Favorable results of DexNP eye drops for DME in a phase II trial

REYKJAVÍK, ICELAND, AUGUST 3, 2015 – Dr. Akihiro Ohira, in co-operation with others, recently published in Acta Ophthalmologica the results of a phase II trial, comparing the use of DexNP, Oculis’ most advanced drug candidate, with conventional treatment with posterior subtenon injection of triamcinolone in patients with DME.

The trial demonstrates that topical DexNP eye drops significantly improve visual acuity and decrease macular thickness in patients with DME. The effect is similar to that from subtenon triamcinolone.

In this prospective, randomized, controlled trial, 22 eyes of 22 consecutive patients with DME were randomized to receive topical treatment with DexNP eye drops TID for 4 weeks then, BID for 4 weeks and then once daily for 4 weeks or one posterior subtenon injection of 20 mg triamcinolone acetonide. Study visits were at baseline and 4, 8, 12 and 16 weeks.

The logMAR (Snellen) visual acuity (mean ± SD) improved significantly with DexNP from 0.41 ± 0.3 (Snellen 0.39) to 0.32 ± 0.25 (0.48) and 0.30 ± 0.26 (0.50) at 4 and 8 weeks, respectively. One-third of the DexNP group improved more than 0.3 logMAR units. For triamcinolone, logMAR changed significantly from 0.42 ± 0.28 (0.38) at baseline to 0.32 ± 0.29 (0.48) at 4w and 0.33 ± 0.37 (0.47) at 12w.

The central macular thickness (CMT) decreased significantly with DexNP eye drops from 483 ± 141 m to 384 ± 142 μm at 4w and 342 ± 114 μm at 8w (29% reduction in CMT). For triamcinolone, CMT decreased significantly at all time-points: 494 ± 94 μm, 388 ± 120 μm, 388 ± 145 μm, 390 ± 136 μm and 411 ± 104 μm at 0, 4, 8, 12 and 16 weeks, respectively.

There was a modest increase in intraocular pressure (IOP) at all time-points with DexNP while no increase was seen with triamcinolone. Serum cortisol was affected by both treatments.

The paper published by Dr. Akihiro Ohira and his collaborators is titled “Topical dexamethasone γ-cyclodextrin nanoparticle eye drops increase visual acuity and decrease macular thickness in diabetic macular oedema” and is available online through Acta Ophthalmologica.

About Oculis

Oculis is a clinical-stage, privately held, pharmaceutical development company focusing on ophthalmic drugs and novel drug delivery to the eye. Oculis has developed a drug delivery platform consisting of a novel technique to facilitate drug absorption to both anterior and posterior parts of the eye. The advantage is a drug delivery system where diseases of the posterior part of the eye can be treated with a simple topical application, i.e. an eye drop.

For further information on Oculis, please visit: http://www.oculispharma.com