First patients enrolled in dry eye device study

Patient recruitment has started in a randomised clinical trial testing an experimental device (Lamelleye, known also as CXB/1-14) for the treatment of dry eye disease (DED).

A total of 30 patients will be enrolled at Glasgow Caledonian University’s Vision Sciences clinic, in Glasgow, UK, according to a press release from the company behind the device, Lamellar Biomedical, which is also based in Glasgow.

The firm expects to report results in the second half of 2017, as well as attract a licensing partner to help it bring the product to the European market in 2018.

“We believe that Lamelleye has the potential to be an important advance in the treatment of DED,” Lamellar CEO Dr Alec McLean said.

The product is designed to replace ocular lipid layer phospholipids, which are generated by the lacrimal gland and meibomian glands in the eyelids and are produced in insufficient quantities in DED.

When these lipids are lacking, the aqueous layer evaporates, causing symptoms of burning and grit-like feelings in the eye. Long-term dry eye can lead to damage to the cornea, including scarring that can interfere with vision.

Lamellasomes

Lamelleye utilises a technique the company calls Lamellasomes, developed to mimic human serous lamellar bodies, which regulate the internal interfaces between multiple human tissues as well between tissues and the external environment.

In addition to testing it in dry eye, Lamellar Biomedical is assessing this technology in radiotherapy-induced xerostomia and cystic fibrosis. The treatments under development “act biophysically, are muco-restorative and have the potential to resolve a broad range of disease states that are associated with dry or sticky mucosal surfaces and topical infection,” the company said.

According to a description of the device’s trial on the clinicaltrials.gov website, Lamelleye consists of a liposomal multi-dose preservative-free sterile saline suspension containing soy lecithin phospholipids, sphingomyelin and cholesterol. The product is “surface active, mucokinetic and lubricant,” according to the press release.

The single-blind cross-over trial will compare the technology head-to-head with eye drops (Optive Plus, Allergan). The multi-dose sterile solution contains sodium carboxymethylcellulose, glycerine, castor oil, polysorbate 80, levocarnitine and erythritol, preserved with Purite, which breaks down into natural tear components in the eye.

Many products use preservatives and additives to prolong shelf life, the press release notes. But these are potential eye irritants, especially in patients with dry eye, it said.

By contrast, “Lamelleye has been developed without preservatives and additives to avoid the potential risks associated with these ingredients whilst also being delivered from a convenient multi-dose preservative free eye dropper, avoiding the inconvenience of carrying multiple single-use preservative free packs,” according to the press release.

Patients with confirmed mild-to-moderate dry eye will be treated for 2 weeks with either Lamelleye or Optive Plus before undergoing a 1 week washout and crossing over to the alternative treatment for a further 2 weeks.

Outcome measures include: non-invasive tear breakup time; symptom scores (ocular surface disease index and visual analogue scale); rate of tear film evaporation (evaporimetry); tear film osmolarity; effect on the structure and quality of the tear film (interferometry); and effect on the integrity of the anterior surface of the eye (corneal and conjunctival staining).

“We anticipate that this new study will provide conclusive evidence of the clinical benefits that Lamelleye can deliver and demonstrate its superiority over an existing product for the relief of dry eye disease,” Dr McLean said in the press release.

Lamelleye received a CE mark as a medical device in 2015.

In May, Lamellar Biomedical announced that it had concluded a £5.75 million fundraising led by Invesco and supported by the Scottish Investment Bank.