Originally Published EMDM March/April 2002
INDUSTRY NEWS
Contract Firm Aids Development of Ocular Drug-Delivery Device |
| The Eyegate delivers drugs to the posterior of the eye via iontophoresis. |
A Dutch injection moulding and contract manufacturing firm recently played an active role in the development of an ocular drug-delivery device. The innovative Eyegate product, created and patented by Optis France S.A. (Paris), delivers drugs into the posterior of the eye without the use of a needle. Medisize (Hillegom, Netherlands) designed the product's injection moulds and performed both hard- and soft-material selection and testing. The company also worked with Optis to develop the product's blister packaging and to plan its EtO sterilization validation.
The Eyegate, which operates on the principle of iontophoresis, consists of two parts: a reusable generator and a disposable applicator. The applicator contains an inner ring that holds the drug agent, and a conductive ring through which electric current is run to deliver constant amounts of the drug to the eye, particularly the choroid and the retina.
The applicator—along with its associated tubes and syringe, which are used to inject the drug into the unit —is sterile, disposable, and sealed in a blister package. After six years of research, preclinical tests, and refinements, Optis has obtained the CE mark for the device and is ready to commercialize it.
"We also develop our own products, so we know the medical market," says Annemarie Willems, account manager at Medisize, noting that the firm was able to recommend a change in the product's shape to facilitate sterilization by EtO. Medisize offers clients product development support and uses 3-D CAD systems for renderings and simulations of moulding processes.
Pierre Roy, technical director at Optis, explains the company's decision to partner with Medisize for the project. "We needed an OEM supplier that had experience in overmoulding and was equipped with the latest technology in that field," he says. Roy adds that Medisize's use of modern CAD systems made it an attractive partner. "We are working in a dynamic field of a new medical technology, which meant that the project had to be updated frequently, preferably on-line," he says. "We also needed an integrated OEM supplier, capable of assembly, packaging and sterilization."
According to Roy, Optis invested a good deal of time in the search for the right supplier. "We consulted several subcontractors in Europe, most of them very talented," he says, adding that among these candidates, only Medisize offered the firm assistance from the prototype phase to industrialization.
Roy explains that because the Eyegate applicator is placed directly on a very delicate surface of the eye, the very first applicators that were used for clinical trials were made out of low-Shore-hardness RTV silicone, which is heat sterilizable.
As the device approached the commercialization phase, however, the company opted for an applicator made out of two parts, one rigid enough to hold a wire electrode, and one soft enough to contact the eye. "The device also needed to be transparent to ease the precise positioning and centring of the circular [component] around the cornea and to be able to check for the presence of air bubbles that are generated by the iontophoresis process," says Roy.
Silicone was considered for the job, Roy says, but it was eventually ruled out because of its cost of manufacture and incompatibility with other materials. Optis finally settled on a tailored SEBS-based compound, suitable for overmoulding on a PS-type material.
"Here, the challenge was to mould a soft material over a rigid material," explains Roy, adding that Medisize's core technology of overmoulding was particularly suitable for the project. The last challenge was in the mould design, where Optis required a perfect distal finish of the part that comes into contact with the eye, free of weld lines, cuts, or scars.
Although Optis's core business is ocular drug delivery, the firm is currently performing preclinical tests for two new devices in other fields, one involving catheters and the other involving transdermal patch technology. For more information, contact Optis France S.A., 52 rue du Théatre, 75015 Paris, France; phone: +33 1 47574685; fax: +33 1 40890922; e-mail: pierre.roy@optisgroup.com; Internet: www.optisgroup.com.
Medisize produces custom-made devices for clients in the medical and pharmaceutical industry. The company focusses on value-added products manufactured using injection moulding techniques. For more information on the firm, contact Medisize B.V., P.O. Box 366, NL-2180 AJ Hillegom, Netherlands; phone: +31 252 576888; fax: +31 252 519825; e-mail: info@medisize.nl; Internet: www.medisize.com.
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