Icon begins pivotal late-stage trial of sustained-release postsurgery cataract treatment

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

Icon Biosciences has advanced its sustained-release therapy for inflammation after cataract surgery to a pivotal late-stage study. With one injection postsurgery, Icon's platform releases anti-inflammatory drugs that currently require multiple topical applications daily.

Icon's IBI-10090 releases the drug dexamethasone into the anterior chamber of the eye using the company's delivery technology Verisome, which can encapsulate the drugs in a solid, gel or liquid state using a small needle. Verisome is designed to be delivered with a small, 30-gauge needle, completely dissolve after treatment and allow constant monitoring by the physician.

In a previous IBI-10090 Phase II/III study, which involved 170 patients at three dosing strengths, patients showed significant anterior chamber cell clearing at day 8, and the company said that industry observers noted the treatment "showed favorable efficacy to commercially available topical treatments." These include dexamethasone products from Allergan ($AGN), Novartis ($NVS) and Bausch + Lomb, the company noted.

The current Phase III trial will test the drug in 390 patients. With half of the patients enrolled so far, the company expects to complete the trial later this year.

"The ongoing progression of IBI-10090 toward approval increasingly validates our strategy of pursuing a 505(b)(2) regulatory route to reduce product development risks by applying the Verisome technology to significantly expand the therapeutic value of an already approved drug entity such as dexamethasone," Icon CEO David Tierney said in a statement.

Early last year, Icon won the FDA's orphan drug designation for a melphalan formulation also using the Verisome platform to treat the childhood eye cancer retinoblastoma using a one-time injection.

- here's the release