Novartis eye drug prevails in PhIII trials ahead of FDA action

ThromboGenics touted positive results from two Phase III trials of the Belgian biotech's experimental drug for age-related eye ailments. Published in the prestigious New England Journal of Medicine, the pair of studies shed light on data that U.S. and European regulators are reviewing to decide whether to give the developer and partner Novartis ($NVS) approvals for the therapy.

Novartis' Alcon unit forked over an initial sum of 75 million euros to ThromboGenics in March for rights to the investigational treatment, ocriplasmin, for markets outside the U.S., providing the group within the Swiss drug giant a potential new product to limit the damage of generics competition. Alcon has promised up to 300 million euros in additional payments depending on certain milestones as well as royalties on potential drug sales.

Its bet seemed justified with results from the two late-stage studies, which showed that 26.5% of patients who got the injected treatment had their vitreomacular adhesion (VMA) resolved compared with 10.1% in patients on placebo. And ThromboGenics, which sponsored the two studies with 652 total patient, reports that 40.6% of patients treated with its drug saw closure of macular holes compared with 10.6% of placebo patients. Ocriplasmin was linked with more side effects, but the company noted that most were temporary.

Ocriplasmin offers the first potential drug against VMA, which is now treated with hit-or-miss surgery. As The Wall Street Journal reported, VMA happens when the jelly-like material in the center of the eye sticks too strongly to the retina and leads to vision problems. Seeing the potential of the drug to treat multiple eye ailments, ThromboGenics estimates that half a million patients in the U.S. and key EU markets could benefit from the drug.

FDA advisers gave their non-binding endorsement of the drug for VMA last month, despite safety concerns raised by agency staff. And ThromboGenics, which controls marketing rights to the drug in the U.S., expects to learn the agency's decision on approval by Oct. 17.

- here's the release
- check out the WSJ article
- and the story in the Philadelphia Inquirer

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