical Coherence Tomography Abnormalities in Patient 3

A, Optical coherence tomography of patient 3 on postoperative day 2 following vitrectomy with anterior chamber washout and repeated intravitreal injection of antibiotics showed clearing of vitreous cavity debris with a pigment epithelial detachment similar to what was noted 1 month previously. B, Three weeks after presenting with vitritis and following resolution of inflammation, optical coherence tomography showed recurrence of subretinal fluid associated with neovascular age-related macular degeneration.