A phase I/IIa study to evaluate the safety, pharmacokinetics and pharmacodynamics of Macuneos in healthy volunteers and then in patients suffering from dry AMD.
Phase of Trial: Phase I/II
Latest Information Update: 22 Oct 2018
At a glance
- Drugs Macuneos (Primary)
- Indications Dry age-related macular degeneration
- Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics
- Acronyms MACA-PK
- 22 Oct 2018 According to a Biophytis media release, the company intends to request scientific advice from the FDA and EMA in Q1 2019, and to obtain regulatory approvals for the MACA-PK study of safety and pharmacokinetics in healthy volunteers in S1 2019.
- 26 Jul 2018 According to a Biophytis media release, the MAD portion of the study will be conducted in Europe. The study will commence in 2018 and is expected to complete in 2019.
- 28 Mar 2018 According to a Biophytis media release, the regulatory approval process is underway and the Single Ascending Dose (SAD) phase of the study could begin this summer. The results of the SAD phase are expected before the end of the year.