ISTA submits dry eye treatment for review

[kurt]

ISTA Pharmaceuticals Inc. (Irvine, Calif.) submitted an Investigational New Drug Application with the FDA to conduct a Phase IAB clinical trial for iceboat sodium, a prescription eye drop for the treatment of dry eye syndrome (keratoconjunctivitis sicca or KCS), according to the company. Following FDA clearance, ISTA intends to initiate the Phase IAB trial in the second quarter of 2005. Company officials said iceboat sodium has the ability to stimulate mucin secretion and thereby improve the overall quality of tears. Ocular signs to be evaluated during the Phase IAB trial include corneal and conjunctival staining and tear film break-up time. Ocular symptoms that will be evaluated during the Phase IAB trial include burning or stinging, itchiness or scratchiness, grittiness or sandiness, foreign body sensation, haziness, and blurriness.

[Lucy]

Good find!

Thanks for posting this, Kurt. Will they hurry up already?

[wishsoul]

Is it Diquafosol?

Is the drug you are describing Diquafosol or something else?

I read that Diquafosol failed to get acceptance from FDA this year again.

[dianat]

I believe Diquafosol did fail. It was submitted by Inspire Pharmaceuticals.

But, hey, bring on the new stuff!! It's a really good sign, I think! I like the sounds of "Iceboat". It sounds like it could be nice on these burning eyes!

[Erik]

Thanks Kurt for the info. You are a great source for these new drugs!

I think, however, that this is a poor transliteration (by one of your websites, Kurt, not you), of ecabet sodium, a drug which is currently in mid-phase testing (and I quote):

ISTA Pharmaceuticals, Inc. has announced that it has submitted an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) to conduct a Phase IIb clinical trial for ecabet sodium, a prescription eye drop for the treatment of dry eye syndrome (keratoconjunctivitis sicca or KCS). Pending clearance by the FDA, ISTA intends to initiate the Phase IIb trial in the second quarter of 2005.

Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA stated, "The ecabet sodium IND filing represents the accomplishment of a key objective for 2005, and we are looking forward to advancing this product through the clinic. We believe that ecabet sodium has a strong safety profile, and one of its advantages, the ability to stimulate mucin secretion and thereby improve the overall quality of tears, may provide the efficacy needed for approval of this type of drug."

ISTA's ecabet sodium Phase IIb trial is designed to evaluate several ocular signs and symptoms, the results of which will be used to define the efficacy endpoints for the Phase III trial.

Ocular signs that will be evaluated during the Phase IIb trial include but are not limited to corneal and conjunctival staining and tear film break-up time.

Ocular symptoms that will be evaluated during the Phase IIb trial include but are not limited to burning or stinging, itchiness or scratchiness, grittiness or sandiness, foreign body sensation, haziness or blurriness.

Generally, improvement in one sign and one symptom are considered acceptable by the FDA for approval of a prescription dry eye product.

ISTA acquired U.S. rights to ecabet sodium for the treatment of dry eye syndrome from Senju Pharmaceuticals Co., Ltd. in November of 2004. Senju's ecabet sodium eye drop product is currently in Phase II testing in Japan for the treatment of dry eye syndrome and is already marketed in Japan as an oral agent for gastric ulcers and gastritis.

Ecabet sodium represents a new class of molecules that increase the quantity and quality of mucin produced by conjunctival goblet cells and corneal epithelia. Mucin is a glycoprotein component of tear film that lubricates while retarding moisture loss from tear evaporation.

Based on data compiled from various publicly available sources, ISTA estimates that sales in the U.S. prescription dry eye market were approximately $95 million in 2004 and are anticipated to grow to approximately $350 to $700 million in annual sales within three to five years.

[Erik]

BTW: Iceboat does sound better, Diana. Also, diquafosol has not been rejected by the FDA (not yet, anyway)--see my other post.