Eyepoint Pharmaceuticals Inc (NASDAQ:EYPT) has been on something like a rampage. And for good reason. The company has put several pieces together, now eventuating into a clean and clear approval for one of its most important assets – though not its most important, which is what is so compelling here. To wit: The company just announced that the U. S. Food and Drug Administration (FDA) has approved YUTIQ (fluocinolone acetonide intravitreal implant) for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.
According to the release, “YUTIQ utilizes the Company’s Durasert drug delivery technology and is a non-bioerodible intravitreal micro-insert in a drug delivery system containing 0.18 mg fluocinolone acetonide, designed to release consistently over 36 months. YUTIQ is supplied in a sterile single-dose preloaded applicator that can be administered in the physician’s office. In clinical trials, YUTIQ significantly reduced the rate of recurrent uveitis flares versus sham, and the most common adverse reactions reported were cataract development and increase in intraocular pressure (IOP).”
Eyepoint Pharmaceuticals Inc (NASDAQ:EYPT) promulgates itself as a specialty biopharmaceutical company that develops and commercializes ophthalmic products for the treatment of eye diseases.
The company’s lead product is ILUVIEN for the treatment of diabetic macular edema; and product candidate is YUTIQ, a non-erodible fluocinolone acetonide insert for the treatment of non-infectious posterior uveitis that is in the Phase III clinical trials.
It also offers Retisert (fluocinolone acetonide intravitreal implant), a sustained-release implant for the treatment of posterior segment uveitis. In addition, the company has developed DEXYCU (dexamethasone intraocular suspension), an intraocular product for the treatment of postoperative ocular inflammation; and Vitrasert (ganciclovir), a sustained release implant for the treatment of cytomegalovirus retinitis.
Further, it develops YUTIQ shorter-actinguveitis for the treatment of posterior segment uveitis; and Durasert tyrosine kinase inhibitor for the treatment of wet age-related macular degeneration.
Additionally, the company’s development program focuses on developing sustained release products using its Durasert and Verisome technology platforms to deliver drugs to treat chronic diseases.
It sells its products primarily in the United States and Europe. The company has strategic collaborations with Alimera Sciences, Inc., Bausch & Lomb, and Enigma Therapeutics Limited. The company was formerly known as pSivida Corp. and changed its name to EyePoint Pharmaceuticals, Inc. in March 2018.
EyePoint Pharmaceuticals, Inc. was founded in 1987 and is headquartered in Watertown, Massachusetts.
As noted above, EYPT just announced that the FDA has approved YUTIQ (fluocinolone acetonide intravitreal implant) for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. This announcement has popped the stock higher, which certainly isn’t surprising. EYPT shareholders are now sitting on about 5% in gains over the past week.
Panning back a bit, shares of the stock have powered higher over the past month, rallying roughly 47% in that time on strong overall action.
“The approval of YUTIQ by the FDA is a significant milestone achieved by the Company and marks the second approved ophthalmic product in our pipeline that we plan to commercialize ourselves in the U.S.,” said Nancy Lurker, EyePoint’s President and Chief Executive Officer. “YUTIQ was developed internally by our research team and this approval further validates our capabilities to successfully design, develop and gain regulatory approval for an ophthalmology product to address a disease with high unmet need. Chronic non-infectious uveitis affecting the posterior segment of the eye is the third leading cause of blindness in the U.S. We anticipate a product launch in the first quarter of calendar 2019 and look forward to bringing this innovative treatment to patients suffering from this disease.”
Eyepoint Pharmaceuticals Inc (NASDAQ:EYPT) generated sales of $715K, according to information released in the company’s most recent quarterly financial report. That adds up to a sequential quarter-over-quarter growth rate of -23% on the top line. In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($38.8M against $21.7M).