Niche began discussing Nanomerics’ clinical ambitions in 2016, with the company’s clinical strategy coming into focus in early 2021. Niche was invited to provide support for the development of the regulatory documentation for OC134, a reformulation of tacrolimus targeting severe atopic keratoconjunctivitis and vernal keratoconjunctivitis. The Niche team’s expertise in the preparation of IBs and its previous experience with tacrolimus meant that it quickly and efficiently developed the necessary regulatory submission documentation. The Investigator’s Brochure and Investigational Medicinal Product Dossier were based on information from the scientific literature and incorporated Nanomerics’ pre-clinical experimental data.

Niche became a crucial component in the clinical trial planning team, taking part in regular mapping and strategy meetings as the submission deadline approached. Niche team members worked closely with both Nanomerics and the study physician, based at Moorfields Hospital, to develop a robust clinical study protocol to examine the safety and tolerability of OC134 in human volunteers. This is called Sunlight Trial and is the first of Nanomerics’ planned clinical projects.

Niche also supported the Nanomerics team in the development of the ILAP submission, conduct of the ILAP meeting and development of the TDP for OC134.