OCS-01: A potential paradigm shift in Diabetic macular edema (DME) treatment

What is diabetic eye disease? 

Diabetic eye disease is a group of eye conditions that can affect people with diabetes and it can affect many parts of the eye, including the retina, the macula, the lens and the optic nerve.

 

Diabetic retinopathy  is an eye condition that can cause vision loss and blindness in people who have diabetes. It affects blood vessels in the retina (the light-sensitive layer of tissue in the back of your eye).

 

Diabetic macular edema is a consequence of diabetic retinopathy. It is characterized by the swelling of an area of the retina called the macula.

 

nei.nih.gov/health/diabetic/retinopathy

What is Diabetic Macular Edema (DME)?

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.

 

https://nei.nih.gov/health/diabetic/retinopathy

How is DME treated?

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.

 

https://nei.nih.gov/health/diabetic/retinopathy

OCS-01: A potential paradigm shift in DME treatment

OCS-01 successfully completed a Phase 2 trial in DME (DX-211) with 144 patients providing the first proof-of-concept for a topical drug effect in retinal edema.

 

OCS-01 also successfully completed another Phase 2 trial for the treatment of Inflammation and Pain following in Cataract Surgery. Following the completion of both Phase 2 trials, an End of Phase 2 meeting was conducted with FDA and the product candidate is now moving into phase III in both indications.

 

OCS-01 has been developed using the OPTIREACH solubilizing nanoparticle technology, a proprietary platform that enables the formulation of drugs as non-invasive topical treatments, a longer residence time on the eye surface and enhances their bioavailability in the relevant eye tissues.

 

If approved in DME, it has the potential to provide a new and potentially the FIRST non-invasive eye drop option for patients.

 

To learn more about the DX-211 Phase 2 Study Results of OCS-01 for the treatment of DME,

please click here

OCS-01 phase 2 study results in DME

Interviews with Dr. Pravin U. Dugel

Dr. Pravin U. Dugel
DME Treatments and Challenges

Dr. Pravin U. Dugel
OCS-01 Phase 2 Study Results

Dr. Pravin U. Dugel
OCS-01 Phase 2 Study Results

OCS-01 is an investigational drug and has not received regulatory approval for commercial use in any country. Some of the statements in the video reflect Dr. Pravin U. Dugel’s perception of the results from the phase 2 clinical trial in DME and some of the forward-looking statements reflect his opinion on potential future use of OCS-01 based on his clinical experience.