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Building the future
of ophthalmology

We are on a mission to tackle some of the world's biggest health challenges, trying to find solutions where none exist. At Theialife, we seek partners who want to push back the boundaries of innovation on behalf of patients.

Patient Care

OUR COMMITMENT

Theialife advances science through the development of medicines to benefit the greatest number of ophthalmology patients effectively. We are inspired by the opportunity – and the responsibility – to develop therapies with the potential to improve health, offer hope, and even change patients' lives. They deserve a better quality of life. To provide patients with new options for healthier lives, our passion and compassion drive us to develop cutting-edge treatments that enhance sight for life.

CLINICAL TRIALS

We are Accelerating Clinical Research to Address the Unmet Needs in Ophthalmology

Theialife is committed to developing ocular disease therapies that improve treatment options for people with sight-threatening diseases. Patients and families' personal stories guide our work. We earn their trust through our company's decisions, actions and words. Explore our website and contact us for the latest updates on our programs at patientadvocacy@theialife.com

Pediatric Myopia

Phase-2 (2008)

Systemic ND10 in retarding axial eye growth and myopia progression: a 36-month pilot study

Phase-3
More details to follow.

Theialife’s Lead investigational medicinal product ND10 has been developed by Theialife’s team of dedicated scientists for the treatment of Myopia (or near-sightedness) in children. Global Phase III Clinical Trial will start soon, after competing discussions with the US FDA and other regulatory agencies.

ND10 Development timeline:

Phase I trial – DATE
Phase II trial – DATE
Real World Evidence – Since 2009, ND10 has been used in a named-patient program in Denmark, treating over 1200+ children over 14 years after the Phase-II trial was completed. ND10 has been found to be safe and effective.
The Danish Medicines Agency confirms no adverse events have been reported since 2009, since the children started taking ND10.
- Data published in a globally respected journal, viz., British Ophthalmology Journal in August 2022 - LINK
- Analysis of the results seems to suggest that it is effective in children aged 6-11 who are at significant risk of developing High Myopia.

ND10 is yet to be approved by the US FDA & EMA.

A. Participate in our clinical trials

Clinical trials provide patients with access to investigational drugs. Theialife plans to conduct global clinical trials to evaluate ND10's safety and effectiveness so that regulatory authorities - such as the US-FDA and EMA (EU).

Patients must meet the eligibility criteria in one of the participating countries to participate in a clinical trial. If you would like your child to receive access to our investigational drugs and know more about our upcoming trials, please contact trials@theialife.com.

B. Early Access Program (unlicensed medicine).

Given the long history of safety and effect proven by ND10, it is possible for your healthcare provider to know more about ND10 and access the medicine for treatment. A possible alternative is called Patient Access to Not Approved or Unlicensed Medicine. Please advise your healthcare provider to write to eap@theialife.com for more information.

“Named patient access is limited to the requested named patient or patients only, and it provides a way for individuals to access unlicensed or authorized medicines when other options are not available locally.”

Patients can determine if ND10 is available through named patient access by following these steps:

1. Consult with a Healthcare Professional

Patients should discuss their medical condition with their treating physician. The doctor can assess whether the medicine is suitable and necessary for the patient’s individual needs.

2. Check authorisation status.

If the medicine is not yet authorized in the patient’s country, the doctor can explore whether it is approved in another country. If authorized elsewhere, the patient may be eligible for named patient access.

3. Request Named Patient Access.

Only the treating physician can directly request access to the specific medicine on behalf of the patient. The treating doctor writes to Theialife on eap@theialife.com for ND10.

4. Assessment & Approval.

The company evaluates the medication's safety and efficacy for the named patient. If approved, the patient can receive the medicine under the doctor's direct supervision.

*As ND10 is not yet licensed or approved, Theialife will collect data about you after consulting with your Healthcare Provider & the child's parents/legal guardians.

THEIALIFE'S EARLY ACCESS POLICY

To transform patients' lives with ocular diseases, Theialife develops safe and effective therapies. Our goal is to successfully advance and seek marketing approval for innovative ocular cancer treatments. We also want to provide patients with broad access to our future products. We plan to initiate clinical trials on humans to assess the safety and effectiveness of our first investigational drug candidate for pediatric myopia. Early access, also known as compassionate use, allows patients to obtain investigational products without clinical trials or market approval. This is when no alternative therapies are available. In these instances, a patient’s treating physician can request an investigational product prior to regulatory approval, where allowed by local laws.

Currently open to enroll patients in the following participating countries: UK, Australia

If you are a health care provider interested in learning more about our investigational therapies, or a physician with questions about joining our early access program in the UK or Australia, please submit your request in the form below.

The company will respond to questions as soon as possible. This policy may be revised at any time by Theialife. We continue to push forward in our development programs with the goal of delivering innovative products to the largest number of patients in the shortest amount of time.

Disclaimer: The US FDA or the European Medicines Agency has not confirmed ND10 as safe and effective for its specific indications. Additionally, the investigational medical product may or may not treat the condition. Despite the absence of adverse events reported over the past 14 years, it is still possible that the product could cause unexpected or serious side effects as a result of its use. Please consult your healthcare provider.

Early Access Program