Curative Biotech Engages Sterling Pharma for Clinical Supply of Metformin-Based Ophthalmic Treatment

Curative Biotechnology is engaging Sterling Pharmaceutical Services to manufacture clinical supply of a metformin-based topical ophthalmic formulation.

Sterling, a Dupo, Ill.-based CDMO, specializes in formulation development and manufacturing of sterile products. It will support production of eye drops intended for use in Curative’s planned first in human clinical study. Curative is a development-stage biomedical company focusing on novel therapies for degenerative eye diseases.

How Sterling Contributes to Metformin Advancement

The intent of the Phase I human study is to treat dry age-related macular degeneration (AMD). Curative is also planning a clinical K9 study in phosphodiesterase (PDE6)-associated retinal degeneration. PDE6 is a peripheral membrane protein; it links to the signaling-transducing compartment of rod and cone photoreceptors.

In dogs, PDE6-associated retinal degeneration is a genetic, early onset disease. It may, however, provide translational insights that are relevant to human retinitis pigmentosa.

Curative is currently developing its topical treatment for intermediate and late stage AMD.

NIH and Curative Have Prior Agreement

Curative Executive Chairman Paul Michaels echoed the company position that having a manufacturing pathway to clinical evaluation is critical.

“Engaging Sterling Pharmaceutical Services represents an important step in advancing our metformin-based ophthalmology platform toward clinical development,” Michaels said. “We are pleased to be working with an experienced manufacturing partner capable of supporting production of sterile ophthalmic formulations.”

Robert T. Flynn, Sterling CEO, agreed.

“We are pleased to support Curative Biotechnology as it advances development of its topical ophthalmic program,” Flynn said.

Previously, Curative announced its strategy to advance platform development under an exclusive, worldwide license from the National Eye Institute. This is a division of the National Institutes of Health (NIH). The planned first in human clinical study is part of Curative’s Cooperative Research and Development Agreement with NIH.