Imprimis Pharmaceuticals’ ophthalmology compounding division, ImprimisRx, has announced the findings from a study published in the Journal of Cataract and Refractive Surgery that followed 483 eyes with glaucoma that were undergoing cataract surgery with concomitant trabecular microbypass stent insertion. The study was initially presented at the American Society of Cataract and Refractive Surgery (ASCRS) and examines post-surgery outcomes for patients receiving an intravitreal injection of steroid and antibiotics at the time of surgery compared with a standard drop regimen following surgery.
All study participants were diagnosed with primary open-angle glaucoma and received a glaucoma stent at the time of surgery in parallel with the cataract surgery procedure. The study group of 234 eyes received an intravitreal injection (pars plana) of 0.2 mL of »Dropless, a combination of steroid and antibiotics, at the time of surgery. The control group of 249 eyes received a standard topical regimen postoperatively.
To evaluate safety, the incidence of IOP spikes was also recorded, which was defined as an increase of at least 15 mm Hg from baseline IOP. There was no statistically significant difference in the rate of IOP spikes between the two groups. The safety profiles of both groups were favorable. In the study group, there were no reported cases of inflammation, cystoid macular edema (CME), infection or retinal detachments.
“The publication of this study of one of our Dropless formulations in one of the most prestigious peer-reviewed ophthalmology journals validates the experiences of hundreds of thousands of patients over the past four years,” Imprimis CEO Mark L. Baum said in a company news release. “This formulation continues to be an important option for patients and doctors alike, to help reduce or eliminate the need for post-surgery eye drop regimens and the potential for complications with medication adherence.”