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RGN-259 Significantly Improves Signs and Symptoms of Severe Dry Eye in Phase 2 Clinical Trial
June 20, 2012
ROCKVILLE, Md.--(BUSINESS WIRE)--RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) (“the Company” or “RegeneRx”) is reporting preliminary results from a double-masked, vehicle-controlled, physician-sponsored Phase 2 clinical trial evaluating RGN-259 for the treatment of severe dry eye. RGN-259 (Tβ4 preservative-free eye drops) was found to be safe and well-tolerated and met key efficacy objectives with statistically significant sign and symptom improvements, compared to vehicle control, at various time intervals, including 28 days post-treatment.
Nine patients with severe dry eye (18 eyes) were treated with RGN-259 or vehicle control six times daily over a period of 28 days. They were evaluated upon entering the study after a two week washout period, at weekly intervals during the treatment phase, at the end of the 28-day treatment period, and at a follow-up visit 28 days after treatment. Statistically significant differences in sign and symptom assessments, such as ocular discomfort and corneal fluorescein staining, were seen at various time points throughout the study. Of particular note were the differences between RGN-259 and vehicle control 28 days post-treatment, or the follow-up period. The RGN-259-treated group had a 35.1% reduction of ocular discomfort compared to vehicle control (p=0.0141), and a 59.1% reduction of total corneal fluorescein staining compared to vehicle control (p=0.0108).
Consistent with the reduction of ocular discomfort and fluorescein staining at the 28-day follow-up visit, other improvements seen in the RGN-259-treated patients included tear film breakup time and increased tear volume production. Likewise, these improvements were seen at other time points in the study.
The researchers are conducting additional analysis of the patient groups and will be submitting a manuscript for publication later this year.
“While the RGN-259 patients showed impressive clinical improvements over vehicle control patients during treatment, data from the 28-day follow-up period were equally impressive. Twenty-eight days after completing treatment, ocular improvements in the vehicle control group reverted toward their original pre-treatment scores while the ocular improvements in the RGN-259 group remained relatively stable, suggesting a more lasting clinical effect with RGN-259. This is an important observation when comparing an active compound to a control, such as an eye lubricant, that can sometimes provide limited but temporary relief for dry eyes,” commented Dr. Steven Dunn, holder of the physician-sponsored IND and an ophthalmologist at Michigan Cornea Specialists in Southfield, Michigan.
Nine patients with severe dry eye (18 eyes) were treated with RGN-259 or vehicle control six times daily over a period of 28 days. They were evaluated upon entering the study after a two week washout period, at weekly intervals during the treatment phase, at the end of the 28-day treatment period, and at a follow-up visit 28 days after treatment. Statistically significant differences in sign and symptom assessments, such as ocular discomfort and corneal fluorescein staining, were seen at various time points throughout the study. Of particular note were the differences between RGN-259 and vehicle control 28 days post-treatment, or the follow-up period. The RGN-259-treated group had a 35.1% reduction of ocular discomfort compared to vehicle control (p=0.0141), and a 59.1% reduction of total corneal fluorescein staining compared to vehicle control (p=0.0108).
Consistent with the reduction of ocular discomfort and fluorescein staining at the 28-day follow-up visit, other improvements seen in the RGN-259-treated patients included tear film breakup time and increased tear volume production. Likewise, these improvements were seen at other time points in the study.
The researchers are conducting additional analysis of the patient groups and will be submitting a manuscript for publication later this year.
“While the RGN-259 patients showed impressive clinical improvements over vehicle control patients during treatment, data from the 28-day follow-up period were equally impressive. Twenty-eight days after completing treatment, ocular improvements in the vehicle control group reverted toward their original pre-treatment scores while the ocular improvements in the RGN-259 group remained relatively stable, suggesting a more lasting clinical effect with RGN-259. This is an important observation when comparing an active compound to a control, such as an eye lubricant, that can sometimes provide limited but temporary relief for dry eyes,” commented Dr. Steven Dunn, holder of the physician-sponsored IND and an ophthalmologist at Michigan Cornea Specialists in Southfield, Michigan.