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Ophthalmology Management

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Quick Notes: June 9, 2023

FDA approves Novaliq's VEVYE for DED; FDA Clears CorNeat EverPatch non-degradable, synthetic tissue substitute; and more.

Ophthalmology Management June 9, 2023

  • Novaliq GmbH announced the FDA approved VEVYE (cyclosporine ophthalmic solution) 0.1% for the treatment of the signs and symptoms of dry eye disease (DED). VEVYE (development name CyclASol) is the first cyclosporine solution indicated for the treatment of signs and symptoms of DED with efficacy demonstrated after 4 weeks of treatment. VEVYE is cyclosporine, solubilized in a novel, water-free excipient and was designed to provide patients with a fast acting and well tolerable dry eye drug therapy. The solution does not contain water or anti-microbial preservatives, oils or surfactants. As a water-free product, there is no associated pH and no osmolarity.

  • CorNeat Vision's EverPatch, a synthetic tissue substitute, has been granted 510(k) clearance by the FDA. The CorNeat EverPatch is the first synthetic, non-degradable tissue-integrating matrix for use in ophthalmic surgeries. It is composed of a non-woven, polymer matrix that integrates with surrounding tissue and is intended to reinforce the sclera and aid the physical reconstruction of the ocular surface. This synthetic tissue substitute provides a sterile and non-degradable solution for patients. The CorNeat EverPatch will be launched initially in leading ophthalmic centers in the United States in Q3 2023, expanding nationwide later in the year.

  • Glaukos Corp. announced the completion of enrollment and randomization in its second Phase 3 confirmatory pivotal trial for Epioxa (Epi-on), its next-generation corneal cross-linking therapy for the treatment of keratoconus. The Epioxa multi-center, randomized, placebo and sham procedure controlled, Phase 3 confirmatory pivotal trial randomized 312 eyes and was designed to evaluate the safety and efficacy of Epioxa therapy in impeding the progression of and/or reducing maximum corneal curvature (Kmax) in eyes with progressive keratoconus. The study eyes were randomized in a 2:1 ratio to receive Epioxa therapy or placebo and sham procedure control treatment. The study’s primary efficacy endpoint is the mean change in Kmax from baseline to Month 12. Based on an agreement with the FDA, the study will be considered a success if the difference between the treatment and control arm in the primary efficacy endpoint is statistically significant and the difference is ≥ 1.0 diopter (D). Results from this second Phase 3 confirmatory pivotal trial together with the already-completed first Phase 3 pivotal trial are expected to support Glaukos’ targeted NDA submission for Epioxa by the end of 2024.

 

  • EyePoint Pharmaceuticals completed enrollment in the Phase 2 PAVIA clinical trial evaluating EYP-1901 as a potential 9-month treatment for moderate to severe non-proliferative diabetic retinopathy. PAVIA, a 12-month, randomized, controlled trial, enrolled 77 patients randomly assigned to one of two doses of EYP-1901 (approximately 2 mg or 3 mg) or to the control group receiving a sham injection. EYP-1901 is delivered with a single intravitreal injection in the physician's office. The primary efficacy endpoint of the trial is improvement of at least two diabetic retinopathy severity scale levels as of week 36 after the EYP-1901 injection. Secondary endpoints include reduction in vision-threatening complications, occurrence of diabetic macular edema and/or proliferative disease, retinal ischemia/nonperfusion and safety. For more information about the trial, click here.

 

  • OKYO Pharma Limited announced patients are now being dosed in the randomized portion of the Phase 2, multi-center, double-masked, placebo-controlled trial of topical ocular OK-101 to treat DED, following the 2-week placebo run-in period intended to minimize the placebo effect. The Phase 2 study is planned to enroll approximately 240 subjects with DED who will be randomly divided into three cohorts of 80 patients. The three cohorts will be comprised of one cohort treated with placebo, a second treated with 0.05% OK-101 and the third receiving 0.1% OK-101. The drug and placebo will be administered in both eyes twice daily for 12 weeks. The duration of a patient’s treatment will be approximately 14 weeks, including a 2-week run-in period and 12 weeks of treatment. For more information about the trial, click here.

 

  • Aviceda Therapeutics announced the dosing of its first patient with AVD-104 in its Phase 2 SIGLEC trial. This lead intravitreal asset is a novel glycan-coated nanoparticle, supported by a strong pre-clinical in vivo efficacy and safety profile, used for the treatment of geographic atrophy (GA) secondary to AMD. AVD-104 attacks two fundamental processes in GA by modulating critical inflammatory pathways through the inhibition of retinal macrophage inflammatory activity and repolarization of activated macrophages to their resolution states and through inhibition of complement cascade amplification. For more information about the trial, click here.

 

  • AOS (Advanced Ophthalmic Systems) launched a new remote visual acuity software platform that enables comprehensive visual assessments regardless of geographical location. The platform utilizes advanced algorithms and distance tracking techniques to ensure precise and reliable visual acuity measurements, resulting in accurate diagnoses and informed treatment decisions. In addition, synchronous communication enables seamless collaboration between patients and physicians, fostering instant feedback, personalized care and an improved patient-centered experience. The platform also offers a range of objective analysis features for eye health assessment and adheres to stringent security protocols and industry regulations, ensuring the confidentiality and privacy of patient information. 

 

  • Seenu M. Hariprasad, MD, the Shui-Chin Lee Professor of Ophthalmology, was appointed Chair of the Department of Ophthalmology and Visual Science at the University of Chicago Medical Center. He has been serving as interim chair since 2020. Dr. Hariprasad has served as an investigator in more than 45 national and international retina clinical trials evaluating various medications, sustained drug-delivery devices and surgical innovations.

 

  • Apple announced iOS 17, iPadOS 17 and watchOS 10 now offer new vision health features that encourage healthy behaviors that help reduce the risk of myopia. With watchOS 10, Apple Watch introduces the ability to measure time spent in daylight using the ambient light sensor. Children who do not have their own iPhone can use Family Setup to pair their Apple Watch to their parent’s iPhone, giving parents visibility into the amount of time their kids are spending in daylight with Health Sharing. The new Screen Distance feature uses the same TrueDepth camera that powers Face ID on iPhone and iPad to encourage users to move their device farther away after holding it closer than 12 inches for an extended period of time.

Quick Notes is published weekly. Unless otherwise noted, the information presented is based on press releases. Find earlier editions here. To submit a press release to be considered for publication, click here.