EyePoint Pharmaceuticals, Inc. (EYPT - Free Report) announced that the FDA has approved Yutiq (fluocinolone acetonide intravitreal implant) for treating chronic non-infectious uveitis affecting the posterior section of the eye.
Yutiq is a tiny micro-insert that utilizes EyePoint’s Durasert drug delivery technology, containing 0.18 mg fluocinolone acetonide, designed to release consistently over a period of 36 months and is the first long-lasting micro-insert to be approved by the FDA.
The nod was based on clinical data from two phase III randomized, sham injection-controlled, clinical studies with patient follow-up continuing for three years. Both evaluations met the primary efficacy endpoint of preventing recurrent uveitis flares after six and 12 months. The analyses demonstrated that Yutiq considerably reduced the rate of recurrent uveitis flares.
EyePoint expects to report the 24-month and 36-month patient follow-up from the first phase III clinical study on Yutiq by the end of 2018 and the first half of 2019, respectively.
Notably, in March 2018, the FDA accepted EyePoint’s New Drug Application (NDA) for Yutiq and set an action date of Nov 5, 2018. However, this approval comes before the stipulated time and is a great boost to the company. EyePoint plans to launch Yutiq in the United States during the first quarter of 2019.
The company is also designing a next-generation, shorter-duration treatment for the same indication, based on the Durasert drug delivery technology. The company plans to file an application for this insert next year.
However, EyePoint is likely to face stiff competition from the already available products approved for the given indication. AbbVie's (ABBV - Free Report) Humira and Allergan’s (AGN - Free Report) Ozurdex are approved for a similar disease.
The company currently has strategic collaboration with Alimera Sciences (ALIM - Free Report) and several other pharma companies.
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