■ Strong US launch of Jetrea. Thrombogenics, the developer of recently approved Jetrea (ocriplasmin), the first pharmaceutical treatment for symptomatic vitreomacular adhesion (VMA), reported that it recorded US sales of $10.2 million in the January 14 through April 30 launch period. Thrombogenics said that 40% of targeted US retina practices have purchased the product and that 50% of those practices have already reordered Jetrea.

Thrombogenics also reported encouraging results from a phase 2a study using Jetrea to treat VMA in patients with wet AMD. At day 28, 24% of the Jetrea-treated patients achieved resolution compared to 12% who received sham injections. The company plans to conduct a larger study to confirm these results.

■ QLT focuses on synthetic retinoids. Having sold its interest in Visudyne photodynamic therapy (PDT) for the treatment of wet AMD to Valeant Pharmaceuticals and its punctal plug drug delivery system to Mati Therapeutics, QLT is now solely focused on its development program for synthetic oral retinoids to treat retinal disease. This program is currently in a phase 2 trial.

The QLT synthetic retinoids are designed to counteract the genetic defects that lead to deficiencies in the key visual component 11-cis-retinal in such diseases as Lebers congenital amaurosis and retinitis pigmentosa.

In addition, QLT has announced it plans to distribute $200 million to shareholders in the form of a special dividend of approximately $3.95 a share. The exact amount of the distribution per share will be finalized in late June.

■ One drawback to combination AMD therapy. With growing interest in combination therapy for the treatment of retinal disease, clinical trials of various combinations are requiring that the patients receive two intravitreal injections at the same visit, usually 30 minutes apart.

Pravin Dugel, MD, who served as a key investigator in Ophthotech’s successful large-scale phase 2b trial combining the anti-pdgf Fovista with ranibizumab, says the greater efficacy and potentially longer duration of effective combination treatments should offset the burden of the double-injection requirement.

■ GenSight funded for RP and Leber’s research. GenSight Biologics, a Paris-based developer of gene therapies for ocular diseases, will receive $41.3 million in venture capital funding for the development of two ocular gene therapies. One is an optogenetic treatment for RP, the other a gene-correction therapy for Leber hereditary optic neuropathy (LHON), a condition that causes central vision loss from degeneration of the optic nerve.

Both treatments are slated to move into clinical trials, with the LHON therapy study expected to start in 2013. GenSight has not yet announced a start date for the optogenetic therapy trial.

■ Study: delayed onset of fungal endophthalmitis. After retrospectively studying a 2012 outbreak of fungal endophthalmitis (Bipolaris hawaiiensis) linked to contaminated triamcinolone syringes sold by a Florida compounding pharmacy, Kent W. Small, MD, of the Molecular Insight Research Foundation in Los Angeles, found that 10 of the 16 eyes injected eventually developed fungal endophthalmitis.

In a study presented at the recent ARVO meeting, Dr. Small noted that the time to onset of signs and symptoms ranged from two weeks to seven months, with a median time of three months. The typical presenting signs were painless loss of vision in an eye that was white and quiet-appearing except for cells in the interior chamber of the vitreous. Vitreous biopsy obtained by pars plana vitrectomy was more sensitive in making the diagnosis of fungal endophthalmitis than was vitreous culture or in-office vitreous taps.

Dr. Small, whose study only dealt with the onset phase of the disease, noted that fungal endophthalmitis, due to an airborne black plant mold, is rare and that its delayed onset can make diagnosis difficult without a documented “outbreak.”

REFERENCE

Small KW. Fungal endophthalmitis onset due to intravitreal triamcinilone contaminated by a compounding pharmacy. Invest Ophthalmol Vis Sci. 2013;54:ARVO E-Abstract 1123.

■ Stanford to participate in stem cell trial. StemCells, Inc., announced the addition of the Byers Eye Institute at Stanford, Palo Alto, CA, as a second site for the company’s phase 1/2 clinical trial of its proprietary HuCNS-SC product candidate (purified human neural stem cells) in dry AMD. The first site to announce its participation in the study is the Retina Foundation of the Southweat in Dallas.

Theodore Leng, MD, FACS, clinical assistant professor in ophthalmology at the Stanford University School of Medicine, is the lead investigator at the site.

“The company’s preclinical data indicates that transplanting neural stem cells to protect photoreceptors may prove to be a viable approach to this debilitating disease. The (preclinical) data provides a very strong rationale for this innovative cell therapy trial,” said Dr. Leng.

“The clinical strategy with our neural stem cells is to preserve visual function before it is lost,” said Stephen Huhn, MD, FACS, FAAP, vice president and head of the human neural stem cells program at StemCells, Inc. “Our published preclinical data supports this approach in dry AMD and we will hope to replicate those results in this clinical trial.”

■ Regeneron to expand NY facilities. Regeneron Pharmaceuticals, developer of Eylea for the treatment of wet AMD and macular edema associated with CRVO, will expand its corporate headquarters and laboratories in Westchester County, NY, and create more than 400 new high-skill jobs.

The project will add two new buildings with 300,000 square feet of laboratory and office space to the Regeneron complex in the town of Mount Pleasant. Currently, Regeneron occupies approximately 590,000 square feet of space at the site and will occupy another 85,000 square feet of additional space there later this year. Construction of the new buildings is anticipated to begin in late 2013 and to be completed in late 2015.

■ Surgical masks no factor in endophthalmitis prevention. A study conducted by Erin Lessner, MD, of the University of South Carolina Department of Ophthalmology, set out to determine whether intravitreal injections would be safer if given with the physician wearing a surgical mask. One set of 25 patients was injected while the doctor was wearing a mask and another set of 25 patients was injected with the same doctor not wearing a mask. Other factors were the same for both groups, with the same antibiotics given to both groups pre- and post-injection. When not wearing a mask, the physician did not talk during the procedure.

No incidents of endophthalmitis were reported in either group. The researcher believes that larger studies are needed to see if wearing a mask can serve as an infection preventative, especially if the physician has a respiratory infection while performing intravitreal injections.

■ Alimera gets PDUFA date for Iluvien. Alimera Sciences said its recent resubmission of the New Drug Application for its Iluvien sustained-release implant for DME has been acknowledged by the FDA as a complete class 2 response and that a new Prescription Drug User Fee Act (PDUFA) goal date of October 17, 2013 has been established. RP