Imprimis Pharmaceuticals announced the release of data from a peer-reviewed study of patients receiving Imprimis' proprietary Dropless Therapy following cataract surgery, according to a company news release. The study evaluated 1,541 eyes from 922 patients and demonstrated that in nearly 92% of cases (n=1413/1541), supplemental medication was not required after surgery. The study retrospectively reviewed a case series of patients receiving cataract surgery and eligible for a transzonular injection of compounded Tri-Moxi-Vanc (3.0 mg triamcinolone acetonide, 0.2 mg moxifloxacin, 2.0 mg vancomycin).
"I have performed over 5,000 cataract surgeries since Imprimis' Tri-Moxi-Vanc (TMV) was first introduced and, with the exception of steroid responsive and advanced glaucoma patients, I exclusively use TMV as a prophylactic alternative for my patients undergoing cataract surgery. As a result, I have had the opportunity to retrospectively compile and analyze the largest case series to date evaluating the clinical benefits of TMV," Sydney Tyson, MD, SurgiCenter of Vineland, Vineland, New Jersey, said in the news release. "Although eye drops have been the current standard of care, there is a paradigm shift occurring as more surgeons are moving to single-use intraocular injections."
"Clinical outcomes after injection of a compounded pharmaceutical for prophylaxis after cataract surgery: a large-scale review" was a retrospective analysis of the medical records of 922 patients who underwent cataract surgery followed by an injection of TMV from November 2013 through December 2014. The primary analysis consisted of 1,541 surgical cases performed at a single-specialty ambulatory center (SurgiCenter of Vineland, Vineland, New Jersey). The study protocol was approved by the Wills Eye Hospital Institutional Review Board (Philadelphia, Pennsylvania, USA). Cases were evaluated preoperatively and at postoperative Days 1, 14-21, and 90 for visual acuity, intraocular pressure (IOP), and presence of endophthalmitis, inflammation and cystoid macular edema (CME).
The primary findings of the study included:
- No major intraoperative complications associated with the transzonular injection technique
- No cases of postoperative endophthalmitis
- Mean visual acuity was significantly increased at all postoperative visits (P<0.0001), including the day after surgery
- Rates of infection and inflammation reported appear similar to reported rates with alternative prophylactic therapies such as topical drops
- Rate of breakthrough inflammation at Days 14-21 was 9.2% (n = 132/1429)
- Rate of visually significant postoperative cystoid macular edema was 2.0% (n = 28/1429)
- Rate of clinically significant postoperative IOP increase was low: 0.9% (n = 13/1425) of cases had an increase of at least 10 mmHg in IOP at Days 14-21 or 90
- Only four of these cases had an IOP over 30 mmHg
The paper is available online now to subscribers and will be published in the January 2017 print issue of Current Opinion in Ophthalmology. The authors are Sydney L. Tyson, MD, MPH; Robert Bailey, MD; Janika San Roman, MPH, CCRP; Tingting Zhan, PhD; Lisa A. Hark, PhD, RD; and Julia A. Haller, MD. The authors received no financial support from Imprimis for the study. Dr. Tyson is a consultant for the company.