FAQ

What is a clinical study?

A clinical study (e.g. LUGANO) involves research that is intended to add to medical knowledge related to the treatment of diseases or conditions (e.g. wAMD).

What is a study drug?

A study (or investigational) drug is a substance that is being tested in clinical studies and has not been approved by regulatory agencies, such as the United States (US) Food and Drug Administration (FDA), European Medicines Agency (EMA), or others.

Why is the LUGANO study important?

Wet age-related macular degeneration (wAMD) is a leading cause of vision loss in individuals age 50 years or older. This study explores an investigational drug named EYP-1901 that is designed to potentially block the proteins that cause wAMD. Pharmaceutical companies use clinical research studies like this one to learn more about investigational drugs (also called study drugs) before they are made available to the public. Study volunteers can help us in this important research. Thank you for considering participation in the LUGANO study.

What is the purpose of this study?

The main goal of this study is to learn how well the study drug (EYP-1901) works compared to aflibercept (also known as EYLEA®, an approved treatment for individuals with wAMD).

Who can participate in the LUGANO study?

This study is enrolling participants who: • Are at least 50 years of age or older • Have been diagnosed with wAMD • Have or have not received previous eye injection treatments for wAMD This is not a complete list of study requirements. The study doctor will review the full requirements with you.

How long will this study last?

You will be in this study for approximately 99 weeks (about 2 years), and you will need to come to the study center at least 26 times over this period.

What can I expect if I decide to participate?

If the study doctor decides that you meet all the requirements to be in this study, you will be randomly assigned (like flipping a coin) to receive EYP-1901 or aflibercept. You will have a 50% (1 in 2) chance of being placed in the EYP-1901 group and a 50% (1 in 2) chance of being placed in the aflibercept group. You, the study doctor, and most other people involved in the study will not be told which group you are in. However, this information will be given to the study doctor if, at any point during the study, it becomes necessary for your safety. EYP-1901 (study drug) and aflibercept will be administered and re-administered via intravitreal (IVT) injection into the designated study eye at specified visits. Before the injections, you will receive a local anesthetic to numb your eye. Eye examinations and imaging, laboratory tests and other assessments will be conducted as part of the LUGANO study. Participants will be informed of all examinations, lab tests and other assessments required prior to signing informed consent and during each study visit.

What are the costs to take part in this study?

You do not have to pay for the study drug, EYLEA® (aflibercept), study supplies, or tests that are part of the LUGANO study. You will be reimbursed for your time after each completed study center visit. You may also be reimbursed for travel expenses. If using an approved travel vendor, you will be provided with transportation should you or your caregiver need this support to get to and from study visits.

What risks are involved for study participants?

There are possible risks involved with any clinical study. Your study doctor will review the risks with you, and you will be closely monitored throughout the study.

Why should I take part in this study?

A clinical study provides the basis for the development of new drugs. The results of these studies can make a difference in the care of future individuals by providing information about the benefits and risks of therapeutic drugs. Current treatments for diseases are only available because of research study volunteers like you.