Cannabinoid drug receives orphan drug designation for PVR prevention
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Tetra Bio-Pharma received orphan drug designation from the FDA for the cannabinoid drug PPP003 to prevent proliferative vitreoretinopathy, according to a press release.
The standard of care of repeat surgery “does not address the inflammatory basis of the condition,” which may lead to a higher risk for endophthalmitis, the release said.
“Our research in an experimental model of PVR has demonstrated that the synthetic cannabinoid, PPP003, can prevent this condition through activation of the type 2 cannabinoid receptor. If Tetra’s clinical trial can successfully demonstrate prevention of PVR in humans, PPP003 would become the first prescription eye medication approved for this condition,” Melanie Kelly, PhD, chief scientific officer at Tetra Bio-Pharma, said in the release.
The company will request a type B meeting with the FDA to discuss clinical development of the program.