Two posters to be presented at AAO 2019 will look at safety and satisfaction associated with intravitreal implants and intravitreal injections, respectively.
The first, “Global Safety Update: Long-Term IOP Outcomes in Patients Receiving the Fluocinolone Acetonide Intravitreal Implant,” presents data from the 2018 Periodic Safety Update Report/ Periodic Benefit Risk Evaluation Report (PSUR/PBRER), which evaluated real-world, long-term safety data for the fluocinolone acetonide (FAc) intravitreal implant (Iluvien). The August 2018 PSUR/PBRER for FAc implant encompasses data from the U.S.-based Phase 4 IOP Signals Associated with ILUVIEN Study (PALADIN), U.S. retrospective chart review (USER), and non-U.S. studies (Retro IDEAL, IRISS and MEDISOFT), as well as global spontaneous reporting data.
The research included 18,082 eyes that received an FAc intravitreal implant; 69 (0.38%) eyes required incisional surgery. Per data from the FAME trials, out of 375 eyes, 18 (4.8%) required incisional surgery. The FAME trials reported a higher rate of trabeculoplasty (n = 4, 1.1%) than the PSUR/PBRER (n = 40, 0.22%).
“The PSUR/ PBRER did not identify any significant safety signals that would potentially impact the FAc implant safety profile,” the researchers concluded. “These data confirm IOP safety outcomes of the FAc implant across multiple countries and DME labels.”
The second scientific poster, “Assessing Patient Comfort and Antimicrobial Efficacy Using Aqueous Chlorhexidine vs. Povidone Iodine Prior to Bilateral Intravitreal Injection,” acknowledged that povidone iodine is a common antiseptic used in intravitreal injections but often causes discomfort, whereas aqueous chlorhexidine has been more well-tolerated. The randomized study compared the two techniques.
The patient population included participnts receiving bilateral intravitreal injections with either povidone iodine or aqueous chlorhexidine antiseptic. Researchers performed a bacterial culture before and after antiseptic use, and a standardized ocular staining score (OSS) was used to record a fluorescein exam. Pain was self-reported using a 10-point scale one minute and one day after the procedure.
Final analysis included 100 eyes of 50 patients. The povidone iodine eyes reported a greater post-injection pain score (P < 0.001), as well as greater OSS (P < 0.001). Adverse events and culture positivity rates did not differ between the groups.