Shares in ThromboGenics have soared after regulators in the USA recommended approval for the Belgian firm's eye drug ocriplasmin.
The US Food and Drug Administration's Dermatologic and Ophthalmic Drugs Advisory Committee has backed ocriplasmin for the treatment of symptomatic vitreomacular adhesion (VMA). The panel voted 10 to 0 that the benefits of administering ocriplasmin for the treatment of vitreomacular adhesions outweigh the potential risks and the FDA is scheduled to give its verdict by October 17.
Symptomatic VMA can lead to retinal distortion, further deterioration in vision and has the potential to cause irreversible damage and complications. ThromboGenics believes that there are 500,000 patients in the USA and the major European markets and if approved, ocriplasmin will be the first pharmacological treatment for the condition.
The FDA panel also voted 6-3 that additional studies aren not required to evaluate the safety of the effect of ocriplasmin on the retina before approval, noting that treatment is a better option than surgery.
ThromboGenics, which also hopes to get approval in Europe before the end of 2012, licensed the non-US rights to Novartis' Alcon unit in March and pocketed an upfront fee of 75 million euros, plus 90 million euros in near-term payments. Additional milestones bring the potential total value of the deal to 375 million euros, plus royalties.
ThromboGenics shares jumped 13.2% to 26.37 euros and most analysts believe the Leuven-based company could have a blockbuster on its hands.