Efficacy and safety of OTX-101, a novel nanomicellar cyclosporine formulation, in patients with conjunctivitis sicca: results of a pooled secondary analysis

Session Details

Session Title: Cornea: Medical

Session Date/Time: Monday 16/09/2019 | 08:30-10:30

Paper Time: 09:00

Venue: Free Paper Forum: Podium 2

First Author: : J.Luchs USA

Co Author(s): :    A. Ogundele    B. Schechter    D. Evans    S. Kannarr    J. Sheppard    C. Darby    P. Karpecki            

Abstract Details

Purpose:

Keratoconjunctivitis sicca (KCS) is a multifactorial disease of the ocular surface and is the most common reason for seeking medical eye care. OTX-101—a novel nanomicellar cyclosporine A formulation—is approved in the US for increasing tear production in patients with KCS. We present a pooled analysis of a phase 2b/3 and a phase 3 study evaluating efficacy and safety of OTX-101 0.09% in the worse study eye in patients with KCS.

Setting:

The phase 2b/3 study was carried out at 29 sites and the phase 3 study was carried out at 45 sites, all in the United States.

Methods:

In these randomized, vehicle-controlled studies, patients received 1 drop OTX-101 or vehicle in both eyes twice daily. Pooled efficacy endpoints included percentage of eyes with ≥10-mm Schirmer’s score increase from baseline at day 84 and mean change from baseline in total conjunctival staining at days 28, 56, and 84. Conjunctival staining was scored in 6 individual zones; inferior zones were averaged then added to medial and lateral zones for the total score (excluding superior zones). Worse eye was defined for each assessment as eye with worse score, or right eye if equal. Pooled safety assessments included adverse event monitoring.

Results:

Pooled analyses included 523 and 525 patients receiving OTX-101 and vehicle, respectively. Percentage of eyes with ≥10-mm increase in Schirmer’s score at day 84 was 19.1% vs 11.0% for OTX-101 and vehicle, respectively (P=0.0003). At day 84, the mean change from baseline in total conjunctival staining score ± standard deviation was −1.7 ± 2.2 vs −1.2 ± 2.3 for OTX-101 vs vehicle, respectively (P=0.0006). The difference between treatment groups was statistically significant at all time points (day 28 P=0.0202, day 56 P=0.0002). Instillation site pain was the most common adverse event (21.8% vs 4.0% for OTX-101 vs vehicle, respectively).

Conclusions:

Treatment with OTX-101 0.09% showed improvement in objective signs of KCS in these pooled analyses, as evidenced by significant improvement in tear production and conjunctival staining vs vehicle. A statistically significant improvement in conjunctival staining was seen as early as day 28 and continued through day 84. OTX-101 0.09% was well tolerated in patients with KCS.

Financial Disclosure:

is employed by a for profit company with an interest in the subject of the presentation, travel has been 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