In short
MK-8748, also known as EYE201, is an investigational protein-based medicine given by injection into the eye. It is being studied in two authorised clinical trials for neovascular age-related macular degeneration (NVAMD), a condition that causes vision loss. The trials together plan to enrol 1,925 participants and compare MK-8748 against aflibercept, an existing treatment.
Key points
- MK-8748 (EYE201) is an investigational protein-based medicine injected into the eye.
- It is being studied in neovascular age-related macular degeneration (NVAMD), a cause of vision loss.
- Both trials are Phase 4 studies with a total of 1,925 planned participants.
- The main measure is change in best-corrected visual acuity (BCVA) from baseline to one year.
- MK-8748 is being compared with aflibercept, an existing treatment for NVAMD.
- Both trials are currently authorised, meaning they may begin enrolling participants.
What is MK-8748?
MK-8748, also known by the development code EYE201, is a protein-based substance that is still investigational, meaning it has no marketing authorisation in the product records reviewed here. It is supplied by Eyebiotech Limited and is classified under the therapeutic area of eye diseases. The substance is being developed as a possible treatment for neovascular age-related macular degeneration (NVAMD), a condition in which abnormal blood vessels grow under the retina and can leak fluid or blood, damaging central vision.
How does MK-8748 work?
The registry data do not describe the exact mechanism of action of MK-8748. As a protein-based substance given by injection into the eye, it belongs to a class of medicines known as intravitreal therapies, which are delivered directly into the vitreous, the clear gel that fills the eye. The trials compare MK-8748 with aflibercept, an established treatment for NVAMD that blocks a protein called vascular endothelial growth factor (VEGF), which drives the growth of abnormal blood vessels in the eye.
Which conditions is it studied for?
- Neovascular age-related macular degeneration (NVAMD) — also called wet AMD, this is an eye condition in which abnormal blood vessels grow under the macula, the part of the retina responsible for sharp central vision, leading to vision loss.
How is MK-8748 given?
MK-8748 is formulated as a solution for intravitreal injection, meaning it is injected directly into the eye. In the trial records, the route of administration is listed as \"other use\", which reflects the intravitreal route described in the study titles. The comparison medicine, aflibercept, is given at a dose of 2 mg by intravitreal use.
What do the clinical trials show?
Two clinical trials of MK-8748 are registered, both authorised and both Phase 4 studies in NVAMD. The first trial, with the EU CT number 2025-524575-22-00, plans to enrol 960 participants. The second trial, 2025-524894-17-00, plans to enrol 965 participants. Both trials are described as randomised, double-masked and multicenter, meaning participants are assigned to treatment groups by chance, neither participants nor researchers know which treatment is being given, and the studies take place at multiple sites. Both trials have a three-arm design and compare MK-8748 with aflibercept. The primary objective in both studies is to demonstrate that MK-8748 is non-inferior to aflibercept, meaning it is not worse than aflibercept by a pre-specified margin, in terms of the change in best-corrected visual acuity from baseline to one year.
Who can take part in these trials?
The trials enrol participants with neovascular age-related macular degeneration. The registry records do not list detailed inclusion or exclusion criteria such as age limits, prior treatments or specific eye measurements. Both studies are authorised, meaning they have received regulatory approval to proceed and may be recruiting or preparing to recruit participants.
What are the trials measuring?
The main outcome in both trials is the mean change in best-corrected visual acuity (BCVA) from baseline to Year 1, measured using the Early Treatment of Diabetic Retinopathy Study (ETDRS) letter score. BCVA is a standard test of how well a person can see an eye chart with the best possible glasses or contact lenses, and the ETDRS score counts how many letters the person can read correctly. The primary objective is to show that MK-8748 is non-inferior to aflibercept on this measure. The second trial also lists fluorescein as an intervention; fluorescein is a dye used in eye examinations to visualise blood vessels in the retina.
What side effects are known?
The registry records provided do not include information on side effects of MK-8748. Because the substance is investigational, its safety profile is still being evaluated in the ongoing trials.