dm+d

Unassigned

New Medicines

AkantiorAcanthamoeba keratitis in patients aged 13 years and older

Information

Akantior
New molecular entity
SIFI
SIFI

Development and Regulatory status

Phase III Clinical Trials
Pre-registration (Filed)
None
Yes
Yes
Jun 22Filed in EU via centralised procedure [9].
Feb 22SIFI plan to submit a MAA to EMA Q2 22, and report EMA approval of Akantior as trade name for polihexanide eye drops. A Type B meeting with the FDA is planned for April 22 [8].
Oct 21Following positive PIII trial results, the company has also confirmed plans to start on the regulatory pathway in the US [7].
Oct 21A submission to the EMA is planned for H1 22 for accelerated assessment under the Centralised Procedure for Orphan-Designated Medicinal Products [6,7].
Nov 20Also has orphan drug status in the US [5].
Jun 18Has orphan drug status in EU [3].

Category

Disinfectant that is active against bacteria and acanthamoeba
Acanthamoeba keratitis is a form of keratitis with a fairly low prevalence (7 cases per 1,000,000 in Europe), but that can have devastating effects on patients, as it can cause intense pain and, if not effectively treated, can lead to major deterioration of vision (even blindness) and corneal perforation [1].
Acanthamoeba keratitis in patients aged 13 years and older
Topical

Trial or other data

Oct 21SIFI announce PIII study meets primary endpoint of clinical resolution over 12 months [6].
Nov 20PIII trial (EudraCT2016-001823-30; NCT03274895; P134-2017) has completed enrolment (n=135) and topline results are expected in H2 2021 [5].
Jan 20PIII trial (EudraCT2016-001823-30) is ongoing in the UK and Poland [4].
Jun 17PIII trial to assess the efficacy, safety and tolerability of 0.08% polyhexamethylene biguanide ophthalmic solution, as compared with a combination of 0.02% polyhexamethylene biguanide ophthalmic solution and 0.1% propamidine combination therapy in patients affected by acanthamoeba keratitis starts (NCT03274895). 130 adolescents and adult patients in the UK &Italy. Primary outcome is clinical resolution rate at 12 months. Collection of these data is due to complete Dec 18 [2].