Propranolol 0.2% Eye Micro-Drops for Retinopathy of Prematurity: A Prospective Phase IIB Study

Area of Science:

• Ophthalmology
• Neonatology
• Pharmacology

Background:

• Oral propranolol has shown potential in reducing retinopathy of prematurity (ROP) progression but carries safety concerns.
• Previous studies indicated that 0.1% propranolol eye micro-drops were well-tolerated but insufficiently effective for stage 2 ROP.

Purpose of the Study:

• To evaluate the safety and efficacy of 0.2% propranolol eye micro-drops in newborns with stage 1 ROP.
• To compare ROP progression in infants treated with propranolol eye micro-drops against a historical control group.

Main Methods:

• A multi-center, open-label trial involving 98 newborns with stage 1 ROP.
• Serial ophthalmologic examinations, hemodynamic, respiratory, and biochemical monitoring.
• Comparison of ROP progression with a historical control group from the same centers.

Main Results:

• Propranolol 0.2% eye micro-drops were well-tolerated with no observed adverse effects.
• ROP progression to stage 2 or 3 plus was significantly lower compared to historical data (RR 0.521).
• Mean propranolol plasma levels remained below the safety threshold of 20 ng/mL.

Conclusions:

• Propranolol 0.2% eye micro-drops appear safe and effective in reducing ROP progression compared to historical controls.
• Early oral propranolol administration may be associated with more aggressive ROP, indicating treatment timing is critical.
• Further randomized placebo-controlled trials are necessary to validate these findings.