Novartis’ Alcon picks up PowerVision for $285m

Alcon, PowerVision

Novartis (NYSE:NVS) subsidiary Alcon said today that it acquired intraocular lens developer PowerVision for $285 million.

PowerVision is developing fluid-based intraocular lens implants that use the eye’s natural accommodating response to transport fluid in the implanted lens, Fort Worth, Texas-based Alcon said.

The fluid-based lens creates a continuously variable monofocal lens using the natural contractions of the eye’s muscles, Alcon said, allowing a patient to actively focus on objects in a style similar to a young eye’s crystalline lens.

“We’re thrilled to officially join Alcon and its pioneering history of launching new innovation in the field of ophthalmology. We look forward to bringing this innovative IOL technology to eye care providers and customers in the years ahead,” PowerVision prez & CEO Barry Cheskin said in a prepared statement.

Alcon said that the commercial availability of the newly acquired IOL devices will be “determined following significant additional development and clinical trials of the intraocular lens.

The deal includes additional payments tied to regulatory and commercial milestones slated to begin 2023, Alcon said.

“As the industry leader in cataract surgery, we’re eager to accelerate development of this potentially breakthrough accommodating lens technology. By treating cataracts and restoring natural, continuous range of vision, this intraocular lens may be the preferred IOL for cataract surgery patients who desire spectacle independence,” Alcon global business and innovation prez Michael Onuscheck said in a press release.

Last December, Alcon said that it acquired Tear Film Innovations for an undisclosed amount.

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Ivantis touts 2-year Hydrus, Glaukos iStent head-to-head study results

IvantisIvantis today released two-year results from a study comparing its Hydrus Microstent to Glaukos‘ (NYSE:GKOS) iStent trabecular micro-bypass stents, touting reductions in medication use and no reoperations for patients in the Hydrus arm.

The Irvine, Calif.-based company said that it is presenting results from the Compare trial today at the American Glaucoma Society’s annual meeting in San Francisco.

“We are extremely pleased with these two year results. These results illustrate the clinical advantages of the Hydrus and its unique, proprietary Tri-Modal mechanism of action relative to focal trabecular bypass.  Clearly, scaffolding the canal has unique benefit.  Of the over 100 peer reviewed publications in the MIGS space, there are only a small handful of prospective, multicenter randomized trials, and Ivantis has conducted nearly half of those, which is a significant achievement for a company that is the most recent to commercialize in the MIGS category.  We are proud to sponsor clinical trials of this caliber, enabling the Compare investigators to advance our understanding of the Hydrus Microstent and the MIGS field overall, and we look forward to the publication of these important two year results. We are grateful to the investigators for their support and contributions,” prez & CEO Dave Van Meter said in a press release.

In the study, Ivantis compared the Hydrus microstent against two large-diameter iStent devices in treating open-angle glaucoma in a stand-alone procedure. A total of 152 patients with mild to late-moderate stage disease were treated at 12 international centers in the trial by surgeons who were “beyond their surgical learning curves for both devices,” the company said.

Results at 24 months indicated that 38% of patients treated with the Hydrus device were medication free, compared to 18.7% of patients in the iStent groups. Medication use was reduced by 1.3 medications, or 52%, on average for Hydrus patients, while iStent patients saw reductions of 0.8, or 29%, Ivantis said.

No Hydrus patients required reoperation to control for glaucoma, while 9% of patients in the iStent group required reoperations, the company said. A total 63% of patients in the Hydrus arm achieved a 20% reduction in intraocular pressure while on fewer meds, compared to 40% of iStent patients. Both groups reported general stability in medication reductions and IOP levels relative to their results at 12 months, the company added.

“The clinical community will be pleased to see 24-month results for the first controlled ‘head-to-head’ trial in the MIGS space, and there are some important and practical takeaways here.  First, although this is a controlled trial, it is quite ‘real world’ in the sense that the surgeons were trained experts in both technologies and the population included a wide range of disease severity.  Second, we know cataract surgery alone is effective at reducing IOP, and, while the predominant application of MIGS today is in conjunction with cataract surgery, the results of this trial allows us great optimism for the role of these technologies as ‘standalone’ procedures.  Third, while not a prespecified endpoint, a critical finding was a statistically significant difference in secondary surgical interventions at 2 years in favor of Hydrus.  Ultimately, the goal of all MIGS – and all glaucoma therapy in general – is to stop progression of disease.  While both devices had overall benefit for the patient, on this metric, Hydrus as a stand-alone procedure was excellent.  This data set is an important contribution to our overall understanding of the role of MIGS devices in our armamentarium,” American Society of Cataract and Refractive Surgeons prez Dr. Thomas Samuelson said in a prepared statement.

Last August, Ivantis said that it won FDA approval for its Hydrus microstent designed to treat patients with mild to moderate primary open-angle glaucoma in conjunction with cataract surgery.

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Aerie wins FDA nod for second glaucoma drug

Aerie Pharmaceuticals - updated logoAerie Pharmaceuticals (NSDQ:AERI) said this week that the FDA approved the company’s once-daily eye drop Rocklatan for the treatment of elevated intraocular pressure in people with open-angle glaucoma or ocular hypertension.

The Durham, N.C.-based company’s product is a fixed-dose combination of latanoprost and netarsudil – the active ingredient in Aerie’s first drug, Rhopressa.

Get the full story at our sister site, Drug Delivery Business News.

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Ocular Therapeutix posts mixed Q4 results

Ocular Therapeutix logoShares in Ocular Therapeutix (NSDQ:OCUL) fell in premarket activity today after the company posted mixed fourth-quarter results.

The Bedford, Mass.-based company posted a net loss of -$17.4 million, or -42¢ per share, on sales of $504,000 for the three months ended Dec. 31, for sales growth of 3.5% compared with the same period last year.

Get the full story at our sister site, Drug Delivery Business News.

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FDA slaps Class 1 designation on corneal implant recall

FDA has upgraded a recall of the Raindrop corneal inlay to Class I, the most serious designation.

Developed by the now-defunct ReVision Optics, the inlay was designed to treat presbyopia. But 75% of patients in a post-approval surveillance study developed corneal hazing. ReVision closed its doors last year; RVO 2.0, doing business as Optics Medical, now owns the Raindrop device and initiated the recall in November, advising customers not to implant the inlay devices. Raindrop is banned from distribution in the U.S., according to FDA.

Lake Forest, Calif.-based ReVision won pre-market approval from the FDA in June 2016 for the Raindrop inlay to treat presbyopia. The device is a microscopic hydrogel inlay placed in the cornea of the patient’s non-dominant eye during a 10-minute procedure to reshape the anterior curvature of the cornea.

The recall covers 2,869 devices distributed between August 2016 and March 2018. FDA issued a safety communication in October, citing a five-year, 150-patient post-approval study. Interim data showed a 42% rate of central corneal haze (63/150), a 75% rate of any corneal haze (113/150) and a 23.3% rate of device removal to date (35/150); of those, some 31% (11/35) had their Raindrop implant removed due to corneal haze, according to the agency.

FDA had initially cleared Raindrop based on two-year clinical data showing a 16.1% rate of central corneal haze (60 of 373 patients), a 1.1% rate of patients with two or more lines of loss in vision (4/373) and a device removal rate of 6.4% (24/373); some 29% of those removals were due to corneal haze (7/24), the agency said.

FDA said it began working with Optics Medical last year to remove the product from the market.

 

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Glaukos rises on Street-beating Q4, 2018 earnings

Glaukos logo

Shares in Glaukos (NYSE:GKOS) are rising today after the ophthalmological-focused medical device maker posted fourth quarter and full year 2018 earnings that topped expectations on Wall Street.

The San Clemente, Calif.-based company posted profits of approximately $1.8 million, or 4¢ per share, on sales of approximately $54.1 million for the three months ended December 31, for bottom-line growth of 76.8% while sales grew 29.8% compared with the same period during the previous year.

Read the whole story on our sister site, Drug Delivery Business News

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Staar Surgical inks deal with Iberian eye clinic group

Staar Surgical

Staar Surgical (NSDQ:STAA) said today it inked a strategic cooperation agreement with ophthalmology clinic group Vista Oftalmólogos to offer its Evo Visian implantable collamer lenses for patients suffering from nearsightedness.

Vista Oftalmólogos is a 49-clinic group across Spain, France, Portugal and Morocco and employs more than 200 eye doctors and has 1,000 employees, Monrovia, Calif.-based Staar Surgical said.

“Providing the highest level of science-backed vision services to ensure satisfied patients is the common endeavor of every Vista clinic and the Evo Visian ICL fulfills that goal fitting seamlessly into our clinics. Some of our surgeons have used the ICL for years while others are just beginning the journey in providing this life-changing vision correction solution to our patients. With the ICL we have the added plus of a manufacturing company that meets our surgeons’ expectations, which is no small feat in this business. This new strategic cooperation agreement with Staar elevates the importance of the ICL in providing our patients a safe quick vision correction procedure with unmatched levels of patient satisfaction,” Vista Oftalmólogos manager Juan Borreguero said in a press release.

Staar Surgical’s Evo ICL is intended to work with a patient’s natural eye to correct vision and eliminate the need for external corrective lenses. The company said that the Evo lens allows for natural aqueous flow and only requires a single surgical procedure.

“In 10 short years Vista Oftalmólogos has established itself as a leading ophthalmology group in Western Europe and we are delighted they have chosen to make our Evo Visian ICL family of lenses a premium and primary procedure in their clinics. Precision manufactured with our exclusive Collamer material the Evo lens has a well-recognized safety and effectiveness record for the more than 500,000 EVO lenses that have been implanted. The Staar team looks forward to working closely with Vista Oftalmólogos on certifying surgeons, patient education and marketing to facilitate broader awareness and use of the ICL,” Staar Surgical prez & CEO Caren Mason said in a prepared statement.

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PE giant brands ophthalmology play as Falcon Vision

Kohlberg Kravis RobertsPrivate equity giant KKR said yesterday that it’s forming a new company to back plays in the ophthalmology space, tapping a well-known expert in the field to lead its new Falcon Vision business.

Based in Menlo Park, Calif., Falcon Vision is slated to collaborate with Flying L Partners and Bill Link, the co-founder of Advanced Medical Optics, Chiron Vision and Versant Ventures, KKR said.

“Ophthalmology is an important and attractive area for innovation given the unmet need across multiple disease categories, an aging population and the quality-of-life consequences of vision loss,” Link said in prepared remarks. “We are eager to collaborate with Falcon Vision to further our mission of supporting innovative companies to create value in the space.”

“There is a significant opportunity to accelerate much-needed therapies in the ophthalmic sector with flexible capital and operational guidance,” added KKR healthcare strategic growth head Ali Satvat. “We are excited to work with the proven team at Flying L Partners to provide companies with the resources that they need in order to advance new products to treat ophthalmic diseases and preserve vision for millions of patients.”

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Oyster Point raises $93m for intranasal dry eye disease therapies

Oyster Point Pharma logoOyster Point Pharma said yesterday that it raised $93 million in a Series B round to support the clinical development of its intranasal dry eye disease therapies.

The Princeton, N.J.-based company’s lead product candidates for dry eye disease are designed to stimulate the trigeminal parasympathetic pathway to trigger natural tear film production. The drugs, OC-01 and OC-02, are delivered using an ocular surface-sparing nasal spray.

Get the full story at our sister site, Drug Delivery Business News.

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Ocular Therapeutix inks $38m debt financing deal

Ocular Therapeutix logoOcular Therapeutix (NSDQ:OCUL) said today that it inked a deal with an investor to issue $37.5 million in 6% subordinated convertible notes due 2026. The offering is slated to close on March 1, according to the Bedford, Mass.-based company.

Ocular expects to reel in roughly $37.1 million in net proceeds from the offering, which it plans to use to fund the launch of Dextenza and support its late-stage pipeline.

Get the full story at our sister site, Drug Delivery Business News.

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