FDA Panel backs Ocriplasmin
Enlarge image


FDA Panel backs Ocriplasmin

30.07.2012 - Nail-biter with Happy End: An expert panel of the FDA has backed Belgian Thrombogenics eye disease drug Ocriplasmin.

FDA advisors ruled on July 26 that Ocriplasmin helped enough people in clinical trials to warrant a favourable review. The injectable drug is a truncated form of the human serine protease plasmin which retains its enzymatic properties. It’s used for the treatment of symptomatic vitreomacular adhesion, which occurs when vitreous gel detaches at the back of the eye but adheres to the retina as it pulls away, distorting vision and causing small breaks to develop in the macula.

The panel decided in an 6-3 split decision, that  there is no need for additional studies despite evidence of adverse effects including eye pain, swelling and impaired vision. Nevertheless, Michael Repka, Chairman of the panel said, that post-market studies on this topic „would be nice“, reported Bloomberg.

A regulatory review published a day before the panel’s decision has sent the drugmaker’s stock price rollercoasting. A warning on serious adverse events in the report sent down the quotation by 19% at NYSE Euronext in Brussels. The Belgian Biotech Company tried to pour oil on troubled waters. "We have evidence that these things are all transient. There is nothing that is really sustained. Of course, we will address this during the discussion," ThromboGenics CFO Chris Buyse told Reuters. On July 27, the first day after the panel’s favourable decision, stock quotes raised by 13% to 26.37 Euro.

ThromboGenics, based in Heverlee, has already sold rights to the drug outside the U.S. to Swiss drugmaker Novartis AG. Its Alcon unit paid $99m upfront and promised close to $400m more in milestones to gain the rights to commercialise the drug.


01.12.2015 Almirall is strengthening its dermatology focus with the takeover of Poli Group. Part of the deal are the group’s two pharma companies, German Taurus Pharma GmbH and Swiss Polichem S.A., and Italian Polichem S.r.l., which produces plastics additives.


26.11.2015 Bioeconomy movers and shakers from every corner of the globe met this week at the world’s first Global Bioeconomy Summit in Berlin to discuss, debate and define better ways to ensure the bioeconomy succeeds on an international level.


24.11.2015 After weeks of speculation it is official: US pharma major Pfizer and Irish Botox maker Allergan will merge. With the deal, Pfizer is planning to dodge the high US taxes, causing indignation among US politicians.


23.11.2015 Amidst talk of the IPO window closing and cancelled flotations, diagnostics firms are still striking a chord with investors. Swedish Immunovia and German Curetis are successfully raising public money.


20.11.2015 French Sanofi and British AstraZeneca are giving open innovation a go: The two pharma giants will exchange thousands of compounds – for free.


19.11.2015 French gene editing company Cellectis has granted Servier the rights to bring cancer immunotherapy UCART19 to market. Servier in turn has teamed up with Pfizer to hurry development along.


17.11.2015 The first Italian accelerator specifically for biotech projects has been launched with help from Sofinnova Partners. The plan of BiovelocITA: to help Italy grow into one of Europe’s strongest biotech markets.


13.11.2015 Scientists in Bath, UK, have developed a medical dressing that turns fluorescent green when it detects infection. The researchers hope that the smart burns dressing will help fight antibiotic resistance.


13.11.2015 Out with the old: Roche is discarding four sites with 1,200 staff in an effort to restructure its manufacturing network for small molecules. Instead, a new manufacturing site will be built in Switzerland.


10.11.2015 Algae have many skills, but cancer fighting was not one of them – until now. Researchers from Australia and Germany have genetically engineered diatom algae to accurately deliver chemotherapeutic drugs.


All Events

Current issue

All issues

Product of the week


Stock list

All quotes


  • BIOFRONTERA (D)1.99 EUR6.99%
  • EPIGENOMICS (D)2.80 EUR5.66%


  • THERAMETRICS (CH)0.04 CHF-20.00%
  • EVOCUTIS (UK)0.11 GBP-8.33%
  • SARTORIUS (D)246.25 EUR-7.08%


  • PLETHORA (UK)5.50 GBP100.0%
  • GENMAB (DK)910.00 DKK33.8%


  • EPIGENOMICS (D)2.80 EUR-43.4%
  • EVOCUTIS (UK)0.11 GBP-26.7%


  • KARO BIO (S)37.60 SEK5349.3%
  • CHRONTECH PHARMA (S)0.34 SEK1600.0%
  • GALAPAGOS (B)47.21 EUR263.2%


  • BIOTEST (D)15.71 EUR-80.7%
  • NEOVACS (F)0.78 EUR-76.6%

No liability assumed, Date: 01.12.2015