OKYO Pharma has announced plans to file an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for OK-101 to treat Dry Eye Disease (DED), in the fourth quarter (Q4) of this year.
The lipid-peptide analog, OK-101 comprises a 12 amino acid peptide sequence, an anchoring lipid domain, and a linker component.
It has been developed using a new membrane-anchored peptide (MAP) technology.
The drug candidate is intended for increasing the potency and combat ocular washout by adding the lipid ‘anchor’ that is contained in the molecule for improving the residence time in the ocular environment.
The company stated that OK-101 is being developed for the treatment of ocular diseases, including Dry Eye Disease (DED), ocular pain, allergic conjunctivitis, and uveitis.
In the first quarter of 2023, the human trial of OK-101 designed as Phase II trial is planned in DED patients.
If successful, the study will expedite the timeline to new drug application (NDA) for the drug candidate.
OKYO Pharma stated that Ambio Pharmaceuticals Group’s subsidiary AmbioPharm is supporting the OK-101 programme with peptide synthesis and development.
OKYO Pharma CEO Gary Jacob said: “We are absolutely delighted to have AmbioPharm, a global leader in the synthesis of peptides and peptide analogs, manufacturing our drug candidate OK-101.
“The work performed by Ambiopharm during this post-COVID 19 period to keep us on schedule with the manufacture of API went above and beyond the call of duty and was a testament to the high standards that AmbioPharm abides by.”