Some more thoughts on EyeBio while we wait for OPT to execute on...

Some more thoughts on EyeBio while we wait for OPT to execute on partnering/refinancing…

On June 14, 2023, EyeBio started dosing the first participants in its P1b/2 AMARONE trial with treatment naïve DME as well as treatment naïve wAMD patients. Plan was to enroll up to 92 patients for a 12-week regimen.

On February 13, 2024, Eyebio reported final week 12 data for 31 patients only. Apparently, EyeBio had taken the decision to cut the trial short and to close enrollment at 1/3 of the number of patients originally targeted:
- 26 treatment naïve DME patients receiving Restoret monotherapy.
- 5 treatment naïve wAMD patients receiving Restoret in combination with aflibercept.

So putting the numbers together - 35 weeks from June 14, 2023 to February 13, 2024 - it took EyeBio:
- maybe some 20 weeks to enroll 26 patients in DME and and a mere 5 patients in wAMD,
- 12 weeks for the treatment cycle and
- last but not least the remaining 3 weeks to clean, analyse and publish the data.

While the DME result look strong and fairly robust with 26 participants and +11.2 letters as a monotherapy, the results in wAMD have to take into account the roughly 8-9 letters of „standard improvement“ by aflibercept in treatment naïve wAMD patients. So, if the „similar to DME‘s 11.2 letters“ improvement in wAMD hovers around 11 letters, the addition of Restoret might have caused another 2-3 letters to aflibercept monotherapy.

Nothing that would reshape the world. Particularly not with a database consisting of 5 patients only.

Regarding wAMD, the timeline of EyeBio/MRK and Restoret could eventually look kind of:

P2b/3:
Dosing starting Q4 2024
Fully enrolled Q3 2025 (= 9 months for enrollment)
Primary completion date Q1 2026 (= 6 months regimen)
Topline data Q2 2026

P3:
Dosing starting Q4 2026
Fully enrolled Q2 2028 (= 18 months for enrollment)
Primary completion date Q2 2029 (= 12 months regimen)
Topline data Q3 2029

So roughly 4 years behind sozinibercept when it comes to wAMD.