RegeneRx Versus Restasis: Who Hits The $2 Billion Dry-Eye Jackpot?

Allergan's (AGN) recent ploy to sell Restasis patents to the St. Regis Mohawk Tribe was perplexing to many. It also brought attention to Allergan's near term drug pipeline and the dynamics of the $1.8 billion U.S. dry-eye market. Allergan's Restasis controls 70% market share, while Shire's (SHPG) Xiidra controls over 20%. Xiidra is the only prescription eye drop indicated to treat both the signs and symptoms of dry-eye; Restasis is indicated to help increase tear production.

Xiidra has taken rapid share since entering the market in the second half of 2016. Now a manhunt is on for the next company to potentially disrupt the dry-eye market. RegeneRX (RGRX) and Aldeyra (ALDX) are two candidates. The question remains, "Who hits the dry-eye jackpot first?" I explain below.

About RegeneRx

RegeneRx is a clinical-stage biopharmaceutical company focused on the development of a novel therapeutic peptide, Thymosin beta 4, or TB4, for tissue and organ protection, repair and regeneration. The company has three product candidates in clinical development: [i] RGN-259, a preservative-free topical eye drop for regeneration of corneal tissues damaged by injury, disease or other pathology; [ii] RGN-352, an injectable formulation to treat cardiovascular diseases, central and peripheral nervous system diseases; and [iii] RGN-137, a topical gel for dermal wounds and reduction of scar tissue.

RGN-259 could eventually capture investors' attention. In July it completed Phase 3 clinical trial testing for dry-eye syndrome:

RegeneRx Biopharmaceuticals, Inc. ... a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced that its U.S. joint venture, ReGenTree LLC, has completed treatment of the last patient enrolled in its Phase 3 "ARISE-2" clinical trial testing RGN-259 preservative-free eye drops for dry eye syndrome ("DES").

ARISE-2 is a double-masked, placebo-controlled clinical trial that enrolled approximately 600 patients in the U.S. and was initiated less than 12 months ago. The trial is designed to replicate the clinical results achieved in ARISE-1, a Phase 2b/3 clinical trial in patients with DES.  Patient data will be scrubbed and validated prior to data lock and subsequent statistical analysis.  ReGenTree will report the results as soon as practicable thereafter.

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