Allotex kondigt begin van de laatste fase van presbyopie klinische onderzoeken aan
BOSTON- (BUSINESS WIRE) – Allotex, een in Boston gevestigd privaat bedrijf dat de TransForm Cornea Allograft (TCA) ontwikkelt voor de behandeling van presbyopie (voor leesbrillen) en verziendheid, is bijzonder verheugd te kunnen melden dat meer dan vijftig ogen zijn behandeld in de eerste fase van de klinische proeven.
De TCA is gemaakt met behulp van natuurlijk menselijk hoornvliesweefsel dat is gevormd met behulp van gepatenteerde en speciale technologie van hoge precisie. Deze gevormde lenzen worden in het natuurlijke hoornvlies van de patiënt geplaatst met als doel het verminderen of elimineren van de noodzaak van een bril.
Allotex Announces Commencement of Final Phase of Presbyopia Clinical Trials
BOSTON–(BUSINESS WIRE)– Allotex, a Boston based private company developing the TransForm Corneal Allograft (TCA) for the treatment of presbyopia (reading glasses) and hyperopia (far sightedness), is pleased to report that over 50 eyes have been treated in the first phase of its clinical trials.
The TCA is created using natural human corneal tissue that has been shaped using high precision patented and proprietary technology. These shaped lenticules are placed in the patient’s natural cornea with the aim of reducing or eliminating the need for spectacles.
Dr. Arthur Cummings of the Wellington Eye Center in Dublin commented on his experience with the TCA for presbyopia: “My impression of TCA inlays is very positive on a number of fronts. The patient acceptance has been better than with any other inlay that I have used before, the patient satisfaction is very high, and every time I look at the pristine cornea and find it difficult to even see the inlay, I am reassured about the bio-compatibility.”
From Medipol University, Professor Aiylin Kilic notes that she has seen positive results using the allogenic TCA in treating patients with presbyopia, hyperopia, and hyperopic presbyopia, and patients with regression after hyperopic LASIK treatment. “I feel very comfortable when I recommend the TCA for refractive treatment because the most important advantages of allogenic corneal inlays are safety and reversibility. The use of allogenic tissue provides biocompatibility and very good integration into the cornea, which is not possible with a synthetic inlay.”
Allotex CEO, Dr. David Muller states: “We are very pleased with the progress and the results of our initial clinical trial. Patient satisfaction has been high, surgeons are comfortable with the procedure, and we are excited about moving into the final phase of the European clinical trials. We expect to be able to fully commercialize our TransForm products in Europe within the next 12 months.”
Joining Drs. Cummings and Kilic in the final phase of the clinical trials are:
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- Belgium: Dr. Erik Mertens (www.medipolis.be)
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- UK: Mr. Sheraz Daya (www.centreforsight.com), and Mr. Samer Hamada (www.eyecliniclondon.com)
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- Slovakia: Dr. Pavel Stodulka (www.lasik.cz)
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- France: Professor Francois Malecaze (www.chu-toulouse.fr)
About the Wellington Eye Clinic
The Wellington Eye Clinic in Ireland (www.wellingtoneyeclinic.ie) is a specialist cataract and refractive Eye Centre and was the first clinic in Europe to purchase an excimer laser. Since then, the clinic has specialized and focused on refractive outcomes for both vision correction procedures and cataract procedures. Over the last 37 years the center has performed more than 57,000 refractive procedures.
About Medipol
Istanbul Medipol University in Istanbul (www.medipol.edu.tr) has nine research hospitals as well as 13 research centers, which are organized into multiple core facilities and labs with the highest technology available, attracting many high-profile researchers from all over the world.
About Allotex
Allotex Inc. is an ophthalmic biologics and device company developing new therapeutic solutions for the treatment of presbyopia and hyperopia. The therapy is accomplished through tissue addition technology that uses precisely shaped human corneal allografts to create what is essentially a permanent, living contact lens or lens insert. Allotex is a clinical stage company led by Drs. David Muller and Michael Mrochen.
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Contacts
Anna Bullard
Info@Allotex.com
www.Allotex.com