A non-surgical method for subretinal delivery by trans-scleral microneedle injection

Area of Science:

• Ophthalmology
• Regenerative Medicine
• Surgical Innovation

Background:

• Novel therapeutics for neurodegenerative eye diseases require optimal ocular administration.
• Current subretinal injection methods are invasive, complex, and limit clinical translation.

Purpose of the Study:

• To develop a novel, simple, and minimally invasive trans-scleral injection technique for subretinal delivery.
• To evaluate the safety and efficacy of this new technique in preclinical models.

Main Methods:

• Engineered a trans-scleral injection technique for non-surgical subretinal administration.
• Performed injections in rodent and rabbit models, assessing procedure time and microscope requirements.
• Conducted extensive safety evaluations, including retinal perforation, bleeding, and toxicity assessments in rats.
• Evaluated tolerance to repeated injections in the same eye.

Main Results:

• The technique enabled rapid (<1 min) subretinal injections without a surgical microscope.
• Demonstrated reliable delivery to the subretinal space with no retinal perforation or significant bleeding.
• Showed no evidence of retinal toxicity and good tolerance to repeated injections.
• Successfully administered therapeutics to the subretinal space in rodent and rabbit models.

Conclusions:

• The developed trans-scleral injection technique offers a safe, simple, and minimally invasive alternative for subretinal delivery.
• This approach may overcome limitations of current surgical methods, enhancing safety, efficacy, and accessibility of ocular therapies.
• Potential to enable non-surgical subretinal injections without vitrectomy for various retinal conditions.