BRM421 for Dry Eye Syndrome

BRIM Biotechnology is accelerating the cycle of innovation by leveraging its PDSP technology platform to bring novel ophthalmology treatments to market. Our lead asset, BRM421, is on track to become a first-in-class treatment for Dry Eye Syndrome (DES) which treats and repairs corneal damage.

About Dry Eye Syndrome

Dry Eye Syndrome (DES) is a common disorder in which the eyes produce insufficient tears to lubricate the eye. It can stem from pre-existing eye abnormalities, previous disease or medical intervention. Aside from dry eyes, the most common symptoms of moderate-to-severe DES are eye fatigue, headaches, neck/shoulder pain, and blurred vision. In some cases, patients experience other symptoms including redness, burning sensations or constant pressure on the eye. DES is increasing globally with an estimated 1.52 billion cases worldwide in 2020*. There is currently no cure for Dry Eye Syndrome, and there is a lack of effective  therapies available to patients.

Developing Novel Treatments for Dry Eye Syndrome

BRM421 is a developing topical ophthalmic solution for patients with moderate-to-severe DES.The active pharmaceutical ingredient of BRM421 is a synthetic peptide comprised of 29 amino acids derived from Pigment Epithelium-Derived Factor (PEDF) with neurotrophic and anti-inflammation properties. PEDF is a secreted glycoprotein with numerous known biological effects, including the promotion of tissue regeneration at the ocular surface. BRIM’s PEDF-derived Short Peptide (PDSP) has been shown to promote growth and expansion of limbal epithelial stem cells in severe ocular wounds on both mice and rabbits. BRM421 has a unique mechanism of action. It stimulates proliferation and differentiation of corneal limbal stem cells, and as a result, speeds up the corneal repair process. It also promotes proliferation and differentiation of goblet cells, improving Dry Eye tear quality.

BRIM has completed two Dry Eye Syndrome clinical studies, a First-in-Human (FIH) Phase II study and a Second-in-Human (SIH) Phase II/III study. These two studies have shown BRM421 to be a safe and, effective Dry Eye Syndrome therapy, with early on-set action. BRM421 is expected to enter a Phase III study at the end of 2022 and to file an NDA in 2026.

* Statistics from Datamonitor Healthcare.