Ashvattha Therapeutics has recently presented the safety data from a Phase 1 study of its lead diabetic macular edema (DME) candidate D-4517.2 at the Association for Research in Ophthalmology (ARVO). Against this backdrop, the drug has potential to address a key unmet need for drugs that reduce patient burden and compliance-related issues, says GlobalData, a leading data and analytics company.

Currently, patients receiving anti-vascular endothelial growth factor (VEGF) therapy for DME are obliged to visit the hospital six to eight times a year on average. However, despite being an anti-VEGF therapy, similar to many other treatments for DME including the gold standard Bayer’s Eylea (aflibercept), D-4517.2 is unique among anti-VEGF treatments as it can be self-administered by the patient using an autoinjector.

Sara Reci, Pharma Analyst at GlobalData, comments: “The potential of D-4517.2 to be self-administered has many vital implications for DME patients. Firstly, it helps to address the heavy treatment burden by reducing in-hospital treatment days. 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.

“Furthermore, its subcutaneous route of administration, as opposed to the intravitreal route common for DME treatments, may make the therapy all the more favorable among DME patients, thus tackling 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. Additionally, the need to reduce treatment days for DME patients was echoed by many KOLs.

Reci concludes: “There is no doubt that D-4517.2 has potential to be favored 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.”