Icon heralds late-stage success for extended-release, postsurgical cataract treatment

Ultrasound of Verisome formulation injected in the eye--Courtesy of Icon

Icon Bioscience has brought to light data from its late-stage extended-release cataract treatment, which demonstrated a high level of efficacy while reducing inflammation after surgery.

In the pivotal Phase III study, Icon's IBI-10090 showed in 394 patients aged 40 and older who had undergone cataract surgery to have reached its primary endpoint of clearing the anterior chamber of the eye for 8 days. At the two different doses, 63.1% and 66% of patients had clear anterior chambers at day 8 as compared to 25% in the placebo group, according to a release.

The candidate makes use of Icon's Verisome delivery technology to release the drug dexamethasone into the anterior chamber over time. Verisome is designed to encapsulate a drug within a solid, gel or liquid state and completely dissolve after treatment. A physician injects the treatment with a small, 30-gauge needle.

In an earlier study, Icon compared their IBI-10090 with currently available topical eyedrops. Companies in this space include Allergan ($AGN), Novartis ($NVS) and Bausch + Lomb, the company noted at the time. A longer-term treatment would conceivably help patients control their drug regimen, and for some patients eliminate the difficulty of administering their own eyedrops.

In 2013, Icon picked up an orphan designation for another one-injection Verisome candidate designed to treat retinoblastoma, a rare and aggressive form of childhood eye cancer, with the drug melphalan.

"In this Phase III trial, IBI-10090 showed unprecedented efficacy in reducing inflammation associated with cataract surgery, with a safety profile similar to that of placebo," New York University professor of ophthalmology Eric Donnenfeld said in a weekend presentation at the 2015 Annual ASCRS-ASOA Symposium and Congress. "IBI-10090 could prove to be an important new therapy as an alternative to frequent corticosteroid drop instillation in post-cataract surgical care."

- here's the release