MIM-D3 is the first in a class of molecules called TrkA agonists. MIM-D3 stimulates the production of mucin, which plays a critical role in the protection and overall health of the ocular surface. Mucins are essential for lubrication; the removal of allergen, pathogens, and debris; and corneal epithelial healing to reduce ocular surface damage. In addition, MIM-D3 may have additional benefits than currently available dry eye therapies, including the potential to improve neural function, which may improve corneal sensitivity and integrity.
The pivotal trial will further evaluate the safety and efficacy of MIM-D3 in the treatment of dry eye syndrome. Approximately 400 patients will be randomized to receive 1% MIM-D3 ophthalmic solution or placebo twice daily over an 8 week period. The primary endpoints of the study are corneal fluorescein staining score in the CAESM and ocular dryness. The safety and comfort of MIM-D3 compared to placebo will also be evaluated.
"It is very exciting to see MIM-D3 entering Phase 3 clinical trials for dry eye," says
"This pivotal Phase 3 study aims to build upon the positive results observed in the Phase 2 dry eye trial, which demonstrated significant improvements in both signs and symptoms after 14 and 28 days of dosing," said
“We look forward to confirming the therapeutic potential of MIM-D3 which targets an underlying cause of dry eye through a novel mechanism,” said
Bausch + Lomb, the global eye health company, and
About Dry Eye Syndrome
Dry eye occurs when the eye does not produce enough tears, or when the tears are not of the correct consistency and evaporate too quickly. Inflammation of the surface of the eye may also occur. If left untreated, the condition can lead to pain, ulcers, or scars on the cornea, and some loss of vision, although permanent loss of vision from dry eye is uncommon. Dry eye can also have a significant impact on quality of life, making it more difficult to perform activities such as using a computer or reading for an extended period of time.
About Bausch + Lomb
Bausch + Lomb, a Valeant Pharmaceuticals International, Inc. company, is a leading global eye health company that is solely focused on protecting, enhancing, and restoring people’s eyesight. The core businesses include ophthalmic pharmaceuticals, contact lenses and lens care products, and ophthalmic surgical devices and instruments. Founded in 1853, we globally develop, manufacture and market one of the most comprehensive product portfolios in our industry, which are available in more than 100 countries.
Ora is the world’s leading independent, full-service ophthalmic CRO and product development firm. Over the past 30 years, we helped our clients earn 34
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