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OMS302 use during cataract surgery in subjects with diabetes mellitus

Poster Details

First Author: D.Schaaf USA

Co Author(s):    S. Whitaker   G. Demopulos           

Abstract Details

Purpose:

Over 25% of individuals with diabetes mellitus (DM) also develop concomitant cataract disease. During cataract surgery, these individuals experience a greater incidence of intraoperative miosis compared to those without DM, which puts them at greater risk for complications such as vitreous loss and worsening diabetic macular edema. The effect of OMS302, a drug product comprised of phenylephrine and ketorolac, on maintenance of pupil dilation in subjects with DM undergoing cataract surgery was evaluated in a retrospective subgroup analysis of pooled data from one Phase 2 and two Phase 3 clinical trials.

Setting:

Use of OMS302 in subjects undergoing cataract extraction and lens replacement or refractive lens exchange was evaluated in a total of three prospective, controlled, randomized Phase 2 and Phase 3 clinical trials of OMS302 conducted in the United States and the Netherlands. Analysis conducted by Omeros Corporation, USA, using pooled data from 3 multi-center, randomized, controlled trials.

Methods:

During each trial, OMS302 or placebo was added to balanced salt solution (BSS®) and administered intracamerally as part of routine irrigation to subjects during cataract surgery. Each procedure was video recorded and intraoperative pupil dilation was measured by a single, masked reader at one-minute intervals from just prior to initial incision through immediately following incision closure. All subjects were followed for safety for at least 14 days postoperatively. Subjects with DM were identified by review of medical history and concomitant medication use. Pupil diameter and safety results were evaluated in the two populations (subjects with DM and subjects without DM).

Results:

Of 919 subjects included in the analysis, 184 (105 placebo and 79 OMS302) were identified with concurrent DM. Among these, only 10/74 (13.5%) OMS302 subjects experienced intraoperative constriction of pupil diameter to <6 mm at any time during the procedure compared to 49/97 (50.5%) of placebo subjects (p<0.0001), and no OMS302 subjects experienced intraoperative pupillary constriction ≥2.5 mm versus 29/97 (29.9%) placebo subjects (p<0.0001). Common adverse events included eye pain (57/184 [31.0%]), eye inflammation (33/184 [17.9%]), headache (10/184 [5.4%]), and anterior chamber inflammation (9/184 [4.9%]). These results were consistent with those seen in the study subjects without DM.

Conclusions:

Results of this pooled analysis demonstrated that OMS302 had a significant effect on maintenance of pupil diameter during cataract surgery or refractive lens exchange. For both subjects with DM and subjects without DM, OMS302 was superior to placebo in preventing intraoperative miosis. OMS302 was also safe in both patient populations.

Financial Disclosure:

One or more of the authors gains financially from product or procedure presented, One or more of the authors travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, One or more of the authors is employed by a for-profit company with an interest in the subject of the presentation, One or more of the authors has significant investment interest in a company producing, developing or supplying product or procedure presented

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