Risk of cataract or raised intraocular pressure in patients treated with dexamethasone intravitreal implants: Results from a retrospective UK database study

Introduction: The association between the use of intravitreal implant of dexamethasone (DEX-I) and an increased risk of cataract, raised intraocular pressure (IOP) or glaucoma is well documented. However, data derived from clinical trial experience do not necessarily reflect the true incidence of adverse events in a broader population. We report on the results of an analysis from UK clinical database, drawing data from a population of patients receiving DEX-I for the treatment of diabetic macular oedema (DME), retinal vein occlusion with macular oedema (RVOME) or uveitis. Method(s): Anonymised data was extracted using electronic patient records from six UK eye clinics using either Medisoft or Medisight software systems. Adult patients who had received one or more DEX-I implant for any indication over the period 2011-2024 qualified for the study. An efficacy analysis exploring the impact of DEX-I implantation on visual outcomes was carried out and will be separately reported. For the safety analysis presented here, data regarding cataract and raised IOP or glaucoma were identified for each patient and association was determined by analyses of the time from DEX-I implantation to first occurrence of each safety event and the number of DEX-I injections administered. Result(s): A total of 4394 DEX-I treated eyes were identified in 3,942 patients, with a median follow-up of 5.88 years from the time of the first implant. Mean number of implants per eye was 2.21; range 1-26. The underlying diagnoses were DME (48%), RVO ME (48%) and uveitis (4%). Out of 1865 eyes that were phakic at the time of the first injection, a new cataract diagnosis was recorded in 411(22%) eyes. 72 (3.8%) of these occurred more than one year after the first implant and less than two years after the last implant and were thus considered attributable to DEX-I. Mean age at diagnosis was 67.3 years. Although the risk of cataract tended to rise in association with the number of implants administered, this trend was not statistically significant in this study (Chi squared =16.2; p =0.09). 656 (14.9%) out of 4394 DEX-I-treated eyes were identified as having an IOP > 30 mmHg, a new diagnosis of glaucoma, or received specific treatment for glaucoma up to 180 days following the last injection and these events were thus considered attributable to DEX-I. Of the DEX-I treated eyes, 12% received IOP-lowering drops for elevated IOP and0.4% required surgical or laser intervention. These rates were lower than those reported in pivotal clinical trials, where 23-41% of treated eyes required IOP lowering drops and up to 1.5% required surgery or laser. There was a significant association between the number of injections and the risk of a new OHT/glaucoma diagnosis, ranging from 8.7% of eyes with 1 DEX-I implant up to 38.0% of eyes that had received >=10 implants (Chi squared =215.4; p < 0.0001). Conclusion(s): In a large retrospective analysis of real-world evidence, use of DEX-I was shown to be associated with a lower risk of both new cataract diagnosis and increased intraocular pressure compared with the event rates observed in published clinical trials. Whilst IOP data was available for 4394 (81%) of patients, cataract may have been underreported due to various factors including the growth of Independent Treatment Centres. The risk of a new OHT/glaucoma diagnosis was associated with the number of injections received, but 97.3% of patients were adequately controlled without requiring laser or surgical intervention. These findings suggest potential differences between real-world safety outcomes for DEX-I, and clinical trial results, that may inform patient management strategies.

Citation

Pintard et al (2025). Risk of cataract or raised intraocular pressure in patients treated with dexamethasone intravitreal implants: Results from a retrospective UK database study. Eye 39 (Suppl 2), 191–318 (2025). https://doi.org/10.1038/s41433-025-03831-0

DOI

10.1038/s41433-025-03831-0

URI

https://hdl.handle.net/20.500.14709/1291