Visara, Inc. announced in a press release that it has entered into an exclusive license agreement with Wuhan Hiteck Biological Pharma Co., Ltd. for the development and commercialization of VIS-102 (HT006.2.2), an investigational modified recombinant human nerve growth factor (rhNGF) therapy designed to restore corneal health in patients with neurotrophic keratitis (NK).

VIS-102 incorporates targeted modifications to the NGF amino acid sequence intended to improve resistance to enzymatic degradation and maintain stability under refrigeration. These changes could allow VIS-102 to be supplied in ready-to-use, single-dose units, the company said.

According to Visara, phase 1b data among patients in China with severe NK showed that in the highest dose cohort of VIS-102, after a single 8-week course, subjects achieved 50% complete corneal healing, whereas 14% of those in the vehicle control group had complete corneal healing at week 4. In the study, those on vehicle then crossed over to active treatment from week 5 to week 8 and achieved 43% complete corneal healing after a 4-week course of VIS-102.

Treatment-related ocular adverse events were all mild and consistent with trials of rhNGF. No subjects withdrew or discontinued the study due to a related adverse event. The study will continue with an expansion phase to evaluate the highest dose at both 6 times daily and 3 times daily 8-week regimens in Chinese patients with NK, the company said.

Under the terms of the license agreement, Visara will receive exclusive rights to develop and commercialize VIS-102 worldwide, excluding Greater China. Hiteck will receive an upfront payment as well as potential development, regulatory, and commercial milestone payments and tiered royalties on net sales, the company said.