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- Opthea (OPT) has released positive results from the Phase 2a Trial of its treatment for diabetic macular edema, the primary cause of blindness in diabetics
- The trial is evaluating the efficacy and safety of Opthea’s OPT-302 treatment used in conjunction with Eylea, an existing treatment for the disease
- The combination therapy was well-tolerated and after 12 weeks more than half of the patients experienced a clinically relevant improvement in their vision
- This was however similar to the proportion of patients in the control group who reached the same primary endpoint for vision improvement
- Final 24-week assessments for durability and safety will be completed this month and the results will be reported later this year
- Opthea’s share price is down 7.14 per cent to $3.12 per share at 2:06 pm AEST
Opthea (OPT) has released positive results from the Phase 2a Trial of its treatment for diabetic macular edema (DME).
The trial is evaluating the use of Opthea’s OPT-302 treatment in conjunction with Eylea to improve vision in people with DME, the leading cause of blindness among diabetics.
These results show the combination therapy was well-tolerated and after 12 weeks, more than half of the patients experienced a clinically relevant improvement in their vision.
Diabetic macular edema
DME is caused by blood vessel dysfunction and the accumulation of fluid in the macula, a region of the central retina at the back of the eye, and is the primary cause of vision loss or impairment among diabetics.
The elevated blood sugar levels associated with diabetes can lead to inflammation, blood vessel dysfunction and inadequate oxygen or hypoxia. This, in turn, can lead to elevated levels of growth factors VEGF-A and VEGF-C, prompting fluid accumulation in the macula and retinal thickening.
OPT-302 is an inhibitor VEGF-C and VEGF-D and is being developed for use in tandem with VEGF-A inhibitors to improve the vision of DME patients as well as wet age-related macular degeneration patients.
Unlike the standard of care treatments, Lucentis® and Eylea®, which are VEGF-A inhibitors, Opthea’s OPT-302 treatment inhibits VEGF-C and VEGF-D growth factors, members of the same family of proteins.
The trial results in focus
The trial included patients who experienced persistent DME despite VEGF-A monotherapy, recruited from 53 sites in the United States, Israel, Australia and Latvia, and it aimed to evaluate the efficacy and safety of the treatment.
The primary efficacy endpoint was reached, with 52.8 per cent of patients improving their Best Correct Visual Acuity score by five or more letters at the 12-week mark.
This was similar to the Eyela control group in which 60 per cent of participants improved their acuity score by five or more letters. However, Opthea noted that a higher proportion of those given the combination therapy improved their score by equal to or great than 10 or even 15 letters than in the control group.
Additionally, a lower proportion of patients on the combination treatment saw their vision deteriorate by five or more letters. A total of 2.7 per cent of the OPT-302 combination group saw a decline of that size compared to 5 per cent in the control group.
In regards to the other primary endpoint, the trial found that the tolerability of the combination therapy was consistent with the Eylea standard of care.
Study Investigator on the trial, Dr Arshad Khanai, said he was encouraged by the results and hopes they will translate into additional treatment options for patients.
“The well-tolerated safety profile that we have consistently observed with this molecule is encouraging and the biological activity observed in this trial, in patients that are very difficult to treat and with different prior-treatment histories, bodes well for the further clinical development of OPT-302.”
“We believe that the results of this Phase 2a DME trial, together with the positive outcomes of the company’s Phase 2b trial with OPT-302 in wet AMD, further validate Opthea’s approach to target VEGF-C and VEGF-D to address the substantial unmet medical need for patients with these retinal eye diseases despite the availability of selective inhibitors of VEGF-A,” he elaborated.
Final 24-week visits will be completed this month and the analysis is expected to be reported later this year.
Opthea’s share price is down 7.14 per cent to $3.12 per share at 2:06 pm AEST.
