Early Yutiq Approval Gives EyePoint Two Ophthalmic Drugs To Launch In 2019

Yutiq, for posterior uveitis, will compete with two existing steroid products and should launch during the first quarter of 2019. EyePoint’s Dexycu, although approved in February, is still in scale-up and probably will launch a bit later.

EyePoint Pharmaceuticals Inc. CEO Nancy Lurker noted that the US FDA’s early approval of the firm’s posterior uveitis therapy Yutiq, weeks ahead of a Nov. 5 action date, gives EyePoint the opportunity to promote and highlight the product during the American Association of Ophthalmology (AAO) meeting at the end of October.

“AAO is the largest gathering of ophthalmologists in the world, and we planned meticulously for this meeting in anticipation of a possible early approval,” the exec said during an Oct. 15 call on the approval. Yutiq is a non-bioerodible, single-dose intravitreal micro-insert of 0.18 mg of the steroid fluocinolone acetonide, administered in a physician’s office and designed to release continually over 36 months. It was approved Oct. 12 to treat chronic, non-infectious posterior uveitis.

Created by the merger of pSivida Inc. and Icon Bioscience Inc. in March, EyePoint now has two FDA-approved products that it plans to launch in 2019. [See Deal] Icon brought to the new company Dexycu, a long-acting, intracameral formulation of dexamethasone approved by the FDA in February to treat inflammation associated with cataract surgery. (Also see "Deal Watch: Allogene Gets Pfizer's Off-The-Shelf CAR-T Program, $300m Series A Backing" - Scrip, 3 Apr, 2018.)

Lurker said EyePoint plans to launch Yutiq (previously known as Medidur) during the first quarter of 2019, and hopes to bring Dexycu to market during the first half of next year. While Dexycu was approved this past February, launch has been delayed in order to scale-up the product almost from scratch, she explained.

“We're working very hard to do a manufacturing scale-up on Dexycu,” Lurker said. “I want to remind people that when we closed our transaction with Icon, which had Dexycu, they [had] spent no money on any purchase of manufacturing supplies, any validation testing for scale-up. And as a result, we had to obviously go into the supply chain, and that takes time to get all the requisite components for the delivery device as well as the API [active pharmaceutical ingredient] for the drug, then do our validation batches and then produce the commercial supplies.”

“At this point, I don't want to make a prediction as to exactly when in the first half of 2019 [the Dexycu launch will occur],” she added.

Both Yutiq and Dexycu are extended-release products but use different technologies. (Also see "pSivida On Cusp Of Uveitis Filings As EU Licensing Deal Nears" - Scrip, 14 Jun, 2017.) Yutiq utilizes legacy pSivida’s Durasert drug delivery technology, also incorporated in Alimera Sciences Inc.’s diabetic macular edema therapy Iluvien; Dexycu uses Icon’s proprietary Verisome delivery technology.

Competing With Shorter-Acting Uveitis Therapies

In posterior uveitis, Yutiq will compete against Bausch Health Companies Inc.'s fluocinolone acetonide intravitreal implant 0.59 mg Retisert (which was licensed from pSivida in 2005) and Allergan PLC's dexamethasone intravitreal implant 0.7 mg, Ozurdex. [See Deal]

EyePoint believes Yutiq will offer advantages over the competition because of its longer 36-month duration of effect. Retisert lasts 30 months but releases higher levels of active ingredient, which is associated with increased intraocular pressure. Retisert also must be implanted surgically, while Yutiq can be administered in a physician’s office. Ozurdex’s therapeutic benefit lasts for six months.

Yutiq provides “more continuous drug delivery over a longer time period, avoiding the peaks and valleys that current treatment options do not address effectively,” Lurker said. “Consistent drug delivery over an extended period of time is an important element of treatment as the overall regimen aims to prevent flares, which can lead to blindness.”

EyePoint estimates that between 55,000 and 120,000 US patients have posterior uveitis, which it notes is the third-leading cause of blindness. (Also see "pSivida Moving Forward With Late-Stage Eye Drug" - Scrip, 23 Dec, 2015.) Systemic steroid therapy is the typical front-line treatment but usually leads to dose-limiting side effects over time, often followed by steroid-sparing therapy with systemic immunosuppressive drugs that have their own safety issues, including potential increased cancer risk.

Based on preliminary discussions, Lurker expects that familiarity with Alimera’s Iluvien, combined with posterior uveitis’ propensity to lead to blindness, will create an advantageous position with US payers. Yutiq incorporates both the same active ingredient and the same delivery system as Iluvien, which has been on the market for roughly four years. (Also see "Alimera, pSivida win FDA nod for Iluvien, finally" - Scrip, 29 Sep, 2014.)

“Most of the payers are very familiar with the Durasert technology and the implant,” the exec said. “As a result, they are very open to using the implant for Yutiq … because uveitis is a very small orphan disease and the price is not going to be priced that different from Iluvien. They're actually quite open to simply making a quite seamless process to allow the drug to be administered.”

EyePoint will use a contract sales organization to market Yutiq; Lurker estimated the company will need only about 10 reps to detail the product because of the limited number of doctors who treat uveitis patients. The Watertown, Mass.-based firm will launch both its products domestically, while using partners for potential ex-US commercialization, she said. Alimera holds European rights to Yutiq in uveitis.

The approval is based on a pair of Phase III studies, both of which met a primary endpoint of recurrence of disease after six months compared to sham therapy. In the first 129-patient study conducted at 16 US and 17 ex-US sites, there was an 18.4% recurrence rate for Yutiq compared to 78.6% for control. The second trial, in 153 patients in India, showed a 27.6% recurrence rate for the study drug versus 85.7% for control.

Both studies are being continued for 24-month and 36-month follow-up. EyePoint will present the 24-month follow-up data at AAO later this month and plans to present 36-month data in 2019.