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Eyepoint Signs New Agreement for Expanded Access of DEXYCU within America’s largest Integrated Delivery Systems

16 Dec Eyepoint Signs New Agreement for Expanded Access of DEXYCU within America’s largest Integrated Delivery Systems

Eyepoint Pharmaceuticals (NASDAQ: EYPT), a speciality biopharmaceutical Company engaged in developing ophthalmic solutions for the treatment of eye diseases, announced the signing of a two-year contract with one of the largest integrated delivery systems in the U.S to offer DEXYCU within its network, along with being granted a preferred vendor status by the network as per a Company statement. The agreement will open up new markets for the Company in key U.S. regions, including California, Washington, Georgia, Colorado and Mid-Atlantic States.

Nancy Lurker, President and CEO of EyePoint Pharmaceuticals commented

“This newest agreement makes DEXYCU available to the 8.5 million U.S. patients managed by this integrated delivery system. We continue to receive strong reception and increasing adoption of this innovative product from physicians and ambulatory surgical centres across the U.S. DEXYCU has the potential to replace the burdensome post-cataract surgery steroid regimen by providing an easy to administer, extended release treatment option with a favorable safety profile.”

Dexycu, the first and only FDA-approved, single-dose, sustained-release, intracameral steroid, is a dexamethasone intraocular suspension 9% corticosteroid, indicated for the treatment of postoperative inflammation in cataract surgeries. It is meant to be administered at the end of ocular surgery, to suppress inflammation by inhibiting multiple inflammatory cytokines, resulting in decreased edema, fibrin deposition, capillary leakage and migration of inflammatory cells as per its prescribing information.

Eyepoint Pharmaceuticals (NASDAQ: EYPT)

Market Cap: $162M; Current Share Price: 1.50 USDChart
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The American Academy of Ophthalmology defines cataract as the clouding of the lens through which light rays are refracted and is characterized by blurry or unclear vision, double images, sensitivity to light, difficulty in seeing well at night and seeing dull or faded color instead of natural colors. The growing geriatric population, improved life efficiency, chronic conditions such as diabetes and prolonged exposure to sun are some of the causes for growth in the number of cataracts.

Cataract surgery is one of the most common elected surgical procedures around the world, and affects 25 million people in the U.S alone, according to research from the prevent blindness study. This number is projected to reach 45.6 million by 2050. The surgery results in inflammatory response, which needs to be controlled immediately, as otherwise it may result in complications such as synechiae, uveitis, and secondary glaucoma. This is achieved by use of corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDs).

Eyepoint Pharmaceuticals places the number of cataract surgeries in 2018 at 4.8 million, with expectation of an 8 percent growth rate in the U.S. This presents a valuable opportunity for companies that can overcome the limitations of existing treatment options such as poor patient adherence, repeated call backs and follow-up with physicians that are disruptive and unproductive and adverse outcomes, such as infections, due to non-adherence to the treatment regimen. The need of the hour are sustained release medication that continues to work over a long period of time, thereby reducing the risk of poor compliance and improving patient outcomes.

Eyepoint Pharmaceuticals leverages its expertise in the area of sustained-release drug delivery, to develop treatments for eye related and other localized chronic conditions. The Company’s proprietary DurasertTM Technology enables sustained-release delivery of small molecules for up to three years with a single injection, which has been put to use in four FDA-approved products. Additionally, the Company’s VerisomeTM technology enables the creation of sustained release of small molecules over 1-6 months with a single injection.

EyePoint has 5 FDA-approved sustained-release treatments in ophthalmology to its credit, namely DEXYCU (dexamethasone intraocular suspension) 9%, YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18 mg, ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg (licensed to Alimera Sciences), Retisert® (fluocinolone acetonide intravitreal implant) 0.59 mg (licensed to Bausch & Lomb).

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The Company also manufactures YUTIQ, a fluocinolone acetonide intravitreal implant 0.18 mg, indicated for the treatment of chronic non-infectious uveitis, affecting the posterior segment of the eye. The device is capable of delivering sustained release of fluocinolone for up to 36 months and demonstrated an ability to reduce uveitis recurrence. Eyepoint is currently engaged in developing a shorter-duration sustained release fluocinolone acetonide product for posterior segment uveitis.

Eyepoint is developing a pipeline focussed on diverse ophthalmic conditions such as wet age-related macular degeneration, glaucoma, osteoarthritis, and other diseases. The Company’s pipeline also has Durasert indicated for the treatment of wetAMD and a potential treatment of Glaucoma through a collaboration agreement.

Risk Assessment

  • The Company’s strategy is to build a robust pipeline that addresses diverse ophthalmic conditions and be recognized as a go-to partner for commercialization in ophthalmology. To this end the Company is pursuing strategic partnership with leading players in the market, while going alone as far as Dexycu and Yuitq are concerned. Both drugs address a very large unmet need in the field of post-surgical inflammation and have the potential to be breakthrough products with a market potential of nearly $2.5B.
  • Eyepoint is backed by an experienced management team with extensive experience in commercial product launches and clinical development, which can prove to be advantageous in helping navigate the Company through challenges faced during clinical trials and regulatory approvals.
  • The Company is looking at both in-license and out-license opportunities under multiple product categories as well as its proprietary Durasert™ and Verisome® technologies.
  • Eyepoint had two product launches in 2019, both of which have received a permanent J-Code with minimal reimbursement issues. The Company has a dedicated team of key account managers that are targeting high-volume ambulatory surgical centers (ASCs) and uveitis specialists to boost product sales.
  • The Company has key access agreements with U.S Department of Veterans Affairs, with DEXYCU® and YUTIQ® added to the Federal Supply Schedule for the benefit of Nine Million VA beneficiaries and a three-year agreement with Vizient, with a strong network of over 50% of the nation’s acute care providers, including 95% of the nation’s academic medical centers, and more than 20% of ambulatory care providers as per the Company.
  • Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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