17 Dec Emerging Innovations in Cataract Surgery Industry
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 (NASDAQ: EYPT)
Market Cap: $159M; Current Share Price: 1.47USD
Data by YCharts
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).
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.
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.
Oculis S.A (Private)
Oculis is a clinical stage biopharmaceutical company focussed on developing novel solutions for ophthalmic conditions. The Company recently launched a phase 2b clinical study to evaluate the safety and efficacy of OCS-01, indicated for treatment of inflammation and pain following cataract surgery, across 20 specialized ocular surgery centres in the U.S. OCS-01, a topical formulation of dexamethasone developed using the Company’s proprietary Solubilizing NanoParticle (SNP) technology platform has the potential to be the first once daily topical steroid to treat inflammation and pain following ocular surgery.
Oculis solubilizing nano-particle (SNP) drug-delivery technology leverages specific cyclodextrin compounds to create stable formulation for complex drug/cyclodextrin nanoparticles. The use of drug/ cyclodextrin complexes increases the drug solubility in the aqueous tear fluid thereby improving permeation and bioavailability in the eye tissues.
The Company is developing therapeutics for both front and back-end of the eye, including their lead program evaluating OCS-01 in patients with DME, and is expected to announce results by early 2020. In addition, the Company’s pipeline also consists of OCS-02, a novel topical anti-TNF alpha antibody in Phase 2 for inflammatory eye diseases, which was in-licensed from Novartis.
Oculis aims to bring about a treatment shift for back-of-the-eye diseases which are currently treated through invasive methods such as intraocular injections or implants. The Company is backed by leading investors such as Bay City Capital, Brunnur, Nan Fung Life Sciences, NVF, Pivotal to name a few.
Eyenovia, Inc (NASDAQ: EYEN)
Market Cap: $55M; Current Share Price: 3.24 USD
Data by YCharts
The Company is developing MicroStat, a first-in-class fixed-combination micro-formulation product containing phenylephrine 2.5% -tropicamide 1%, for pharmacologic mydriasis, intended to improve the efficiency of eye dilations that are a prerequisite for diabetic eye check-ups as well as cataract surgeries. Eyenovia is targeting the development of clinical microdosing of advanced versions of well established ophthalmic pharmaceutical agents, using its proprietary high-precision targeted ocular delivery system, which has the potential to replace the existing eye dropper delivery. This can result in improved safety, tolerability and patient compliance.
The Company’s proprietary Optejet technology overcomes the limitations in conventional eyedropper bottles that overdose the eye much beyond its capacity for only 6-8 μL of medication. The use of microdosing by the Optejet dispenser simplifies the process of self-administration and makes it more convenient and reliable; the device comes equipped with smart technology that enables patients to keep track of their therapy through reminders and adherence measures.
The Company has announced positive results from its second phase 3 study namely Mist-2 evaluating the safety, efficacy and tolerability of MicroStat fixed-combination formulation for the treatment of pharmacologic mydriasis, or eye dilation. The study had 70 subjects who demonstrated superior mydriatic effect when compared to a placebo. In addition the results in the MicroStat group showed that 93% of eyes achieved 6 mm or greater pupil dilation and 68% of eyes achieved 7 mm or more pupil dilation at 35 minutes post-administration when compared to the results from the group on placebo as per the Company.
Eyenovia’s clinical pipeline has MicroPine intended for the arresting the progression of pediatric myopia and MicroLine, a treatment for improvement of near vision in patients with presbyopia.
Glaukos Corporation (NYSE: GKOS)
Market Cap: $2.4B; Current Share Price: 56.39 USD
Data by YCharts
Glaukos has recently introduced an injectible stents named iStent inject®, which can reduce IOP in adult patients with mild-to-moderate primary open-angle glaucoma, undergoing a cataract surgery. The device is capable of restoring natural outflow, has demonstrated significant reduction in IOP in multiple clinical studies, offers precise outcomes and predictability in procedures and has an excellent safety profile.
The device uses a micro-invasive approach by creating two patent bypass pathways through the trabecular meshwork and facilitates multi-directional flow through Schlemm’s canal, through the smallest medical implantable device. The device is capable of restoring flow in previously dormant outflow channels and presents a far greater micro-invasive and astigmatically-neutral approach. The device also leaves the natural anatomy intact, causing minimal trauma to the eye tissue, preserving the potential for future treatments. It can also prevent hypotony by relying on the natural episcleral venous pressure and has a similar postoperative care profile similar to a cataract surgery.
The Company has recently acquired Avedro (NASDAQ: AVDR), thereby strengthened its corneal health franchise. Avedro’s proprietary, bio-activated, single-use Photrexa® drug formulations can halt the progression of keratoconus, in addition to a pipeline of candidates that offer single application bio-activated topical ophthalmic solutions for common refractive conditions, including presbyopia, low myopia and post-cataract refractive error.
Furthermore the Company is also developing multiple micro-invasive bioerodible, sustained-release drug delivery platforms for treatment of retinal diseases such as age-related macular degeneration (AMD) and diabetic macular edema.
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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