Early pipeline developments within the diabetic macular oedema (DME) space have recently garnered interest following the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting. The spotlight was placed on many up-and-coming pharmacotherapies, one of which was Ashvattha Therapeutics’ D-4517.2.

Ashvattha Therapeutics’ D-4517.2 is currently in Phase I development for both DME and age-related macular degeneration (AMD). The drug is of special interest due to its potential to address vital unmet needs within the DME space. Clinical trial results have shown that doses of 0.25mg/kg, 0.50mg/kg and 1.0mg/kg of D-4517.2 were well-tolerated and safe in healthy subjects; adverse events were only a result of the route of administration and not due to the therapy itself, and were addressed with changes to the method of injection. Phase II trials are projected to initiate later this year, with the trial advancing by incorporating a new development, which will undoubtedly shake the DME space.

Despite D-4517.2 being an anti-vascular endothelial growth factor (VEGF) therapy, similar to many other treatments for DME on the market (including the gold standard, Bayer’s Eylea (aflibercept)), D-4517.2 stands out by offering a feature unique among anti-VEGF treatments: it may be self-administered by the patient using an autoinjector. This has many implications for the patient; firstly, it helps to address the heavy treatment burden experienced by DME patients.

Currently, patients are obliged to visit the hospital an average of six to eight times a year in order to receive their necessary treatment. Many patients receiving treatment for DME are of working age, and in most cases have other comorbidities, which they must also tend to. D-4517.2 addresses this issue by enabling patients to perform the procedure in the comfort of their own home and at a time convenient to their schedule, thus significantly cutting down in-hospital treatment days.

In addition, the drug’s subcutaneous route of administration, as opposed to the intravitreal route common for DME treatments, may make the therapy all the more favourable among DME patients. This would tackle long-standing issues with patient compliance due to some patients fearing intravitreal injections while simultaneously averting the adverse events related to the intravitreal injection route.

Key opinion leaders (KOLs) interviewed by GlobalData have stressed both patient burden and patient compliance as key unmet needs, with some stressing the importance of finding new ways to avoid adverse events related to treatment by avoiding the use of intravitreal injections and employing less invasive routes of administration. The need to reduce treatment days for DME patients was also echoed by many KOLs.

There is no doubt that the practicality of D-4517.2 has the potential to make it favourable by patients and clinicians alike should it reach the DME market, and there are high hopes for the forthcoming Phase II trial. Provided the Phase II trial yields positive results, this new therapy may be set on a trajectory to compete directly with long-standing anti-VEGF drugs across the ophthalmological space.