Quick Hits

OTX begins key trial; obtains new funding

Baxter makes equity investment in company.

Ocular Therapeutix (OTX) has completed enrollment for its sustained-release dexamethasone, known as OTX-DP, in a phase 2 study under an Investigational New Drug submission to the FDA. This study will evaluate the safety and efficacy of OTX-DP for the treatment of postoperative inflammation and pain. The company also received a minority equity investment of an undisclosed amount from Baxter Ventures, the venture capital arm of Baxter International.

Ocular Therapeutix’s sustained-release dexamethasone is administered as a one-time bioabsorbable intracanalicular plug, and releases the corticosteroid to the ocular surface over a two-week period followed by a two-week taper. Sixty patients undergoing clear corneal cataract surgery were enrolled at four sites in the United States. Patients randomized to the OTX-DP study arm were administered the drug-eluting plug at the conclusion of surgery, and a proprietary placebo intracanalicular plug was placed in the control group.

Primary endpoints are reduction of inflammation and pain. OTX contends that patients do not reliably self-administer steroids post-surgery, and as a result risk greater or more persistent postoperative inflammation that can ultimately compromise visual outcomes. In addition, topical steroids are known to induce spikes in intraocular pressure.

“A sustained, low-dose dexamethasone plug could ensure consistent and continuous corticosteroid concentrations on the ocular surface, which may in turn minimize side effects and achieve better results,” says Amar Sawhney, PhD, president and CEO of Ocular Therapeutix.

BAXTER INVESTMENT IN OTX

In regard to the new funding, Baxter Ventures was established by its parent company in 2011 with $200 million to invest in early-stage health-care companies that show promise.

The Baxter Ventures funding will help further the development of Ocular Therapeutix’s sustained-release drug programs, which include prostaglandin analogs for the treatment of glaucoma, and corticosteroids for treatment of postoperative inflammation and pain. The funding will also support the commercial launch of the ReSure Sealant in the United States, an alternative to sutures in sealing leaking clear-corneal incisions in cataract surgery.

“Through our investment in Ocular Therapeutix, we are continuing to incubate innovation that has the potential to address areas of unmet need, provide sustainable long-term growth potential and offer a sustainable competitive advantage,” says Geeta Vemuri, vice president and head of Baxter Ventures.

High court will permit ‘pay-for-delay’ lawsuits.

Split vote draws strong opinions.

By Jerry Helzner, Senior Editor

In the world of business-related compromises, one of the most frequent has been the increasing instances of major drug companies paying generic drug manufacturers significant amounts not to challenge the validity of the majors’ existing patents. In these cases, companies work out a deal that provides patent protection for the branded drug while also making concessions of money and earlier entry to the generic firm.

But in June, the US Supreme Court voted 5 to 3 to allow the Federal Trade Commission to challenge these deals if they appear designed to keep a cheaper generic drug off the market to the detriment of patients and payers.

In writing the minority opinion, Chief Justice John Roberts contended that compromises that avoid costly and time-consuming litigation generally produce a positive result.

“The majority’s rule will discourage settlement of patent litigation,” Justice Roberts asserted. “Simply put, there would be no incentive to settle if, immediately after settling, the parties would have to litigate the same issue as part of a defense against an antitrust suit.”

But in writing the majority opinion, Justice Stephen Breyer asserted “this court’s precedents make clear that patent- related settlement agreements can sometimes violate antitrust law.”

Update on MOC requirements

The program has evolved in recent years.

The American Board of Ophthalmology (ABO) says its Maintenance of Certification (MOC) program is a lifelong learning and practice improvement process designed to establish and maintain the highest standards of ophthalmic practice. Since MOC began in 2006, ABO says the program has evolved in response to the need for public accountability and transparency, as well as the needs of its diplomates.

The ABO MOC program is completed in the following four main parts over the course of 10 years:

. Part I, Professional Standing, requires a valid and unrestricted license to practice medicine in the United States and its territories and Canada.

. Part II, Lifelong Learning and Self-Assessment, requires submission of 25 CME credits per year, eight of which must contain a self-assessment component. Additionally, diplomates complete two online, on-demand 50-question self-assessment tests: one in core ophthalmic knowledge and one in a practice emphasis area of their choice. These tests are designed to help diplomates prepare for their Part III cognitive examination.

. Part III, Cognitive Expertise, requires successful completion of a closed-book, proctored, 150-question examination, offered at testing centers nationwide each September.

. Part IV, Practice Performance Assessment, requires completion of a practice performance assessment once in years 1-5 and again in years 6-10. The practice improvement modules (PIMs) are self-directed online activities that assist ophthalmologists in evaluating their practice, identifying potential gaps in care, targeting specific individual measures for improvement, developing and implementing an improvement plan, and remeasuring to ascertain the level of improvement in patient outcomes.

Twenty three modules are now available to ophthalmologists, with additional modules anticipated later in 2013. Completion of a PIM is also a core component of the CMS elective PQRS:MOC incentive program, for which the ABO’s MOC program is approved in 2013.

Further information and registration is available at abop.org. The ABO’s Web site includes a newly launched diplomate portal, which features illustrated, color-coded activities and information designed to guide diplomates step-by-step through their MOC cycle.

Eyedrop treatments are tried for combating wet AMD

An update on three companies’ efforts.

The emergence in the last decade of new anti-VEGF therapies that can reverse AMD-related vision loss has been hailed as one of the major breakthroughs of modern medicine. However, whatever the merits of Lucentis (ranibizumab, Roche), Eylea (aflibercept, Regeneron) and Avastin (bevacizumab, Roche), the burden placed on both patients and retina specialists of regular intravitreal injections is such that efforts are under way to find new ways to deliver the drugs in a more patient-friendly manner. Among the concepts being explored are eyedrops.

Currently, three companies have been making efforts in this area. Here is the latest information on each company’s progress.

GlaxoSmithKline has recently conducted a 12-week, 19-patient phase 2 trial for an eyedrop form of its tyrosine kinase inhibitor Votrient (pazopanib), which already has FDA approval as a treatment for liver cancer. In an earlier phase 2a trial, the drug produced mean 4.3-letter gains at day 28 in patients given the highest dose, although it did not have an appreciable effect in reducing the central macular thickness that is also a sign of the disease. But in this latest trial, investigator Rishi Singh, MD, of the Cole Eye Institute of the Cleveland Clinic, reported in an ARVO presentation that pazopanib was ineffective in both improving visual acuity and reducing central macular thickness.

GlaxoSmithKline said pazopanib would no longer be studied for wet AMD.

A second company pursuing an eyedrop format for wet AMD is Ohr Pharmaceutical of New York. Ohr purchased the rights to the antiangiogenic aminosterol squalamine from Genaera, which had earlier studied the drug for a time as an intravenously administered treatment for wet AMD.

Ohr recently began a 120-patient, nine-month phase 2 trial of squalamine eyedrops for wet AMD. Retina specialists initially administer a ranibizumab injection. Patients then begin to self-administer the squalamine eyedrop twice a day. No further ranibizumab injections will be given unless specific rescue criteria are met during monthly examinations over the treatment period. Long intervals would speak to the effectiveness of the eyedrop in maintaining vision.

Finally, Opko Health announced in July 2012 that it had engaged a “prominent” Mexican ophthalmologist (name not disclosed) to develop a topical version of Lucentis. A company spokesperson recently said he could provide no information beyond what was in a July 2012 news release.