ISTA Pharmaceuticals attempts to salvage biotech drug for vitreal haemorrhage

By Gearóid Tuohy PhD

Officials at an American bio-pharmaceutical company are attempting to salvage a drug for vitreal haemorrhage that has failed clinical trials.
As part of the salvage operation, officials at California-based ISTA Pharmaceuticals were to meet with the officials at the US Food and Drug Administration to determine the fate of Vitrase.

Those meetings followed the late March announcement that results from two Phase III studies failed to show any statistical improvement in patients using the enzyme-based therapy.

The studies also showed that Vitrase was associated with adverse reactions which included iritis, hyperemia and ocular pain in some patients.

The poor clinical results represented a severe economic blow to ISTA. According to the Tufts Centre for the Study of Drug Development, it costs an average of $802 million to bring a new drug to the market.

The market for vitreal hemorrhage treatment is very large. Each year hundreds of thousands of people in the developed world temporarily lose their sight after a vitreal haemorrhage leaks into the retina and clouds their vision.

Almost 65% of all reported cases of vitreal haemorrhage arise from proliferative diabetic retinopathy. To date, the only choices for treating vitreal haemorrhage have been to operate or to simply wait up to 18 months for the clouding to clear.

The FDA had designated Vitrase for a "fast track" approval process. Such fast track approvals are reserved for "new drugs intended for the treatment of serious or life threatening conditions with potential to address unmet clinical need."

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