Novelia®
Novelia® is a multi-dose closing tip system which avoids the need for preservatives in the drug and prevents bacterial contamination over the duration of treatment.
Discover moreOphthalmic devices
A clear vision for eye care
One of the main criticalities of self-administered eye care treatments today is poor patient adherence, especially with chronic diseases.
We strive to improve patient experience by providing safe and effective multidose eyedroppers for preservative-free solutions, used all over the world.
e-Novelia
e-Novelia is the smart ophthalmic add-on which improves an already existing way of administrating ophthalmic treatments, to improve patients' adherence.
Discover moreOur integrated combination product services
ANALYTICAL SERVICES & DESIGN VERIFICATION
Our team of experts is dedicated to ensuring the safety, efficacy, and compliance of your combination product including:
• Comprehensive analytical services and design verification
• Advanced testing methods tailored to your formulation and active ingredients
• Testing method development, administration, and reporting
• Performance and integrity verification of your device and drug product
• Adherence to global standards throughout the process
HUMAN FACTORS & USER EXPERIENCE MANAGEMENT
We provide exceptional support for combination products across diverse regulatory pathways, device types, and patient populations for global markets including:
• Human Factors program strategy and risk management
• Formative/summative testing (design validation) administration
• Human Factors Enginering documentation for regulatory submissions
• Enhances safety, usability, and overall satisfaction of your combination product.
• Aligns with FDA Human Factors Engineering guidelines and ISO 62366 standards
• Extends beyond the device to include instructions for use, packaging, and training programs to optimize user adherence and engagement
REGULATORY STRATEGY & SUBMISSION AUTHORING
We provide tailored strategies and support for all stages of the regulatory process, including:
• Development of a comprehensive regulatory strategy including premarket to post-market support
• Guidance on FDA regulations and international standards (ISO 14971, ISO 10993)
• Expert support in regional regulatory guidelines
• Assistance in authoring and compiling regulatory submissions, including: Premarket Approval (PMA), 510(k) submissions, CE marking documentation, and Notified body opinion support
• Accelerated submission processes, drawing from, our experience in over 54 markets
FAQs
Our systems are predominantly used for chronic pathologies requiring long-term daily use of eye drops, such as glaucoma, dry eye disease (DED), conjunctivitis, and allergies.
- Glaucoma is a group of eye diseases which result in damage to the optic nerve and cause vision loss, being a leading cause of global irreversible blindness. Overall, the results demonstrate that glaucoma is responsible for approximately 5.2 million cases of blindness (15% of the total burden of world blindness).
- Dry Eye Disease is a common multifactorial disease of the ocular surface with loss of homeostasis of the tear film and ocular symptoms, such as irritation, redness, discharge, and easily fatigued eyes. In epidemiological studies performed globally, the prevalence of dry eye disease (DED) ranges from 5 to 50 percent.
During Novelia®’s development phase, several user tests were conducted to ensure that patients understood how to effectively use the device.
One test revealed that some patients had difficulties seeing where the drop was coming from as it emerged from the dropper. This was because the dropper valve was transparent and thus hindered patients when targeting the eye. Consequently, the valve was changed from transparent to blue, providing an obvious contrast between the dropper tip and rest of the top.
Novelia®’s patented blue tip continues to be a key driver of patient preference for the dropper, allowing for enhanced eye targeting and patient control.
The alternative way to keep eye droppers free from contamination is by the intelligent use of technology. Rather than relying on the anti-microbial properties of preservatives to kill any bacteria that enter the bottle, the ideal approach is to prevent any entry of bacteria into the bottle in the first place.
Novelia® features a one-way valve the ensures that no contaminated liquid can be re-introduced into the container after a drop has been dispensed, completely removing the need to filter the liquid. The intake of air into the dispenser takes place via a separate venting system with a silicone membrane referred to as PureFlow® technology. Contrary to other marketed devices relying on filtration technology, our patented PureFlow® technology is a continuous barrier of homogeneous material which guarantees the integrity of the system.
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Discover moreWho we are
We design and manufacture devices that maximize treatment efficacy and partner with our customers in their device strategies, to ultimately bring high-quality and safe treatment solutions to patients.
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