Safety and efficacy of a dexamethasone intracanalicular insert (0.4 mg) for the treatment of ocular pain and inflammation after cataract surgery

Session Details

Session Title: Cataract Surgery: Complications & Management

Session Date/Time: Tuesday 17/09/2019 | 14:00-16:00

Paper Time: 14:06

Venue: Free Paper Forum: Podium 1

First Author: : J. Hovanesian USA

Co Author(s): :    E. Donnenfeld    J. Berdahl   F. Mah   T. Walters   S. Bafna   S. Vantipalli   J. Metzinger    M. Goldstein        

Abstract Details

Purpose:

To evaluate the safety and efficacy of DEXTENZA® (dexamethasone ophthalmic insert) in the treatment of post-surgical pain and inflammation following cataract surgery.

Setting:

Integrated analysis of three phase 3, prospective, multicenter, double-masked clinical trials.

Methods:

At the time of cataract surgery, 926 patients were randomized to receive DEXTENZA (n=541) or placebo vehicle (PV; n=385) at 58 US sites; follow-up visits occurred on postoperative days 2, 4, 8, 14, 30, and either day 45 or 60, depending on the trial protocol. Absence of pain (score of 0) at day 8 and absence of anterior chamber cells (ACC) at day 14 were primary efficacy end points. Assessment of safety was based on extent of exposure, adverse events (AEs), visual acuity, intraocular pressure, slit lamp, punctum exam, and fundoscopy.

Results:

DEXTENZA was effective in preventing ocular pain. On day 2, a significantly greater proportion of DEXTENZA patients reported no pain. On day 8, 79.2% of DEXTENZA patients and 56.9% of PV patients reported no pain (P<0.0001). DEXTENZA was also effective in reducing inflammation: 42.7% of DEXTENZA patients had no ACC at day 14 vs 27.5% of PV patients (P<0.0001). Statistical differences were seen for absence of AC flare, trace cell or less, mean ACC, and AC flare. AEs reported in the DEXTENZA group were mild or moderate. The most common ocular AEs were eye/AC inflammation and increased IOP.

Conclusions:

This integrated analysis of three phase 3 clinical trials of DEXTENZA for postsurgical pain and inflammation demonstrated that DEXTENZA was significantly more effective than PV in treating ocular pain at Day 8 and in treating inflammation at Day 14. In addition, DEXTENZA was superior to PV for the secondary end points of absence of AC flare, trace cell or less, mean ACC, and AC flare. The safety profile of DEXTENZA was consistent with that of topical ocular steroids following cataract surgery.

Financial Disclosure:

is employed by a for profit company with an interest in the subject of the presentation, research is funded, fully or partially, by a competing company, research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, receives consulting fees, retainer, or contract payments from a competing company, receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented