LEUVEN, Belgium, August 22, 2011 /PRNewswire/ --
New data presented by leading retinal specialists Dr Pravin U. Dugel, MD (Phoenix, AZ) and Dr Peter K. Kaiser, MD (Cleveland, OH)
ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on developing innovative ophthalmic medicines, announces that new data, including six month outcomes, from its pivotal ocriplasmin Phase III clinical program were presented at the 2011 ASRS Annual Meeting in Boston, USA (20-24 August 2011).
The ASRS is the largest vitreoretinal specialty society in the world, with more than 2,400 members from 55 countries. Its annual meeting represents one of the largest gatherings in the U.S. of retinal specialists, with over 850 ASRS delegates attending the 2011 meeting.
Ocriplasmin is a novel pharmacological agent being investigated for the treatment of symptomatic vitreomacular adhesion (VMA) including macular holes. Symptomatic VMA is a condition when the vitreous gel adheres in an abnormally strong manner to the retina. VMA can lead to loss or distortion of visual acuity. Market research conducted by ThromboGenics suggests that there are approximately 500,000 patients in the U.S. and major markets of the EU who would benefit from ocriplasmin if it were approved for symptomatic VMA including macular holes.
In 2010, ocriplasmin successfully completed two pivotal Phase III trials (TG-MV-006 and TG-MV-007) involving a total of 652 patients in Europe and the U.S. Both Phase III trials met the primary endpoint of non-surgical resolution of focal vitreomacular adhesion one month after a single injection of ocriplasmin.
Dr Dugel presented "Ocriplasmin for the Treatment of Vitreomacular Traction Syndrome: Phase III Results." Key highlights included:
- New data confirming earlier Phase III results that a single injection of ocriplasmin resolved VMA and the visual symptoms associated with it in 29.8% of VMT patients, compared with 7.7% of patients on placebo (28 days), a highly statistically significant result (p=0.001)
- 10.1% of patients in the ocriplasmin arm gained three lines in visual acuity compared with 5.1% on placebo (6 month follow up)
- Ocriplasmin was associated with a lower incidence of retinal tears or detachments, seen in just 1.7% of patients, compared with 4.3% on placebo (6 months)
Dr Kaiser presented six-month follow-up data on "Ocriplasmin for the Treatment ofMacular Hole: Phase III Results." The main points included:
- Approximately 40.6% of patients with full thickness macular hole (FTMH) achieved closure compared with 17% on placebo (p=0.004)
- Approximately 58% of patients with FTMHs smaller than 250 μm saw closure with ocriplasmin compared with just 20% in placebo patients
- 27% of patients gained ≥ 3 lines in visual acuity after six months of treatment with ocriplasmin, compared with 13% on placebo
Dr Peter Kaiser, Professor of Ophthalmology at the Cleveland Clinic, Lerner College of Medicine commenting on today's announcement, said: "The new data presented today confirms the effectiveness of ocriplasmin in patients with VMA.This is important given that symptomatic VMA is implicated in a range of retinal disorders which impair vision. I am confident that ocriplasmin will provide an effective and safe pharmacologic option which can be used to treat patients earlier."
Patrik de Haes, CEO of ThromboGenics, added: "The growing interest in ocriplasmin among the international retinal community reinforces our commitment to make available a drug that could significantly advance the treatment of vitreoretinal disorders. We remain on track to make regulatory filings for this novel compound in Europe and the U.S. by the year-end."
Dr Peter K. Kaiser, MD, is Professor of Ophthalmology at the Cleveland Clinic Lerner College of Medicine, and Founder and Director of the Digital Optical Coherence Tomography Reading Center. He is Study Chairman of five international clinical trials and Principal Investigator in several other trials. Dr Kaiser has authored seven textbooks, 25 book chapters, and more than 150 peer-reviewed manuscripts.
Dr Pravin U. Dugel, M.D, is Managing Partner of Retinal Consultants of Arizona and Clinical Associate Professor at the Doheny Eye Institute, Keck School of Medicine, University of Southern California in Los Angeles. He has delivered numerous named lectures internationally and has served as primary investigator in many National Eye Institute research studies Dr Dugel has authored more than 200 papers and book chapters.
ThromboGenics is a biopharmaceutical company focused on the discovery and development of innovative ophthalmic medicines. The Company's lead product ocriplasmin has completed two successful Phase III clinical trials for the pharmacological treatment of symptomatic vitreomacular adhesion (VMA). Ocriplasmin is also being evaluated in Phase II clinical development for additional vitreoretinal conditions. ThromboGenics is also developing novel antibody therapeutics in collaboration with BioInvent International; these include TB-402 (anti-Factor VIII), a long-acting anticoagulant in Phase II, and TB-403 (anti-PlGF) in Phase Ib/II for cancer in partnership with Roche.
ThromboGenics is headquartered in Leuven, Belgium. The Company is listed on NYSE Euronext Brussels under the symbol THR. More information is available at http://www.thrombogenics.com.
Important information about forward-looking statements
Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report.
For further information please contact:
Dr. Patrik De Haes, CEO
Chris Buyse, CFO
Citigate Dewe Rogerson
David Dible/ Nina Enegren/ Sita Shah
SOURCE ThromboGenics NV