Diabetic macular edema (“DME”) is a complication of diabetes that involves edema of the central retina leading to loss of sight. DME is the most common cause of vision loss in diabetes, which again is the most common cause of blindness in working age people in many western countries. About 7% of 350 million diabetic patients in the world have DME and 25% develop DME if they have diabetes for over 20 years. DME is a major sight threatening disease around the world, especially in developed and newly developed countries and rapidly increasing with the global diabetes epidemic.
Currently available treatments for DME include monthly intraocular injections of anti-VEGF drugs, injected/implanted steroids and laser treatments. The laser treatment does not improve vision sufficiently. The anti-VEGF drugs provide overall good results for about one third of patients and the injected steroids for about one fourth of patients. Therefore, there is no treatment currently available that provides acceptable results for the majority of patients.
Oculis’ most advanced product candidate is dexamethasone cyclodextrin nanoparticle eye drops, DexNP, in two indications; diabetic macular edema (DME) and posterior/intermediate uveitis. By introducing DexNP for DME to the market, Oculis intends to add to the current treatment alternatives a noninvasive eye drop that is easier and less expensive to administer than available invasive options.
Furthermore, it is widely believed that a majority of DME patients is not currently receiving any treatment. Therefore, DexNP can be a good addition to the available treatment alternatives as well as addressing the large number of untreated DME patients.
Oculis has already completed two phase II studies demonstrating the efficacy of DexNP for DME.