In a move characterized by President and CEO Stephen From as “potentially transformative,” Eyegate Pharmaceuticals Inc. enticed Valeant Pharmaceuticals International Inc. to an exclusive global licensing agreement for commercial and manufacturing rights to lead candidate, EGP-437, a combination of the reformulated corticosteroid, dexamethasone phosphate, delivered into the ocular tissues using the company’s Eyegate II delivery system. Valeant gained rights to the combo drug/device candidate in the field of anterior uveitis, with a right of last negotiation to license the product in additional indications, such as macular edema.

Amounts were not disclosed, but Waltham, Mass-based Eyegate is set to receive an up-front cash payment along with development and regulatory milestones for the uveitis indication. The company also is eligible for royalties on net sales and additional milestone payments on the achievement of undisclosed sales targets.

Eyegate retained responsibility and will foot the bill to complete the development of EGP-437 in the U.S. in anterior uveitis, but Valeant, of Laval, Quebec, assumed the right to develop the product in uveitis – and to bear 100 percent of those costs – elsewhere.

A jubilant From said the deal validated the company’s technology and ensured an approved product will go to market.

“Now that I have Valeant as a partner, I know this product will be commercialized,” From told BioWorld Today. “Do you know how exciting that is for us? A lot of small companies spend a lot of time and resources on products that never end up being commercialized. We could probably have done this on our own, but nowhere near what Valeant will be able to do.”

Investors were pumped, too. On Friday, Eyegate’s shares (NASDAQ:EYEG) shot to a one-year high of $6.65 before closing at $6.15 for a gain of $1.45, or 30.9 percent.

Eyegate has been around for more than a decade, and From had forged relationships “with all of the ophthalmology companies,” he said. Conversations with Valeant turned serious last year at the annual meeting of the American Academy of Ophthalmology in Chicago.

“Valeant is very eager to do deals like this,” he said. “In comparison to the huge transactions they’re doing, this is just a tiny little deal. But they did a lot of work very quickly once they decided they wanted to go forward.”

From named Valeant – which in 2013 acquired eye care specialist Bausch & Lomb Inc. for $8.7 billion – as one of three major players in the ophthalmology space. The others, he said, include Allergan Inc., which went to Actavis plc, of Dublin, last year for $66 billion after a bidding war with Valeant, and Alcon Inc., picked up by Novartis AG, of Basel, Switzerland, in 2010 after the pharma took a 25 percent stake two years earlier. (See BioWorld Today, Nov. 18, 2014.)

“To do a licensing deal with one of those three validates the power of our platform,” he emphasized. “Being able to launch a new platform to deliver drugs into the eye hasn’t been done in a long time.”

MOVE ‘FIRST MOLECULE FORWARD AS FAR AS POSSIBLE’

The Eyegate platform, based on technology that originated at the University of Miami’s Bascom Palmer Eye Institute, uses a low-level electrical current to deliver a specific amount of drug for each treatment.

Powered by iontophoresis, the non-invasive delivery system mitigates noncompliance and other risks associated with topical drops as well as safety issues and limitations on provider availability associated with invasive injections, since the Eyegate delivery system can be used by nursing and other nonphysician staff.

To date, the system has been used in more than 1,700 subjects during clinical trials, with more than 1,000 of those receiving the company’s lead therapeutic candidate.

Valeant saw the value of the company’s new-generation iontophoresis technology, “and that’s something I can hold up high to the rest of the world,” From maintained. “Other companies are delivering corticosteroids for delivery into the eye through other methods, but none of them has a licensing transaction with any of the top three.”

Perhaps the closest competitor to Eyegate’s technology is Clearside Biomedical Inc., of Alpharetta, Ga., which is developing a drug/device combo to deliver a single suprachoroidal injection of a formulation of preservative-free triamcinolone acetonide suspension using a microinjector. The company is running a randomized phase II trial for the treatment of macular edema associated with non-infectious uveitis.

In April, Clearside inked an option agreement giving Spark Therapeutics Inc., of Philadelphia, licensing rights to Clearside’s microinjector technology to deliver viral vectors to the choroid and the retina through the suprachoroidal space. Clearside also has a research agreement with Santen Inc., a wholly owned subsidiary of Santen Pharmaceuticals Co. Ltd., of Osaka, Japan, to develop drugs for diseases that afflict the retina and choroid and can lead to blindness, using Clearside’s microinjector technology.

Kala Pharmaceuticals Inc., of Waltham, Mass., recently completed a phase III study of lead compound, KPI-121, a topical nanoparticle formulation of loteprednol etabonate (Lotemax, Bausch & Lomb), using the company’s mucus-penetrating particle (MPP) technology to enhance penetration in target eye tissue.

The company’s lead indication is reduction of inflammation and pain following cataract surgery – the same path Insite Vision Inc., of Alameda, Calif., is pursuing with its lead drug, Bromsite (ISV-303). Neither company is pursuing uveitis, but Kala could become a competitor in Eyegate’s follow-on indication in macular edema. (See BioWorld Today, March 20, 2013, and April 2, 2015.)

Icon Bioscience Inc., of Sunnyvale, Calif., also has a pipeline of drugs targeting ophthalmic indications, with lead candidate IBI-10090, designed to treat inflammation associated with cataract surgery. The company’s Verisome platform is designed to deliver a controlled, sustained-release formulation of the anti-inflammatory dexamethasone through a single injection into the anterior chamber of the eye. (See BioWorld Today, June 30, 2014.)

Aciont Inc., of Salt Lake City, also has a uveitis candidate far back in the pipeline.

Ophthalmic drug developer Aciex Therapeutics Inc., of Boston, took a different tack to propel its pipeline toward commercialization last year in the form of an all-stock acquisition by Nicox SA, of Sophia Antipolis, France. Aciex was developing a formulation of the corticosteroid fluticasone, based on its nanocrystallization technology, and its lead product, AC-170 (cetirizine dihydrochloride), completed two phase III trials in allergic conjunctivitis and was in position for a new drug application (NDA) filing. (See BioWorld Today, July 3, 2014.)

Eyegate still has to conduct a phase III trial of EGP-437, expected to begin recruiting shortly, which will take about one year to enroll, as well as a small safety study, From said, noting that both study designs have received the FDA’s blessing. The randomized, multicenter, double-blind, parallel-arm phase III will evaluate the Eyegate candidate against standard-of-care prednisolone acetate ophthalmic suspension, according to Cortellis Clinical Trials Intelligence.

The trial is expected to enroll approximately 250 patients at some 60 U.S. sites, evaluating the proportion of patients treated with EGP-437 who have total anterior chamber cell clearing at day 14 compared to control.

Provided results match the company’s previous success, Eyegate will move directly to an NDA filing through the 505(b)(2) pathway. Although EGP-437 is a combination product, the FDA plans to review the application through the Center for Drug Evaluation and Research.

Beyond its corticosteroid, Eyegate plans to pursue its delivery technology in combination with other molecules.

The company has a number of candidates still at the discovery stage, according to Cortellis Competitive Intelligence, including assets for glaucoma, conjunctivitis, age-related macular degeneration (AMD) and wet AMD.

“The idea was to move this first molecule forward as far as possible until we could get an agreement with one of the majors, and that’s what we’ve done,” From said.

Although the Valeant deal brings some cash, Eyegate plans to move quickly to raise additional funds, subsequent to an S-1 filed last month with the SEC for an offering of up to $15 million. In its filing, the company reported cash and equivalents of approximately $2.3 million as of March 31.

“There are other things we want to do beyond corticosteroids,” From said, “so I’d like to get our balance sheet in a stronger position than it is now.”