As it awaits an October FDA decision on lifitegrast, a dry eye drug acquired via a 2013 buyout of Sarcode Bioscience Inc., Shire plc is bolstering its ophthalmology offerings with another acquisition, snapping up privately held Foresight Biotherapeutics Inc. for $300 million in cash.

It's an impressive return on investment for investors in Foresight, an under-the-radar biotech that, according to SEC filings, has raised only $17 million since its founding in 2008 by Jason Stein and Michael Weiser to develop drugs for ear, nose and throat indications. The New York-based firm raised $2 million in seed funding in 2011 and added $15 million in November 2013.

Foresight brings to Shire global rights to phase III-ready FST-100, an eye drop formulation combining 0.6 percent povidone iodine (PVP-I) and 0.1 percent of corticosteroid dexamethasone that has the potential to be the first treatment for infectious conjunctivitis that attacks both viral and bacterial infections.

Commonly known as pink eye, infectious conjunctivitis affects more than 11 million people annually across the U.S. and Europe. While there are treatments for infections caused by bacteria – usually antibiotics – there are no approved treatments capable of eradicating adenovirus, the typical cause of viral conjunctivitis. Patients with the viral form – Shire estimates that about half of infectious disease cases have a viral etiology – generally have to wait for the infection to run its course. Worse, most are prescribed antibiotic treatment, which does nothing to kill the virus but contributes to the growing problem of antibiotic resistance.

To date, FST-100 has completed two studies – a two-arm pilot study and a three-arm trial – in a phase II proof-of-concept program specifically looking at adenoviral conjunctivitis. Results from the two-arm trial showed a trend toward efficacy, but Foresight reported that two few subjects tested positive for a viral presence to reach statistical significance on efficacy parameters.

In the three-arm study, in which patients were randomized to receive FST-100, PVP-I alone or vehicle four times daily for five days, those treated with FST-100 showed statistically significant improvement over vehicle in rates of clinical cure and viral eradication at day six (30.6 percent vs. 6.4 percent, p = 0.0033) and demonstrated a trend toward clinical significance with Foresight's combo eye drop when compared to PVP-I alone (30.6 percent vs. 18 percent, p = 0.1432).

Those data were promising enough for Foresight to meet with the FDA to discuss a path toward phase III in adenoviral conjunctivitis. But now that Shire has taken control of the program, the clinical plan also is expected to include testing FST-100 in bacterial conjunctivitis based on promising preclinical data showing the compound has effect against bacterial pathogens.

The Dublin-based pharma hasn't disclosed timing for further trials, but said FST-100 should prove complementary to its ophthalmic commercialization strategy for lifitegrast, a first-in-class molecule designed to inhibit T-cell inflammation by blocking the binding of lymphocytic function-associated antigen-1 and intercellular adhesion molecule-1. That drug hit its endpoint in one phase III trial and met one of two co-primary endpoints in a second phase III study in dry eye disease, results that were sufficient for the FDA to accept a new drug application filing earlier this year and grant priority review. The PDUFA date is Oct. 25.

Shire picked up lifitegrast, which it also is testing in allergic conjunctivitis and diabetic macular edema, in its 2013 buyout of Brisbane, Calif.-based Sarcode for $160 million up front plus undisclosed milestones. (See BioWorld Today, March 26, 2013.)

That deal followed shortly after Shire's acquisition of Premacure AB, of Uppsala, Sweden, gaining rights to Premiplex (insulin growth factor-1) for the prevention of retinopathy of prematurity (ROP), a rare eye disease that affects preterm infants.

According to Cortellis Clinical Trials Intelligence, Shire is currently enrolling patients in the PEDAL study, a long-term efficacy and safety trial for the prevention of ROP. (See BioWorld Today, March 13, 2013.)

Much earlier in the pipeline is a project targeting autosomal dominant retinitis pigmentosa (adRP). Shire purchased Bikam Pharmaceuticals Inc., the lead collaborator on efforts to develop compounds for correcting abnormal forms of opsin, in July 2014. According to a 10-Q filing, the pharma paid $2.5 million up front and agreed to up to $92 million in milestones.

In May 2014, the adRP program got a boost thanks to an agreement with the Foundation Fighting Blindness to further research for a treatment.

About that same time, Shire formed its Ophthalmics Business Unit, aimed at developing drugs for both rare diseases and specialty indications, a move probably not surprising given CEO Flemming Ornoskov's previous stint heading up the pharmaceuticals business at Bausch & Lomb. He called ophthalmology a "highly attractive growth area for Shire," and said Foresight acquisition means Shire will have late-stage programs to "address two of the leading reasons people seek eye care treatment."

The company's shares (NASDAQ:SHPG) closed Monday at $268.08, up $1.27.