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ThromboGenics Receives Positive CHMP Opinion For JETREA®

Stocks in this article: THR

JETREA ® works by separating the vitreous humour from the macula, and helping to close the macular hole if one is present which may decrease the symptoms caused by VMT.

Currently the only available treatment in the EU is "observation" or "watchful waiting" until a patient becomes a surgical candidate, usually at a very late stage of the disease. [ 2 ] , [ 3 ] A patient would then receive a surgical procedure and repair of the retina. However, for many patients this is not a suitable option, as irreversible damage to the retina may have already occurred. [ 4 ] , [ 5 ]

" Vitreomacular traction and macular hole formation are disabling eye diseases that influence visual function, and affect activities of patients in their daily life, " said Prof. Dr. Peter Stalmans, Department of Ophthalmology,  University  Hospitals ,  Leuven ,  Belgium .  " When the disease worsens, vitrectomy surgery is the only available treatment option. Release of the vitreous traction by pharmacologic vitreolysis can omit the need for vitrectomy. Upon approval, JETREA ® will be the first available product with proven clinical efficacy to release vitreous trac tion, hence provides a paradigm- shifting treatment option for these eye diseases, " he concludes.

Dr. Albert Augustin, Professor of Ophthalmology and Chairman of the Department of Ophthalmology at the  Klinikum  Karlsruhe, Germany , said:  " JETREA ® represents an important breakthrough for both physicians and patients and  is expected to establish a new standard of care for patients with VMT and small macular holes. If approved, a single injection of JETREA ® in the affected eye could help to prevent disease progression and/or vision loss. "

For patients with VMT and macular holes, everyday activities, such as reading, driving, the ability to work, use computer screens and overall quality of life are significantly affected," said  Professor Yit Yang, Consultant Ophthalmologist, Wolverhampton Eye Hospital, and Visiting Professor, Aston University, UK.    "I am looking forward to administering JETREA ® to patients who I would normally observe till worsening or progression of the disease, as we seek to improve their quality of life. "

The EU MAA submission was based on data from two pivotal Phase III clinical trials that evaluated the safety and efficacy of a single administration of JETREA ®. Both studies met their primary endpoint and demonstrated that JETREA ® successfully resolved VMT and macular holes compared to placebo.

At day 28, 26.5% Jetrea-treated patients achieved resolution (versus 10.1% with placebo [P<0.001]). 72% of JETREA ® patients who achieved resolution of VMT and macular holes by Day 28, did so within seven days. [ 6 ]

All adverse reactions were ocular. The most commonly reported were vitreous floaters, eye pain and photopsia, as well as conjunctival haemorrhage resulting from the injection procedure. Most of the adverse reactions occurred within the first week after the injection. The majority of these reactions were non-serious, mild in intensity and resolved within 2 to 3 weeks. [ 6 ]

References

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