Our most advanced product candidate based on SNP technology is OCS-01, which recently completed a Phase 2 study in DME. This study is the first proof-of-concept of a topical drug effect on a chronic retinal disease and is also a successful proof-of-concept for the SNP formulation technology. If approved in DME, it has the potential to provide a new option for patients whose current therapies are limited to intravitreal injections or implants.
OCS-01 is also in Phase 2 clinical development for Pain and Inflammation following ocular surgery.
DME is the build-up of fluid (edema) in a region of the retina called the macula. The macula is important for the sharp, straight-ahead vision that is used for reading, recognizing faces, and driving. DME is the most common cause of vision loss among people with diabetic retinopathy. About half of all people with diabetic retinopathy will develop DME. Although it is more likely to occur as diabetic retinopathy worsens, DME can happen at any stage of the disease.
DME can be treated with several therapies that may be used
alone or in combination.
Anti-VEGF Injection Therapy. Anti-VEGF drugs are injected into the vitreous gel to block a protein called vascular endothelial growth factor (VEGF), which can stimulate abnormal blood vessels to grow and leak fluid. Blocking VEGF can reverse abnormal blood vessel growth and decrease fluid in the retina. Available anti-VEGF drugs include Avastin (bevacizumab), Lucentis (ranibizumab), and Eylea (aflibercept). Lucentis and Eylea are approved by the U.S. Food and Drug Administration (FDA) for treating DME. Avastin was approved by the FDA to treat cancer, but is commonly used to treat eye conditions, including DME.
Most people require monthly anti-VEGF injections for the first six months of treatment. Thereafter, injections are needed less often: typically, three to four during the second six months of treatment, about four during the second year of treatment, two in the third year, one in the fourth year, and none in the fifth year. Dilated eye exams may be needed less often as the disease stabilizes.
Focal/grid macular laser surgery. In focal/grid macular laser surgery, a few to hundreds of small laser burns are made to leaking blood vessels in areas of edema near the center of the macula. Laser burns for DME slow the leakage of fluid, reducing swelling in the retina. The procedure is usually completed in one session, but some people may need more than one treatment. Focal/grid laser is sometimes applied before anti-VEGF injections, sometimes on the same day or a few days after an anti-VEGF injection, and sometimes only when DME fails to improve adequately after six months of anti-VEGF therapy.
Corticosteroids. Corticosteroids, either injected or implanted into the eye, may be used alone or in combination with other drugs or laser surgery to treat DME. The Ozurdex (dexamethasone) implant is for short-term use, while the Iluvien (fluocinolone acetonide) implant is longer lasting. Both are biodegradable and release a sustained dose of corticosteroids to suppress DME. Corticosteroid use in the eye increases the risk of cataract and glaucoma. DME patients who use corticosteroids should be monitored for increased pressure in the eye and glaucoma.
One of our most advanced product candidates, OCS-01, is in phase 2 clinical development for DME and also for Pain and inflammation following ocular surgery. The Phase 2 trial in DME (DX-211) with 144 patients was successfully completed providing the first proof-of-concept for a topical drug effect on a chronic retinal disease.
OCS-01 has been developed from Oculis’ solubilizing nanoparticle (SNP) technology, a proprietary platform that enables the formulation of drugs as non-invasive topical treatments and enhances their bioavailability in the relevant eye tissues.
If approved in DME, it has the potential to provide a new option for patients.